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  • 1. Baba, Kerstin
    et al.
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Lindh, Jack
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Use of a modified ESAS in cancer patients: a pilot study of patient and staff experiences2007In: International Journal of Palliative Nursing, ISSN 1357-6321, E-ISSN 2052-286X, Vol. 13, no 12, p. 610-616Article in journal (Refereed)
    Abstract [en]

    Aim: To evaluate the feasibility of a modified Edmonton Symptom Assessment Scale (ESAS) for monitoring symptoms in oncological palliative care.

    Methods: A modified ESAS was delivered daily to 28 patients with advanced cancer. A questionnaire to discover staff members’ opinions on the ESAS was delivered at the end of the study. Structured interviews were used to examine patients’ opinions on the ESAS.

    Results: The mean total ESAS score was 28.9 on inclusion day and 25.8 on Day 3 (p=0.531). Eleven of 21 of the staff considered the ESAS to be a ‘good’ or ‘very good’ way to obtain information about patients’ symptoms. Seventeen of 24 patients who participated in the interview felt that ESAS was easy to fill in, and that there were no missing questions.

    Conclusion: The patients felt that the modified ESAS contained relevant symptoms, and that the questionnaires were easy to fill in. The staff considered the modified ESAS to be a useful instrument for obtaining information about patients’ symptom distress. The modified ESAS is a good instrument for use as part of the daily clinical routine, as well as for monitoring symptoms in palliative oncological care.

  • 2.
    Byenfeldt, Marie
    et al.
    Umeå University, Faculty of Medicine, Department of Nursing.
    Elvin, Anders
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Nursing.
    Influence of Probe Pressure on Ultrasound-Based Shear Wave Elastography of the Liver Using Comb-Push 2-D Technology2019In: Ultrasound in Medicine and Biology, ISSN 0301-5629, E-ISSN 1879-291X, Vol. 45, no 2, p. 411-428Article in journal (Refereed)
    Abstract [en]

    It has been postulated that in the liver, applying increased probe pressure during ultrasound-based shear wave elastography (SWE) might lead to a false increase in the SWE result. We aimed to determine the influence of increased intercostal probe pressure when performing SWE of the liver. We also investigated the number of measurements required to achieve technically successful and reliable SWE examinations. This prospective, clinical study included 112 patients and 2240 SWE measurements of the liver. We applied probe pressure intercostally, to reduce the skin-to-liver capsule distance (SCD), which could stabilize the SWE signal and thus increase the number of technically successful measurements. We performed 10 measurements with maximum probe pressure and 10 with normal pressure in each patient. Thus, two analysis groups were compared for differences. Compared with normal pressure, maximum probe pressure significantly reduced the SCD (p < 0.001) and significantly increased the number of technically successful measurements from 981 to 1098, respectively (p < 0.001). The SWE results with normal and maximum probe pressure were 5.96 kPa (interquartile range: 2.41) and 5.45 kPa (interquartile range: 1.96), respectively (p < 0.001). In obese patients, a large SCD poses a diagnostic challenge for ultrasound SWE. We found that maximum intercostal probe pressure could reduce the SCD and increase the number of technically successful measurements, without falsely increasing the SWE result. Only three measurements were required to achieve technically successful and reliable SWE examinations.

  • 3.
    Byenfeldt, Marie
    et al.
    Umeå University, Faculty of Medicine, Department of Nursing.
    Elvin, Anders
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Nursing.
    On patient related factors and their impact on ultrasound-based shear wave elastography of the liver2018In: Ultrasound in Medicine and Biology, ISSN 0301-5629, E-ISSN 1879-291X, Vol. 44, no 8, p. 1606-1615Article in journal (Refereed)
    Abstract [en]

    The aim of the study was to investigate patient-related factors associated with either reliable or poorly reliable measurement results of ultrasound-based shear wave elastography (SWE) of the liver. A total of 188 patients were analyzed prospectively with binary logistic regression using the interquartile range/median as cutoff to define two groups based on reliable and poorly reliable SWE results. SWE results correlated significantly with liver biopsy. Factors associated with reliable SWE results (i.e., no negative impact on measurements) were age, sex, cirrhosis, antiviral and/or cardiovascular medication, smoking habits and body mass index. Factors associated with poorly reliable SWE results were increased skin-to-liver capsule distance (odds ratio = 3.08, 95% confidence interval: 1.70-5.60) and steatosis (odds ratio =2.89, 95% confidence interval: 1.33-6.28). These findings indicate that the interquartile range/median as a quality parameter is useful in avoiding poorly reliable SWE results. How best to examine patients with increased skin-to-liver capsule distance is a matter of some controversy, as the incidences of obesity, diabetes and metabolic syndrome are increasing worldwide; however, our results indicate that reliable SWE results can be obtained in this group of patients by using ultrasound-based SWE. (Email: marie.byenfeldt@umu.se, Marie.byenfeldt@aleris.se ) 

  • 4. Carlsson, Sigrid
    et al.
    Drevin, Linda
    Loeb, Stacy
    Widmark, Anders
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Franck Lissbrant, Ingela
    Robinson, David
    Johansson, Eva
    Stattin, Pär
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Nursing.
    Population-based study of long-term functional outcomes after prostate cancer treatment2016In: BJU International, ISSN 1464-4096, E-ISSN 1464-410X, Vol. 117, no 6B, p. E36-E45Article in journal (Refereed)
    Abstract [en]

    OBJECTIVE: To evaluate long-term urinary, sexual and bowel functional outcomes after prostate cancer treatment at a median follow-up of 12 years (IQR 11-13).

    PATIENTS AND METHODS: In this nationwide, population-based study, we identified from the National Prostate Cancer Register, Sweden, 6,003 men diagnosed with localized prostate cancer (clinical local stage T1-2, any Gleason score, prostate specific antigen < 20 ng/mL, NX or N0, MX or M0) between 1997 and 2002 who were ≤70 years at diagnosis. 1,000 prostate cancer-free controls were selected, matched for age and county of residence. Functional outcomes were evaluated with a validated self-reported questionnaire.

    RESULTS: Responses were obtained from 3,937/6,003 cases (66%) and 459/1,000 (46%) controls. Twelve years post diagnosis, at a median age of 75 years, the proportion of cases with adverse symptoms was 87% for erectile dysfunction or sexually inactive, 20% for urinary incontinence and 14% for bowel disturbances. The corresponding proportions for controls were 62%, 6% and 7%, respectively. Men with prostate cancer, except those on surveillance, had an increased risk of erectile dysfunction, compared to control men. Radical prostatectomy was associated with increased risk of urinary incontinence (odds ratio; OR 2.29 [95% CI 1.83-2.86] and radiotherapy increased the risk of bowel dysfunction (OR 2.46 [95% CI 1.73-3.49]) compared to control men. Multi-modal treatment, in particular including androgen deprivation therapy (ADT), was associated with the highest risk of adverse effects; for instance radical prostatectomy followed by radiotherapy and ADT was associated with an OR of 3.74 [95 CI 1.76-7.95] for erectile dysfunction and OR 3.22 [95% CI 1.93-5.37] for urinary incontinence.

    CONCLUSION: The proportion of men who suffer long-term impact on functional outcomes after prostate cancer treatment was substantial.

  • 5. Degerfält, J. E.
    et al.
    Sjöstedt, S.
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Nursing.
    Kjellén, E.
    Werner, M. U.
    E-learning programs in oncology: a nationwide experience from 2005 to 20142016In: International Journal of Radiation Oncology, Biology, Physics, ISSN 0360-3016, E-ISSN 1879-355X, Vol. 96, no 2, p. E413-E414Article in journal (Refereed)
  • 6.
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Nursing.
    Fatigue in prostate cancer patients treated with external beam radiotherapy: a prospective 5-year long-term patient-reported evaluation2010In: Journal of Cancer Research and Therapeutics, ISSN 0973-1482, E-ISSN 1998-4138, Vol. 6, no 4, p. 516-520Article in journal (Refereed)
    Abstract [en]

    Background: Limited information is available regarding the long-term effect of external beam radiotherapy (EBRT) on fatigue in individuals with prostate cancer (PC).

    Materials and Methods: Men with PC treated with EBRT from January 1992 to June 2003 were enrolled in a prospective study. The QLQ-C30 questionnaire was used to evaluate pre-treatment fatigue and up to 5 years post-treatment.

    Results: 407 men with 5-year assessments were analyzed. Fatigue increased between pre-treatment (mean: 15.5; CI: 13.6-17.4) and 5-years post-treatment (mean: 22.8; CI: 20.5-25.1; P<0.001). Pre-treatment fatigue was absent in 206/407 (59%) patients and 5-year post-treatment was reported by 264/407 (66%). Sixteen of 407 patients (4%) reported severe fatigue after 5 years. Physical-, emotional-, cognitive function, and dyspnea were the factors that correlated most to higher level of fatigue 5-year post-treatment.

    Conclusions: Fatigue is a common symptom among patients with PC. A large percentage of patients reported pre-treatment fatigue. Fatigue increased over time, with the highest level seen at the end of EBRT. Severe fatigue was reported by 4% 5-year post-treatment. More work is needed in order to identify which patients are most susceptible to developing fatigue especially during radiotherapy.

  • 7.
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Patient-reported lower urinary tract symptoms, urinary incontinence, and quality of life after external beam radiotherapy for localized prostate cancer - 15 years' follow-up. A comparison with age-matched controls2008In: Acta Oncologica, ISSN 0284-186X, E-ISSN 1651-226X, Vol. 47, p. 852-861Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: To prospectively examine the urinary toxicity and quality of life (QOL) in patients 15 years after external beam radiotherapy (EBRT) for localized prostate cancer (LPC) and compare the outcomes with results for age-matched controls.

    MATERIAL AND METHODS: Urinary symptoms were assessed using the symptom-specific Prostate Cancer Symptom Scale (PCSS) questionnaire, and QOL was assessed with the European Organization for Research and Treatment of Cancer (EORTC)'s Quality of Life Questionnaire (QLQ-C30). Both questionnaires were sent to the surviving 41 patients(25%) and the PCSS questionnaire was sent to 69 age-matched controls for comparison.

    RESULTS: The response rate was 71% in the patient group and 59% in the control group. Two patients and four controls were excluded due to other cancer diagnoses, resulting in a total of 27 patients and 37 controls for inclusion in the analyses. The mean age in both groups was 78 years. In the patient group, incontinence had increased between the 8-year (mean 0.6) and the 15-year follow-up (mean 2.1; p0.038). No other differences in urinary problems were seen between these two follow-ups. Increased incontinence, stress incontinence, and pain while urinating were reported by the patients in comparison with the controls at 15 years. Role function was worse in the patient group (mean 67.3) compared with the controls (mean 82.4; p0.046). The patients also reported more appetite loss, diarrhea, nausea/vomiting, and pain than the controls.

    CONCLUSION: EBRT for LPC has divergent effects on urinary symptoms and QOL in comparison with age-matched controls. In our patient population, urinary incontinence increased between 8 and 15 years of follow-up. Otherwise, no differences in urinary symptoms were seen between 4 and 15 years. Incontinence, stress incontinence, and pain while urinating were increased after EBRT in comparison with the controls. Conventional EBRT did not result in a major deterioration in QOL 15 years after treatment.

  • 8.
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Quality of life and side effects in patients with localized prostate cancer: evaluation with self-assessment questionnaires2000Doctoral thesis, comprehensive summary (Other academic)
    Abstract [en]

    Localized prostate cancer (LPC) is predominantly a tumor among older men, and few patients will get symptoms from the disease. All methods to treat LPC with a curative intent have different types and degrees of side effects. It is therefore very important to evaluate the side effects thoroughly to make sure that treatment complications will not decrease the quality of life more than the disease would have done. In search for new and better treatments, complications has to be registered and evaluated in relation to quality of life (QOL) for the patients. Few validated self-assessment questionnaires for evaluation of external radiotherapy (EBRT) induced side effects has yet been developed. The present project focus on the development of the PC-specific questionnaire, QUFW94, and evaluation of symptoms in patients treated with EBRT and un-treated (watchful waiting) patients with a LPC.

    In the newly developed LPC-specific questionnaire a reliability and responsiveness test was performed. Both the inter-rater test and the test-retest show high correlation coefficients (ICC), above 0.60 for all scales. The internal reliability exceeded the lower acceptable limit (Cronbach a >0.70). The questionnaire was proven to be valid for the evaluations of EBRT side effects in LPC patients.

    Late side effects were evaluated 4 years after treatment in 181 LPC patients, treated with conventional large field EBRT, and compared with 141 age-matched PC disease free men. The most prominent urinary side effects were urgency and leakage which were doubled in the patient group. A ten fold increase was seen in comparison to controls at the most prominent intestinal problems, blood, mucus and leakage. The results support the use 3-D conformai therapy to decrease irradiation dose to the rectum and the bladder and thereby decreased side effects. A prospective additional evaluation 8 years after EBRT did not show any changes in urinary problems between 4 and 8-yr follow-up in the patients or the controls.

    EBRT of LPC is also accompanied by disturbances in sexual function. These problems were therefore evaluated, 4 years after EBRT, in relation to the function in PC free men. Patients treated with EBRT indicated higher levels of sexual dysfunction than age-matched controls. No erection was reported from 12% of the control subjects, 56% of the patients who had only received radiotherapy (RT) and 87% of the RT+castration (RT+A) patients. The extended evaluation 8 years after EBRT show similar sexual function in all groups.

    QOL and late side effects/symptoms were evaluated in the first and only randomized trial between RT and deferred treatment (DT) and compared to age-matched controls. QOL was evaluated with the general QOL formula, EORTC's QLQ-C30 (+3), and LPC specific side effects with QUFW94 in 108 randomized patients with LPC 3 years after diagnosis. Social functioning was the only QOL scale where a significant difference was found between the two patient groups and in comparison with the control group. Multivariate regression analysis showed that hematuria, incontinence, mucus, and planning of the daily activities due to intestinal problems caused this decrease in QOL in the RT group. In conclusion, the LPC specific QUFW94 questionnaire was proven to be valid for evaluation of side effects and showed increased intestinal problems in the patients treated with conventional large field EBRT in comparison to untreated LPC patients. No difference in urinary and intestinal late side effects or sexual function was seen between a 4 year vs. 8 year follow-up.

  • 9.
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology. Umeå University, Faculty of Medicine, Department of Nursing.
    Quality of life for members of Swedish Prostate Cancer Patient Associations2008In: Cancer Nursing, ISSN 0162-220X, E-ISSN 1538-9804, Vol. 31, no 1, p. 23-31Article in journal (Refereed)
    Abstract [en]

    Prostate Cancer Patient Associations (PCPAs) have become common. The aim of this study was to evaluate the quality of life of patients belonging to PCPAs. Members of 10 PCPAs in Sweden with prostate cancer completed 2 quality of life questionnaires (Quality-of-Life Questionnaire [QLQ-C30] and Prostate Cancer Symptom Scale). Of 2,028 members, 1,301 (64%) responded to the survey. Sixty percent of the members felt "healthy," and 38% were "free from the cancer." Ninety-five percent scored >80 on the physical function scale compared with 44% on the overall quality of life/health scale. The most severe symptom was sleeping disturbances (mean = 29). Seventeen percent scored "Quite a bit/Much" tiredness. More than 50% did not report any bladder or bowel problems. Fifty percent had "Much" sexual problems, and almost 80% did not have sufficient erection. Those reported as being "disease free" scored higher on the functioning scales than those with "metastatic disease." Those with an experience of a "metastatic disease" had more symptoms than those with less advanced disease. This is the first descriptive study of quality of life in members of Swedish PCPAs with prostate cancer. These findings show that it is possible to gain valid data to further study the situation of patients living with prostate cancer by collecting data from PCPAs.

  • 10.
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology. Umeå University, Faculty of Medicine, Department of Nursing.
    Recall of pretreatment symptoms among men treated with radiotherapy for prostate cancer2005In: Acta Oncology, ISSN 0284-186X, Vol. 44, no 4, p. 355-361Article in journal (Refereed)
  • 11.
    Fransson, Per
    et al.
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Bergström, Per
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Löfroth, Per-Olov
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Radiation Physics.
    Widmark, Anders
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Five-year prospective patient evaluation of bladder and bowel symptoms after dose-escalated radiotherapy for prostate cancer with the Beamcath (R) technique2006In: International Journal of Radiation Oncology, Biology, Physics, ISSN 0360-3016, E-ISSN 1879-355X, Vol. 66, no 2, p. 430-438Article in journal (Refereed)
    Abstract [en]

    Purpose: Late side effects were prospectively evaluated up to 5 years after dose-escalated external beam radiotherapy (EBRT) and were compared with a previously treated series with conventional conformal technique.

    Methods and Materials: Bladder and bowel symptoms were prospectively evaluated with the Prostate Cancer Symptom Scale (PCSS) questionnaire up to 5 years posttreatment. In all, 257 patients completed the questionnaire 5 years posttreatment. A total of 168 patients were treated with the conformal technique at doses <71 Gy, and 195 were treated with the dose-escalated stereotactic BeamCath® technique comprising three dose levels: 74 Gy (n = 68), 76 Gy (n = 74), and 78 Gy (n = 53).

    Results: For all dose groups analyzed together, 5 years after treatment, urinary starting problems decreased and urinary incontinence increased in comparison to baseline values. No increase in other bladder symptoms or frequency was detected. When comparing dose groups after 5 years, both the 74-Gy and 78-Gy groups reported increased urinary starting problems compared with patients given the conventional dose (<71 Gy). No increased incontinence was seen in the 76-Gy or the 78-Gy groups. Bowel symptoms were slightly increased during the follow-up period in comparison to baseline. Dose escalation with stereotactic EBRT (74–78 Gy) did not increase gastrointestinal late side effects after 5 years in comparison to doses <71 Gy.

    Conclusion: Dose-escalated EBRT with the BeamCath® technique with doses up to 78 Gy is tolerable, and the toxicity profile is similar to that observed with conventional doses <71 Gy.

  • 12.
    Fransson, Per
    et al.
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Damber, Jan-Erik
    Department of Urology, Göteborg University, Göteborg, Sweden.
    Tomic, Radisa
    Umeå University, Faculty of Medicine, Department of Surgical and Perioperative Sciences, Urology and Andrology.
    Modig, Hans
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Nyberg, Gunnar
    Department of Urology, Boden Hospital, Boden, Sweden.
    Widmark, Anders
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Quality of life and symptoms in a randomized trial of radiotherapy versus deferred treatment of localized prostate carcinoma2001In: Cancer, ISSN 0008-543X, E-ISSN 1097-0142, Vol. 92, no 12, p. 3111-3119Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Treatment of localized prostate carcinoma (LPC) using radiotherapy (RT) can induce disturbances in a patient's quality of life (QOL) and urinary and intestinal function. Late symptoms and QOL were evaluated in a randomized trial between RT and deferred treatment (DT).

    METHODS: Quality of life was evaluated with European Organization for Research and Treatment of Cancer's QLQ-C30 (+3) formula. Urinary and intestinal problems were evaluated with a validated symptom specific self-assessment questionnaire, QUFW94. The questionnaires were sent to 108 randomized patients with LPC and to an age-matched control group (n = 68). Mean age was 72 years. Mean total dose was 65 grays (Gy; 62.3-70 Gy). The median follow-up time from randomization was 40.6 months for the RT group and 30.4 months for the DT group.

    RESULTS: Social functioning was the only QOL scale in which a significant difference was found between the two patient groups and compared with the control group. Multivariate regression analysis showed that hematuria, incontinence, mucus, and planning of daily activities in response to intestinal problems caused this decrease in QOL in the RT group. A significant increase of intestinal problems was observed in the RT versus DT groups regarding mucus, stool leakage, intestinal blood, and planning of daily activity in response to intestinal problems.

    CONCLUSIONS: The RT patients showed increased levels of minor intestinal side effects compared with the DT patients and the controls, but the RT patients reported no decreased QOL except for decreased social functioning. This could be because this group developed coping skills or because of a low magnitude of side effects to influence the QOL.

  • 13.
    Fransson, Per
    et al.
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Damber, Jan-Erik
    Widmark, Anders
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Health-related quality of life 10 years after external beam radiotherapy or watchful waiting in patients with localized prostate cancer2009In: Scandinavian Journal of Urology and Nephrology, ISSN 0036-5599, E-ISSN 1651-2065, Vol. 43, no 2, p. 119-126Article in journal (Refereed)
    Abstract [en]

    Objective. To evaluate long-term randomized comparisons of patient-reported outcome of symptoms and health-related quality of life (HRQoL) in men with localized prostate cancer 10 years after external beam radiotherapy (RT) or watchful waiting (WW). Material and methods. Three-year HRQoL and specific symptoms in surviving patients recruited between 1986 and 1996 were previously evaluated in a randomized trial; definitive RT versus WW. Two questionnaires were used: the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and the Prostate Cancer Symptom Scale (PCSS). The present study is a prolonged follow-up with the same cohorts. Results. Fifty-four of 72 eligible patients (75%) returned the questionnaires at the present follow-up. The median age was 77 years in the RT group and 78 years in the WW group. The median follow-up time from randomization was 10 years. No differences in HRQoL or bowel symptoms were measured between the RT and WW. Cognitive (RT) and physical function (WW) decreased between 4 years and 10years. Weak urinary stream differed between the RT and WW groups. Fatigue and nocturia were increased in the RT group, and erections decreased in the WW patients over time. No difference in erectile function was seen between the RT and WW groups (p=0.292). Conclusion. The pattern of urinary and bowel symptoms and sexual function was rather similar, independent of RT or WW. Treatment with RT had minimal influence on HRQoL, in comparison with that of WW, at 10-year follow-up.

  • 14.
    Fransson, Per
    et al.
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Lund, Jo-Asmund
    Damber, Jan-Erik
    Klepp, Olbjörn
    Wiklund, Fredrik
    Fosså, Sophie
    Widmark, Anders
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Quality of life in patients with locally advanced prostate cancer given endocrine treatment with or without radiotherapy: 4-year follow-up of SPCG-7/SFUO-3, an open-label, randomised, phase III trial.2009In: The Lancet Oncology, ISSN 1470-2045, E-ISSN 1474-5488, Vol. 10, no 4, p. 370-380Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Androgen treatment for prostate cancer can adversely affect functional domains of quality of life. We aimed to assess quality of life in men with locally advanced prostate cancer in an open-label phase III randomised comparison between lifelong endocrine treatment with and without radiotherapy.

    METHODS: We obtained quality-of-life information from 872 (99%) of 875 eligible men with locally advanced prostate cancer (T3; 78%) who were randomly assigned, between 1996 and 2002, to 3 months of total androgen blockade followed by continuous endocrine treatment (439 patients) or the same hormonal treatment with radiotherapy 3 months after randomisation (436 patients). Prospective outcomes included patient-reported symptoms and quality of life assessed with questionnaires from baseline to 4 years after randomisation. Analysis was by intention to treat. This study is registered as an international standard randomised controlled trial, number ISRCTN01534787.

    FINDINGS: 438 of 439 men assigned endocrine treatment and 434 of 436 assigned endocrine plus radiotherapy completed at least one questionnaire. Missing data at baseline and during follow-up was equally distributed between groups. At 4 years, 64 (18%) of 353 patients on combined therapy and 39 (12%) of 337 on endocrine-alone therapy had moderate to severe urinary bother (p=0.005), and 16 (4%) of 355 on combined therapy and five (2%) of 338 on endocrine treatment alone had pain while urinating (p=0.024). 37 (11%) of 350 in the combined group and 23 (7%) of 35 in the endocrine-only group had overall bother from all bowel symptoms (p=0.022). 281 (85%) of 332 in the combined-treatment group and 227 (72%) of 313 in the endocrine-only group had erectile dysfunction (p=0.0002). Quality of life at 4 years was similar, with the exception of decreased social function in patients receiving endocrine treatment plus radiotherapy.

    INTERPRETATION: Although addition of radiotherapy to endocrine treatment significantly increased some treatment-related symptoms, none were serious. Given the substantial survival benefit of combined treatment, the increase of symptoms seems acceptable and has little extra effect on quality of life after 4 years compared with endocrine treatment alone.

  • 15.
    Fransson, Per
    et al.
    Umeå University, Faculty of Medicine, Department of Nursing.
    Olofsson, Sebastian
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Widmark, Anders
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Thellenberg Karlsson, Camilla
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Patient-reported gastrointestinal and genitourinary toxicity after prostate cancer treatment: A comparison between radiotherapy including pelvic nodes and prostate-only radiotherapy2015In: Journal of Clinical Oncology, ISSN 0732-183X, E-ISSN 1527-7755, Vol. 33, no 7 SArticle in journal (Other academic)
    Abstract [en]

    Background: To evaluate side effects of radiotherapy (RT) including the pelvic nodes in patients with prostate cancer. Methods: 143 patients with high risk prostate cancer (Pca) receiving whole pelvic radiotherapy (WPRT) was matched to a group of 142 patients receiving RT towards the prostate and seminal vesicles only (PORT). Both groups were given 78 Gy towards the prostate and 50 Gy towards the seminal vesicles. The WPRT group also received 50 Gy towards the pelvic nodes. WPRT was given with intensity modulated RT or volumetric modulated arc therapy technique and the group treated towards the prostate and seminal vesicles only was treated with 3-dimensional conformal RT. Gastrointestinal (GI) and genitourinary (GU) side effects were evaluated with patient-reported questionnaires and with the RTOG scale, scored by treating physician, at baseline and one-year after RT. Results: Overall the side effects were mild. At one-year follow up there were significant differences regarding morning urgency, mucus- and blood in stool between the two groups (Table 1). The WPRT group expressed lesser complications in all of these cases. In the RTOG GU and GI scores there were no differences between the groups. About 20% had RTOG grade 2 GU score and 2%/1% had RTOG grade 3 score in the PORT and WPRT groups, respectively. The numbers for RTOG grade 2 GI scores were 11% and 5% in the PORT and WPRT groups, respectively. None of the groups reported RTOG grade 3 GI symptoms. Conclusions: Whole pelvic RT can be done with a very satisfying profile of side effects. Sometimes even lesser gastrointestinal reported side effects are seen with the newer techniques compared to prostate only radiotherapy with older techniques.

  • 16.
    Fransson, Per
    et al.
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Tavelin, Björn
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Widmark, Anders
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Reliability and responsiveness of a prostate cancer questionnaire for radiotherapy-induced side effects2001In: Supportive Care in Cancer, ISSN 0941-4355, E-ISSN 1433-7339, Vol. 9, no 3, p. 187-198Article in journal (Refereed)
    Abstract [en]

    Few self-assessment cancer-specific questionnaires / modules have yet been developed for radiotherapy-induced side effects. The aim of the present study was to test the reliability and responsiveness of a prostate cancer (PC)specific questionnaire. Thirty-one patients with PC graded their urinary and intestinal symptoms and their sexual function on the questionnaire. A doctor and a nurse performed a structured interview and graded the patient's symptoms with the same questions. The procedure was performed at both the start and the end of the treatment. A high concordance regarding symptom detection was seen between the patient, nurse and the doctor. The inter-rater test shows intraclass correlation coefficient (ICC) values above 0.60 in all scales. The internal reliability exceeded the lower limit (Cronbach alpha > 0.70) for all scales. The test-retest gave acceptable reliability for all scales (ICC greater than or equal to 0.60). All scales indicated increased problems during radiotherapy. The questionnaire was proven to be valid for the evaluations of urinary and intestinal problems and for sexual function in PC patients.

  • 17.
    Fransson, Per
    et al.
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Widmark, Anders
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    15-year prospective follow-up of patient-reported outcomes of late bowel toxicity after external beam radiotherapy for localized prostate cancer. A comparison with age-matched controls2007In: Acta Oncologica, ISSN 0284-186X, E-ISSN 1651-226X, Vol. 46, no 4, p. 517-524Article in journal (Refereed)
    Abstract [en]

    We have previously described patient-reported outcomes of late side effects induced by conventional external beam radiotherapy (EBRT), 4 and 8 years after treatment, in 181 patients with localized prostate cancer compared with 141 age-matched controls. In the present study, we compare bowel side effects 15 years after EBRT with the same controls, and with the results of our previous 4-year and 8-year follow-ups. Of the 181 patients and 141 controls at the 4-year follow-up, 45 patients (25%) and 79 controls (56%) were still alive at the 15-year follow-up. Bowel symptoms were assessed using the symptom-specific questionnaire Prostate Cancer Symptom Scale (PCSS), which was sent to these 45 patients and 79 age-matched controls with a mean follow-up time of 15 years (162–197 months) after EBRT. The answer frequency was 64% in the patient group and 52% in the control group. The mean age was 78 years in both groups. At the 15-year follow-up, 39% of the patients and 84% of the controls reported no bowel problems (p <0.001), while 16% of the patients and 0% of the controls reported “Quite a few/many” problems with mucus in the stools (p <0.001). “Quite a bit/much” stool leakage was reported by 20% of the patients at the 15-year follow-up, in comparison to 4% of the patients at the 4-year follow-up (ns). The proportion of patients reporting late bowel symptoms was unchanged 15 years after EBRT in comparison to the 4-year follow-up. Increased bowel symptoms were seen in patients in comparison to the age-matched controls.

  • 18.
    Fransson, Per
    et al.
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Widmark, Anders
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Does one have a sexual life 15 years after external beam radiotherapy for prostate cancer? Prospective patient-reported outcome of sexual function comparison with age-matched controls2011In: Urologic Oncology, ISSN 1078-1439, E-ISSN 1873-2496, Vol. 29, no 2, p. 137-144Article in journal (Refereed)
    Abstract [en]

    Background and purpose: We previously published research on 4- and 8-year follow-ups of patient-reported sexual function after conventional external beam radiotherapy (EBRT) for localized prostate cancer (LPC) compared with age-matched controls. The current study is a prolonged 15-year follow-up with the same cohorts.

    Material and methods: The cohort consisted of 29 men surviving from a group of 181 men treated between 1986 and 1989, and who were reported on previously. Of the originally reported 141 controls, 62 were eligible and 34 completed the questionnaires. Sexual function was assessed using two questionnaires, Prostate Cancer Symptom Scale (PCSS) and International Index of Erectile Function (IIEF-5).

    Results: Twenty-three patients (78%) and 13 controls (38%) were not sexually active. None of the patients and 14 controls had enough of an erection to perform intercourse. Seventeen patients (94%) and 14 controls (64%) had severe erectile dysfunction. Patients with clinical progression and who had received hormone treatment had decreased sexual desire. No significant differences were measured between patients without progression/hormone treatment and the controls.

    Conclusion: The sexual activity 15 years after EBRT for LPC was very low, as was the probability of achieving an erection. Patients with a progressive disease and treated with hormones reported worse sexual and erectile function. The LPC free men showed higher sexual activity, lower sexual bother, and better erectile function than the patients.

  • 19.
    Fransson, Per
    et al.
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology. Umeå University, Faculty of Medicine, Department of Nursing.
    Widmark, Anders
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Late side effects unchanged 4-8 years after radiotherapy for prostate carcinoma: A comparison with age-matched controls1999In: Cancer, ISSN 0008-543X, E-ISSN 1097-0142, Vol. 85, no 3, p. 678-688Article in journal (Refereed)
    Abstract [en]

    BACKGROUND. The authors of this study previously evaluated pelvic irradiation-induced late side effects in patients with localized prostatic carcinoma 4 years after external irradiation by administering a validated self-assessment questionnaire (QUFW94), and compared the results with those of age-matched controls. The current study was designed to evaluate prospectively the patients' problems 8 years after radiotherapy and to compare them with those reported by the same controls. METHODS. The questionnaire was sent out at a mean of 8 years (range, 72-104 months) after irradiation to 120 patients and 125 controls. For analysis of sexual function, the patient group was divided into two subgroups, one treated with radiotherapy only (RT) and one group treated with radiotherapy plus castration (RT+A). A value of >1 on a 0-10 scale indicated that the patient was having a problem. RESULTS, The mean age was 73 years for both patients and controls. No changes in urinary problems were seen between the 4-year and the 8-year follow-up in the 2 groups. Sixty percent and 54% of the patients (P = 0.096) and 24% and 31% of the controls (P = 0.988) reported urinary problems at the 4-year and 8-year follow-ups, respectively. No changes in gastrointestinal late side effects in the patient group were seen between the 4-year (65%) and the 8-year (62%) follow-ups (P = 0.490). However, there was a decrease in intestinal problems in the control group between the 4-year (12%) and the 8-year (9%) follow-ups (P = 0.001). The sexual problems did not change during the two periods, in the patient groups or in the control groups. Fifty-six percent and 65% of the RT group (P = 0.052), 67% and 54% of the RT + A group (P = 0.555), and 27% and 33% of the control group (P = 0.243) indicated some kind of sexual problem at the 4-year and 8-year follow-ups, respectively. CONCLUSIONS. The amount of pelvic irradiation-induced urinary late side effects, intestinal late side effects, and sexual function, evaluated with a self-assessment questionnaire, did not change between 4 and 8 years after RT. The age-matched controls reported no change in urinary or sexual problems despite advanced age, but there was a reported decrease in intestinal problems, Cancer 1999;85:678-88. (C) 1999 American Cancer Society.

  • 20.
    Fransson, Per
    et al.
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Widmark, Anders
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Self-assessed sexual function after pelvic irradiation for prostate carcinoma: Comparison with an age-matched control group1996In: Cancer, ISSN 0008-543X, E-ISSN 1097-0142, Vol. 78, no 5, p. 1066-1078Article in journal (Refereed)
    Abstract [en]

    BACKGROUND. Treatment of localized prostate carcinoma is often accompanied by disturbances in sexual function. The patient's own opinion and experience with these problems can be of great importance for his quality of life. In men older than 50 years, disturbances in sexual function are common. Treatment such as radiotherapy (RT), which can induce sexual dysfunction, should be evaluated in relation to the problems in an age-matched population without prostate carcinoma. METHODS. Sexual function was evaluated with a self-assessment questionnaire using linear-analogue scales. The questionnaire was sent to 199 patients with prostate carcinoma, median age 71 years (range, 51-86 years), who had received pelvic RT with curative intent and to 200 age-matched men in northern Sweden. Mean follow-up time after RT was 48 months (range, 24-56 months). RESULTS. The response rate was high: 141 (71%) and 181 (91%) in the control and patient groups, respectively. Field reduction and treatment pause during RT was not associated with decreased problems in the patient groups. A failure to achieve erection was indicated in 12% of the control subjects, 56% of the patients who had received (RT only) and 87% of the RT + castration (RT + A) patients. In general, patients < 70 years treated with RT + A indicated more sexual problems than the RT only patients < 70 years. There was a strong negative correlation between age and sexual problems in the RT 9 A < 70 years group. However, in patients < 70 years, sexual activity after RT only, was not significantly different from the age-matched control population. CONCLUSIONS. Patients with prostate carcinoma treated with RT only indicated higher levels of sexual dysfunction than age-matched controls. This was most obvious in patients younger than 70 years, although their sexual activity was comparable to age-matched controls. The addition of castration to RT tended to increase sexual problems, especially in patients < 70 years. In men between 70 and 74 years, the maintenance of sexual function seems to be very susceptible to disturbances. For patients older than 74 years, decreased sexual function was not perceived as such a significant problem, despite abolished desire and erection. (C) 1996 American Cancer Society.

  • 21.
    Hajdarevic, Senada
    et al.
    Umeå University, Faculty of Medicine, Department of Nursing.
    Rasmussen, Birgit H
    Department of Health Sciences, Lund University, Lund, Sweden.
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Nursing.
    You Need to Know More to Understand My Scoring on the Survey: Free-Text Comments as Part of a PROM-Survey of Men with Prostate Cancer2016In: Open Journal of Nursing, ISSN 2162-5336, E-ISSN 2162-5344, Vol. 6, no 5, p. 365-375Article in journal (Refereed)
    Abstract [en]

    Prostate cancer and its treatment have long-term implications for men's lives. We aimed to describe the content, extent, and frequency of written comments to the open-ended question, "Further comments?" in the patient-reported outcome measures questionnaire. During the study period, 897 men participated; 372 wrote 747 free-text comments in the questionnaire. These comments were analysed using qualitative content analysis and were grouped into four categories: 1) prostate cancer's influence on health; 2) clarifications of answers to the survey; 3) descriptions of well-being despite the cancer; and 4) experiences of care and the need for contact with health care. The distribution of the comments shifted over time. The open-ended question not only allowed the participants to explain their other responses and describe important aspects of their lives during and after treatment, something not normally covered by a questionnaire, but it also indicated their experiences of health care services along the patients' PC-trajectory. This further raises the issue of including an open-ended item in a forced-choice survey into the ethical realm to ensure that proper care is taken of participants’ answers and thoughts.

  • 22. Holm, Maja
    et al.
    Doveson, Sandra
    Lindqvist, Olav
    Umeå University, Faculty of Medicine, Department of Nursing. Department of Learning, Informatics, Management & Ethics, Karolinska Institutet, Sweden.
    Wennman-Larsen, Agneta
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Nursing.
    Quality of life in men with metastatic prostate cancer in their final years before death: a retrospective analysis of prospective data2018In: BMC Palliative Care, ISSN 1472-684X, E-ISSN 1472-684X, Vol. 17, article id 126Article in journal (Refereed)
    Abstract [en]

    Background: Quality of Life (QoL) is the most important outcome for patients in palliative care along with symptom alleviation. Metastatic prostate cancer (mPC) is a life-threatening illness, and hence, a palliative care approach may be beneficial to this group. Over time, new life-prolonging treatments have been developed for men with mPC, but the possibility to prolong life should also be balanced against the men’s QoL, particularly because there are side effects involved with these treatments. The aim of this study was to evaluate QoL, functioning and symptoms in men with mPC during their final years before death.

    Methods: This is a retrospective analysis of data from a long-term prospective study of men (n = 3885) with prostate cancer from two regions in Sweden. Validated questionnaires asking about participants’ QoL, functioning and symptoms were used to collect data. From the overall study, 190 men with mPC were identified. They were stratified into three groups, depending on the amount of time that had passed between the last questionnaire and their death; < 6 months, 6–18 months and > 18 months before death.

    Results: Men with mPC generally rated their QoL poorly compared to established clinically significant threshold values. The group of men that were < 6 months before death rated their QoL, functioning and several symptoms significantly worse than the two other groups. Men that died after the year 2006 reported lower QoL and functioning and more pain and fatigue than those who died before 2006.

    Conclusion: The results in this study indicate that men with mPC have unmet needs with regards to QoL and symptoms. A palliative care approach, alongside possible life-prolonging treatments, that focuses on QoL and symptom relief, may serve as an important frame to give the best support to these men in their final years of life.

  • 23.
    Isaksson, Joakim
    et al.
    Umeå University, Faculty of Social Sciences, Department of Social Work.
    Wilms, Torben
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Otorhinolaryngology. Umeå University, Faculty of Medicine, Department of Medical Biosciences, Pathology.
    Laurell, Göran
    Institutionen för kirurgiska vetenskaper, Öron-, näs- och halssjukdomar, Uppsala universitet.
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Nursing.
    Tiblom Ehrsson, Ylva
    Institutionen för kirurgiska vetenskaper, Öron-, näs- och halssjukdomar, Uppsala universitet.
    Meaning of work and the process of returning after head and neck cancer2016In: Supportive Care in Cancer, ISSN 0941-4355, E-ISSN 1433-7339, Vol. 24, no 1, p. 205-213Article in journal (Refereed)
    Abstract [en]

    Purpose: The purposes of this study were (1) to investigate employment status at diagnosis, sick leave, and returning to work patterns in correlation to quality of life, anxiety, and depression in patients treated for head and neck cancer (HNC) and (2) to explore patients' experiences of the process of returning to work.

    Methods: Sixty-six patients with HNC (aged 34-66 years) were repeatedly interviewed over a period of 24 months. Interview responses that concerned the patients' experiences and ideas about work were categorised using the similarities-differences technique. Questionnaires on quality of life, anxiety, and depression were used to describe the patient characteristics and the differences between groups.

    Results: In total, 53 % of the patients had returned to work at 24 months after treatment, and 17 % were deceased. Several quality of life parameters were significantly worse for patients not working at 24 months after treatment. Nine categories were found to describe the return-to-work-process starting with symptoms causing sick leave, thoughts about the sick leave, and ending with the return to work and/or retirement.

    Conclusions: Returning to work is an important part of life because it structures everyday life and strengthens the individual's identity. The quality of life results showed significant differences between workers and non-workers at the 24 month follow-up. The patients need to be both physically and mentally prepared for the process of returning to work. It is important to take an individual rehabilitation approach to guide and support the patients in returning to work and regaining an important aspect of their everyday life. In such an approach, it is vital to understand the patients' overall life context and the patients' own perspective on the process and meaning associated with work.

  • 24. Jakobsson, Liselotte
    et al.
    Fransson, Per
    School of Health and Society, Kristianstad University, SE-291 88 Kristianstad, Sweden.
    Patient Reported Outcome Measure (PROM) of quality of life after prostatectomy: results from a 5-year study2013In: The open nursing journal, ISSN 1874-4346, Vol. 7, p. 165-173Article in journal (Refereed)
    Abstract [en]

    Prostate cancer is the most common cancer among men in Sweden, and treatment is negatively affecting the patients' quality of life. Even so, long term experiences are sparse and implications for nursing practice are little known. The aim of this study was to determine areas of functioning and factors impacting quality of life, QOL, during and five years after radical prostatectomy (RP) using a quality of life questionnaire and a specific module for prostate cancer. A longitudinal study was performed with consecutively included Swedish men from baseline and after RP treatment (n=222) from 2003 to 2011 to obtain their opinions on quality of life. Data was gathered through a mail out - mail in procedure at baseline, 3 months, 1-3 and 5 years after treatment with a response rate of 94.14% - 75.2%. One reminder was sent on each occasion. Identified areas with increased functioning after five years were emotional and social functioning. QOL ratings did not change over the years. Sexual activity and functioning decreased and hormonal treatment-related symptoms increased. Impact on QOL was found regarding emotional and social functioning, nausea/vomiting, pain and hormone-related symptoms. Increasing age, living with a partner and educational level had no significant impact on QOL. Implications for nursing are to initially focus on physical problems and at times for follow-up visits pay attention also to emotional and social aspects of life. To be able to make a difference in the patient's life, nurses need to bridge the gap between in-hospital treatment and everyday life outside hospital.

  • 25. Langegård, Ulrica
    et al.
    Ahlberg, Karin
    Björk-Eriksson, Thomas
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Nursing. Department of Cancercentrum, Norrlands University Hospital, Umeå.
    Johansson, Birgitta
    Ohlsson-Nevo, Emma
    Witt-Nyström, Petra
    Sjövall, Katarina
    The art of living with symptoms: a qualitative study among patients with primary brain tumors receiving proton beam therapy2019In: Cancer Nursing, ISSN 0162-220X, E-ISSN 1538-9804Article in journal (Refereed)
    Abstract [en]

    Background: Symptom management in conjunction with proton beam therapy (PBT) from patient's perspective has not been explored. Such knowledge is essential to optimize the care in this relatively new treatment modality.

    Objective: The aim of this study was to explore the process of symptom management in patients with brain tumor receiving PBT.

    Methods: Participants were 22 patients with primary brain tumor who received PBT, recruited in collaboration with a national center for proton therapy and 2 oncology clinics at 2 university hospitals in Sweden. Interviews using open-ended questions were conducted before, during, and/or after treatment. Verbatim interview transcripts were analyzed using classic Grounded Theory.

    Results: The art of living with symptoms” emerged as the core concept. This encompassed 3 interconnected symptom management concepts: “Adapting to limited ability,” “Learning about oneself,” and “Creating new routines.” These concepts were summarized in a substantive theoretical model of symptom management. Despite the struggle to manage symptoms, participants lived a satisfactory life.

    Conclusions: Symptom management in conjunction with PBT comprises a process of action, thoughts, and emotions. The concepts that emerged indicated patients' symptom management strategies were based on their own resources.

    Implications for Practice: It is important that PBT facilities develop an approach that facilitates the symptom management process based on patients' experiences of symptoms, as well as their actions and available resources.

  • 26. Langegård, Ulrica
    et al.
    Ahlberg, Karin
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Nursing. Cancercentrum, Norrlands University Hospital, Umeå, Sweden.
    Johansson, Birgitta
    Sjövall, Katarina
    Bjork-Eriksson, Thomas
    Ohlsson-Nevo, Emma
    Evaluation of quality of care in relation to health-related quality of life of patients diagnosed with brain tumor: a novel clinic for proton beam therapy2019In: Supportive Care in Cancer, ISSN 0941-4355, E-ISSN 1433-7339, Vol. 27, no 7, p. 2679-2691Article in journal (Refereed)
    Abstract [en]

    PURPOSE: Patients with brain tumors constitute a vulnerable group, and it is important that they receive the highest quality of care (QoC). The study aim was to describe the perceptions of QoC and its association with health-related quality of life in brain tumor patients undergoing proton beam therapy in a newly established clinic.

    METHOD: Data were collected at the start of treatment and after 3 and 6 weeks. Adult patients (≥ 18 years old) with brain tumors (n = 186) completed two self-administered questionnaires: a modified Quality from the Patients' Perspective, which measures perceived reality and subjective importance of care, and the EORTC QLQ-C30. Data were analyzed using parametric and non-parametric statistical tests.

    RESULTS: The perceived QoC was highest for treatment information and lowest for dietician and smoking information, whereas interaction with doctors and nurses was rated as the most important aspect of quality of care. Subjective importance ratings were significantly higher than perceived reality ratings for 60% of items. A better global health was moderately correlated with a higher perceived support for fatigue.

    CONCLUSIONS: A need for quality improvement was identified for several aspects of patient care. Greater symptom distress during the treatment period led to greater perceived importance of symptom support. Ensuring QoC is complex and collaboration with other health care professionals is essential.

    RELEVANCE TO CLINICAL PRACTICE: The clinic could improve QoC regarding information about possible symptoms, adjust care according to patient perceptions of importance, and involve patients in care decisions.

  • 27. Langegård, Ulrica
    et al.
    Johansson, Birgitta
    Bjork-Eriksson, Thomas
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Nursing.
    Ohlsson-Nevo, Emma
    Sjövall, Katarina
    Ahlberg, Karin
    Symptom Clusters in Patients With Brain Tumors Undergoing Proton Beam Therapy2019In: Oncology Nursing Forum, ISSN 0190-535X, E-ISSN 1538-0688, Vol. 46, no 3, p. 349-363Article in journal (Refereed)
    Abstract [en]

    OBJECTIVES: To explore symptom clusters during proton beam therapy in patients with primary brain tumors and investigate associations among symptom clusters, demographic variables, and comorbidity in this patient population.

    SAMPLE & SETTING: Data were collected from 187 adult patients with primary brain tumors during their treatment periods in the Skandion Clinic in Uppsala, Sweden. Symptoms were assessed with the Radiotherapy-Related Symptoms Assessment Scale, and comorbidity was evaluated with the Self-Administered Comorbidity Questionnaire.

    METHODS & VARIABLES: The study used a quantitative and longitudinal design. Exploratory factor analysis was used to determine the underlying structure of symptom clusters.

    RESULTS: Three clusters were identified.

    IMPLICATIONS FOR NURSING: Building knowledge about how these symptoms interact and are clustered will support healthcare professionals to more efficiently relieve symptom clusters during proton beam therapy.

  • 28.
    Lehuluante, Abraraw
    et al.
    Umeå University, Faculty of Medicine, Department of Nursing.
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Nursing.
    Are there specific health-related factors that can accentuate the risk of suicide among men with prostate cancer?2014In: Supportive Care in Cancer, ISSN 0941-4355, E-ISSN 1433-7339, Vol. 22, no 6, p. 1673-1678Article in journal (Refereed)
    Abstract [en]

    PURPOSE: The aim of this study was to explore if there were some specific factors pertinent to health-related quality of life (HRQoL) that could affect self-experienced suicide ideation in men with prostate cancer (PCa).

    METHODS: Questionnaires containing 45 items were distributed to members of the Swedish Prostate Cancer Federation in May 2012. Out of 6,400 distributed questionnaires, 3,165 members (50 %) with PCa completed the questionnaires. Those members expressed their experienced HRQoL and experienced suicide ideation using VAS-like scales as well as multiple-choice questions. Both descriptive and analytical statistical methods were employed. A regression model was used to explore the relationship between experienced health-related quality of life and experienced suicide ideation.

    RESULTS: Generally, the respondents rated their self-experienced health-related quality of life as good. About 40 % of the participants had experienced problem with incontinence, and 23 % had obstructions during miction. About 7 % of the respondents experienced suicidal ideation, at least sometime. The regression model showed statistically significant relationships between suicide ideation, on the one hand, and lower self-rated health-related quality of life (P < 0.001), physical pain (P = 0.04), pain during miction (P = 0.03), and low-rated mental / physical energy (P = 0.03), on the other.

    CONCLUSION: It is quite necessary to know which specific disease and treatment-related problems can trigger suicide ideations in men with prostate cancer and to try to direct treatment, care, and psychosocial resources to alleviate these problems in time.

  • 29. Lund, Jo-Å
    et al.
    Kaasa, Stein
    Wibe, Arne
    Widmark, Anders
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Nursing.
    Late radiation effects to the rectum and anus after treatment for prostate cancer; validity of the LENT/SOMA score2013In: Acta Oncologica, ISSN 0284-186X, E-ISSN 1651-226X, Vol. 52, no 4, p. 727-735Article in journal (Refereed)
    Abstract [en]

    Background. The Late Effects Normal Tissue/Subjective Objective Management Analytic (LENT/SOMA) system for grading of side effects after radiotherapy was proposed several years ago. Only a few studies have previously been performed on the validity of the LENT/SOMA. The aim of the present study was to validate the LENT/SOMA scoring system for recto-anal side effects after treatment for prostate cancer in a randomized trial.

    Material and methods. A total of 875 patients with locally advanced prostate cancer were randomized to either hormonal treatment alone or hormonal treatment plus radiotherapy in the Scandinavian Prostate Cancer Group 7 (SPCG-7) study. At least three years after treatment was started, the 178 patients that were randomized at St. Olavs Hospital were approached. One hundred and three patients of these accepted inclusion. The side effects according to LENT/SOMA were graded by oncologist and nurse. In addition, side effects were graded according to the European Organisation for Research and Treatment of Cancer and the Radiation Therapy Oncology Group (EORTC/RTOG) toxicity scale and patient-reported health-related quality of life (HRQOL) questionnaires. Content/face validity, sensitivity and inter-rater reliability of the LENT/SOMA tables for rectum were analyzed.

    Results. Content/face analysis of LENT/SOMA revealed serious problems. Significant correlations (Spearman's rho > 0.4) were found between three of 15 LENT/SOMA items and similar HRQOL items. LENT/SOMA score made it possible to detect significant differences between the two groups of patients (p < 0.001), EORTC/RTOG toxicity score did not (p = 0.138). Inter-rater reliability was acceptable.

    Conclusions. LENT/SOMA scoring system for recto-anal side effects after radiotherapy for prostate cancer displays serious difficulties in the present study. Replacement of LENT/SOMA tables for rectum by a combination of patient-reported HRQOL questionnaires, clinical examination and objective physiological measurements might be called for.

  • 30.
    Nyqvist, Johanna
    et al.
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Otorhinolaryngology. Department of Otolaryngology and Head and Neck Surgery, Skåne University Hospital, Lund.
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Nursing.
    Laurell, Göran
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Otorhinolaryngology. Department of Otolaryngology and Head and Neck Surgery, Uppsala University Hospital.
    Hammerlid, Eva
    Kjellén, Elisabeth
    Franzén, Lars
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Söderström, Karin
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Wickart-Johansson, Gun
    Friesland, Signe
    Sjödin, Helena
    Brun, Eva
    Ask, Anders
    Nilsson, Per
    Ekberg, Lars
    Björk-Eriksson, Thomas
    Nyman, Jan
    Lödén, Britta
    Lewin, Freddi
    Reizenstein, Johan
    Lundin, Erik
    Zackrisson, Björn
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Differences in health related quality of life in the randomised ARTSCAN study; accelerated vs. conventional radiotherapy for head and neck cancer: A five year follow up2016In: Radiotherapy and Oncology, ISSN 0167-8140, E-ISSN 1879-0887, Vol. 118, no 2, p. 335-341Article in journal (Refereed)
    Abstract [en]

    Background and purpose: Health related quality of life (HRQoL) was assessed in the randomised, prospective ARTSCAN study comparing conventional radiotherapy (CF) with accelerated radiotherapy (AF) for head and neck cancer.

    Material and methods: 750 patients with squamous cell carcinoma (of any grade and stage) in the oral cavity, oro-, or hypopharynx or larynx (except T1-2, NO glottic carcinoma) without distant metastases were randomised to either conventional fractionation (2 Gy/day, 5 days/week in 49 days, total dose 68 Gy) or accelerated fractionation (1.1 + 2.0 Gy/day, 5 days/week in 35 days, total dose 68 Gy). HRQoL was assessed with EORTC QLQ-C30, QLQ-H&N35 and HADS at baseline, at end of radiotherapy (eRT) and at 3 and 6 months and 1, 2 and 5 years after start of treatment.

    Results: The AF group reported HRQoL was significantly lower at eRT and at 3 months for most symptoms, scales and functions. Few significant differences were noted between the groups at 6 months and 5 years. Scores related to functional oral intake never reached baseline.

    Conclusion: In comparison to CF, AF has a stronger adverse effect on HRQoL in the acute phase.

  • 31. Plym, Anna
    et al.
    Folkvaljon, Yasin
    Garmo, Hans
    Holmberg, Lars
    Johansson, Eva
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Nursing.
    Stattin, Pär
    Umeå University, Faculty of Medicine, Department of Surgical and Perioperative Sciences, Urology and Andrology.
    Lambe, Mats
    Drug Prescription for Erectile Dysfunction Before and After Diagnosis of Localized Prostate Cancer2014In: Journal of Sexual Medicine, ISSN 1743-6095, E-ISSN 1743-6109, Vol. 11, no 8, p. 2100-2108Article in journal (Refereed)
    Abstract [en]

    Introduction: Despite the high prevalence of erectile dysfunction (ED) in men with prostate cancer, little is known about the use of ED drugs. Also, the possible influence of socioeconomic factors on ED drug use has not been studied previously.

    Aim: The aim of this study was to examine determinants and patterns of ED drug use before and after diagnosis in men with localized prostate cancer.

    Methods: Using a nationwide population‐based cohort, 25,390 men with localized prostate cancer diagnosed between 2006 and 2009 and 126,944 control men were identified and followed for filled ED drug prescriptions over a 3‐year period, ranging from 1 year before and up to 2 years after diagnosis.

    Main Outcome Measures: The main outcome measure was the proportion of men with at least one filled ED drug prescription after diagnosis.

    Results: The number of men using ED drugs increased markedly following diagnosis. Men who underwent radical prostatectomy had the strongest increase, with a cumulative proportion of 74% for at least one filled prescription within the first 2 years after diagnosis. The corresponding proportion was 33% in men treated with radiotherapy, 21% in men on active surveillance, 10% in men on watchful waiting, and 8% in control men. Among men who underwent prostatectomy, usage attenuated over time. Determinants of postdiagnostic use were young age at diagnosis, high income, high education, and a low‐ or intermediate‐risk cancer.

    Conclusion: Although drugs for ED are commonly prescribed after diagnosis, use among most men is transient and influenced by socioeconomic status. Posttreatment counseling and affordable ED drugs are likely to reduce treatment dropout and disparities in use and help improve sexual health and quality of life in men with prostate cancer.

  • 32. Rasmusson, E.
    et al.
    Gunnlaugsson, A.
    Wieslander, E.
    Hoglund, P.
    Widmark, Anders
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Nursing.
    Kjellen, E.
    Nilsson, P.
    Erectile Dysfunction and Absorbed Dose to Penile Base Structures in a Randomized Trial Comparing Ultrahypofractionated and Conventionally Fractionated Radiotherapy for Prostate Cancer2019In: International Journal of Radiation Oncology, Biology, Physics, ISSN 0360-3016, E-ISSN 1879-355X, Vol. 105, no 1, p. S133-S134Article in journal (Refereed)
  • 33. Rasmusson, Elisabeth
    et al.
    Gunnlaugsson, Adalsteinn
    Kjellén, Elisabeth
    Nilsson, Per
    Einarsdottir, Margret
    Wieslander, Elinore
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Nursing.
    Ahlgen, Göran
    Blom, René
    Low-dose rate brachytherapy with I-125 seeds has an excellent 5-year outcome with few side effects in patients with low-risk prostate cancer2016In: Acta Oncologica, ISSN 0284-186X, E-ISSN 1651-226X, Vol. 55, no 8, p. 1016-1021Article in journal (Refereed)
    Abstract [en]

    Background: Low-dose rate brachytherapy (LDR-BT) has been used in Sweden for more than a decade for treatment of low-risk prostate cancer. This study presents the outcome for patients treated with LDR-BT at a single institution with focus on the association between dose and biochemical failure-free survival (BFFS).

    Methods: In total 195 patients were treated with LDR-BT between 2004 and 2008. The patients were followed systematically for side effects for at least one year. PSA levels were followed regularly from three months and for at least five years. Outcome was analyzed in relation to clinical variables at baseline and to radiotherapy data.

    Results: Kaplan-Meier estimated BFFS at five years was 95.7%. Dose to the prostate in terms of D-90% was significantly associated with BFFS [HR 0.90 (95%CI 0.83-0.96), p=0.002].

    Conclusion: Out data confirmed that absorbed dose is a predictive factor for BFFS for low-risk patients without androgen deprivation therapy. With our treatment routines and dosimetry, a D-90% in the range of 170-180Gy gives excellent outcomes with acceptable toxicity for patients with low-risk prostate cancer.

  • 34. Reidunsdatter, Randi J.
    et al.
    Lund, Jo-AÅmund
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Widmark, Anders
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Fosså, Sophie D
    Kaasa, Stein
    Validation of the intestinal part of the prostate cancer questionnaire "QUFW94": psychometric properties, responsiveness, and content validity2010In: International Journal of Radiation Oncology, Biology, Physics, ISSN 0360-3016, E-ISSN 1879-355X, Vol. 77, no 3, p. 793-804Article in journal (Refereed)
    Abstract [en]

    PURPOSE: Several treatment options are available for patients with prostate cancer. Applicable and valid self-assessment instruments for assessing health-related quality of life (HRQOL) are of paramount importance. The aim of this study was to explore the validity and responsiveness of the intestinal part of the prostate cancer-specific questionnaire QUFW94. METHODS AND MATERIALS: The content of the intestinal part of QUFW94 was examined by evaluation of experienced clinicians and reviewing the literature. The psychometric properties and responsiveness were assessed by analyzing HRQOL data from the randomized study Scandinavian Prostate Cancer Group 7 (SPCG)/Swedish Association for Urological Oncology 3 (SFUO). Subscales were constructed by means of exploratory factor analyses. Internal consistency was assessed by Cronbach's alpha. Responsiveness was investigated by comparing baseline scores with the 4-year posttreatment follow-up. RESULTS: The content validity was found acceptable, but some amendments were proposed. The factor analyses revealed two symptom scales. The first scale comprised five items regarding general stool problems, frequency, incontinence, need to plan toilet visits, and daily activity. Cronbach's alpha at 0.83 indicated acceptable homogeneity. The second scale was less consistent with a Cronbach's alpha at 0.55. The overall responsiveness was found to be very satisfactory. CONCLUSION: Two scales were identified in the bowel dimension of the QUFW94; the first one had good internal consistency. The responsiveness was excellent, and some modifications are suggested to strengthen the content validity.

  • 35. Rönningås, Ulrika
    et al.
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Nursing. Cancercentrum, Norrlands University Hospital, Umeå, Sweden.
    Holm, Maja
    Wennman-Larsen, Agneta
    Prostate-specific antigen (PSA) and distress: a cross-sectional nationwide survey in men with prostate cancer in Sweden2019In: BMC Urology, ISSN 1471-2490, E-ISSN 1471-2490, Vol. 19, article id 66Article in journal (Refereed)
    Abstract [en]

    Background: The prostate-specific antigen (PSA) -value is often used during the prostate cancer trajectory as a marker of progression or response to treatment. Concerns about PSA-values are often expressed by patients in clinical situations. Today there is a lack of larger studies that have investigated the association between PSA-value and distress. The aim was to investigate the association between PSA-values and distress adjusted for sociodemographic factors, hormonal therapy and quality of life (QoL), among men with prostate cancer.

    Methods: In this cross-sectional survey of 3165 men with prostate cancer, members of the Swedish Prostate Cancer Federation, answered questions about sociodemographic factors, PSA, distress, QoL and treatments. Descriptive statistics, and bivariate and multivariable analyses were performed. The result was presented based on four PSA-value groups: 0–19, 20–99, 100–999, and ≥ 1000 ng/ml.

    Results: Of the men, 53% experienced distress. An association between distress and PSA-values was found where higher PSA-values were associated with higher OR:s for experiencing distress in the different PSA-groups: 0–19 ng/ml (ref 1), 20–99 ng/ml (OR 1.25, 95% CI 1.01–1.55), 100–999 ng/ml (OR 1.47, 95% CI 1.12–1.94), ≥1000 ng/ml (OR 1.77, 95% CI 1.11–2.85). These associations were adjusted for sociodemographic factors and hormonal therapy. In the multivariable analyses, beside PSA-values, higher levels of distress were associated with being without partner or hormonal therapy. When adding QoL in the multivariable analysis, the association between PSA and distress did not remain significant.

    Conclusion: These results indicate that the PSA-values are associated with distress, especially for those with higher values. However, to be able to support these men, continued research is needed to gain more knowledge about the mechanisms behind the association between emotional distress and PSA-values.

  • 36. Steinsvik, E Andreas Svaboe
    et al.
    Fosså, Sophie D
    Axcrona, Karol
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Widmark, Anders
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Dahl, Alv A
    Do perceptions of adverse events differ between patients and physicians? Findings from a randomized, controlled trial of radical treatment for prostate cancer2010In: Journal of Urology, ISSN 0022-5347, E-ISSN 1527-3792, Vol. 184, no 2, p. 525-531Article in journal (Refereed)
    Abstract [en]

    PURPOSE: Previous cross-sectional studies show considerable discrepancies between patient and physician ratings of adverse events after prostate cancer treatment. We used data from a randomized, controlled trial to examine such discrepancies.

    MATERIAL AND METHODS: The Scandinavian Prostate Cancer Groups Study 7 randomized men with locally advanced prostate cancer to antiandrogen monotherapy or to the same hormone treatment combined with external beam radiotherapy after 3 months of total androgen blockade. We selected a subsample of 333 men with valid ratings at baseline, and at 12 and 24-month followup for this prospective substudy. We also examined a cross-sectional sample of 305 men at the end of radiotherapy. We compared patient and physician ratings of frequency of daytime and nighttime urination, urinary incontinence, erectile dysfunction, bowel problems, nausea/vomiting, breast tenderness and gynecomastia.

    RESULTS: Perfect agreement between patient and physician ratings was observed in 70% to 100% of cases at baseline, in 73% to 98% at 12 months and in 65% to 97% at 24 months. There were 1% to 20% changes in perfect agreement with time. With patient ratings as the gold standard physicians more often underrated than overrated adverse events, except bowel problems, which were overrated at all posttreatment points.

    CONCLUSIONS: In a randomized, controlled trial of external beam radiotherapy and hormone manipulation physicians recorded pelvis related adverse events in acceptable accordance with their patients with prostate cancer. The oncologist tendency to overestimate bowel problems after radiotherapy needs further investigation. Our positive findings from a formal trial should not be transferred to daily clinical practice without further studies of discrepancies in routine clinical practice.

  • 37. Stranne, J.
    et al.
    Axen, E.
    Franck-Lissbrant, I.
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Nursing.
    Frånlund, M.
    Hugosson, J.
    Khatami, A.
    Koss-Modig, K.
    Lodding, P.
    Nyberg, M.
    Stattin, P.
    Bratt, O.
    Single institution followed by national implementation of systematic surgical quality control and feedback for radical prostatectomy: a 20-year journey2019In: World journal of urology, ISSN 0724-4983, E-ISSN 1433-8726Article in journal (Refereed)
    Abstract [en]

    Purpose: The demand for objective and outcome-based facts about surgical results after radical prostatectomy (RP) is increasing. Systematic feedback is also essential for each surgeon to improve his/her performance.

    Methods: RP outcome data (e.g., pT-stage and margin status) have been registered at Sahlgrenska University Hospital (SUH) since 1988 and patient-related outcome measures (PROM) have been registered since 2001. The National Prostate Cancer Registry (NPCR) has covered all Regions in Sweden since 1998 and includes PROM-data from 2008. Initially PROM was on-paper questionnaires but due since 2018 all PROMs are collected electronically. In 2014 an on-line “dashboard” panel was introduced, showing the results for ten quality-control variables in real-time. Since 2017 all RP data on hospital, regional, and national levels are publicly accessible on-line on “www.npcr.se/RATTEN”.

    Results: The early PROM-data from SUH have been used for internal quality control. As national clinical and PROM-data from the NPCR have been made accessible on-line and in real-time we have incorporated this into our pre-existing protocol. Our data are now internally available as real-time NPCR reports on the individual surgeons’ results, as well as ePROM data. We can compare the results of each surgeon internally and to other departments’ aggregated data. The public can access data and compare hospital level data on “RATTEN”.

    Conclusions: The process of quality control of RP locally at SUH, and nationally through the NPCR, has been long but fruitful. The online design, with direct real-time feedback to the institutions that report the data, is essential.

  • 38. Sveistrup, Joen
    et al.
    Widmark, Anders
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Nursing.
    Iversen, Peter
    Munck Af Rosenschöld, Per
    Engelholm, Svend Aage
    Petersen, Peter Meidahl
    Prospective assessment of urinary, gastrointestinal and sexual symptoms before, during and after image-guided volumetric modulated arc therapy for prostate cancer2015In: Scandinavian journal of urology, ISSN 2168-1805, E-ISSN 2168-1813, Vol. 49, no 1, p. 58-69Article in journal (Refereed)
    Abstract [en]

    Objective: The aim of this study was to prospectively assess the development of 24 urinary, gastrointestinal and sexual symptoms in patients with prostate cancer (PCa) during and after image-guided volumetric modulated arc therapy (IG-VMAT).

    Material and methods: A total of 87 patients with PCa participated in this study. The patients were asked to complete a modified version of the Prostate Cancer Symptom Scale (PCSS) questionnaire before radiotherapy (RT) (baseline), at the start of RT, at the end of RT and 1 year after RT. Changes in symptoms at the start of RT, at the end of RT and 1 year after RT compared to baseline were analysed by a mixed model analysis of repeated measurements with the following covariates: age, comorbidity, smoking and androgen deprivation therapy (ADT).

    Results: All urinary problems except for haematuria increased significantly at the end of RT compared to baseline. One year after RT, there was no longer any difference compared to baseline for any of the urinary symptoms. All gastrointestinal symptoms except for nausea increased significantly at the end of RT. One year after RT, patients also reported slightly higher degrees of stool frequency, bowel leakage, planning of toilet visits, flatulence, mucus, gastrointestinal bleeding and impact of gastrointestinal bother on daily activities compared to baseline. All sexual symptoms increased significantly at all times compared to baseline. The use of ADT was associated with worse sexual symptoms.

    Conclusions: IG-VMAT is a safe treatment for PCa, with few and mild changes in urinary and gastrointestinal symptoms 1 year after RT compared to baseline. Sexual symptoms deteriorated both during and after RT. The use of ADT was associated with worse sexual symptoms.

  • 39. Van Hemelrijck, Mieke
    et al.
    Wigertz, Annette
    Sandin, Fredrik
    Garmo, Hans
    Hellström, Karin
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Nursing.
    Widmark, Anders
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Lambe, Mats
    Adolfsson, Jan
    Varenhorst, Eberhard
    Johansson, Jan-Erik
    Stattin, Pär
    Umeå University, Faculty of Medicine, Department of Surgical and Perioperative Sciences, Urology and Andrology. Department of Surgery, Urology Service, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.
    Cohort Profile: The National Prostate Cancer Register of Sweden and Prostate Cancer data Base Sweden 2.02013In: International Journal of Epidemiology, ISSN 0300-5771, E-ISSN 1464-3685, Vol. 42, no 4, p. 956-967Article in journal (Refereed)
    Abstract [en]

    In 1987, the first Regional Prostate Cancer Register was set up in the South-East health-care region of Sweden. Other health-care regions joined and since 1998 virtually all prostate cancer (PCa) cases are registered in the National Prostate Cancer Register (NPCR) of Sweden to provide data for quality assurance, bench marking and clinical research. NPCR includes data on tumour stage, Gleason score, serum level of prostate-specific antigen (PSA) and primary treatment. In 2008, the NPCR was linked to a number of other population-based registers by use of the personal identity number. This database named Prostate Cancer data Base Sweden (PCBaSe) has now been extended with more cases, longer follow-up and a selection of two control series of men free of PCa at the time of sampling, as well as information on brothers of men diagnosed with PCa, resulting in PCBaSe 2.0. This extension allows for studies with case-control, cohort or longitudinal case-only design on aetiological factors, pharmaceutical prescriptions and assessment of long-term outcomes. The NPCR covers >96% of all incident PCa cases registered by the Swedish Cancer Register, which has an underreporting of <3.7%. The NPCR is used to assess trends in incidence, treatment and outcome of men with PCa. Since the national registers linked to PCBaSe are complete, studies from PCBaSe 2.0 are truly population based.

  • 40.
    Widmark, Anders
    et al.
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Tavelin, Björn
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Self-assessment questionnaire for evaluating urinary and intestinal late side effects after pelvic radiotherapy in patients with prostate cancer compared with an age-matched control population1994In: Cancer, ISSN 1097-0142, Vol. 74, no 9, p. 2520-2532Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Pelvic irradiation to patients with prostate cancer is accompanied by urinary and intestinal reactions. In men older than 60 years, treatment-induced problems should be evaluated in relation to problems in an age-matched nonirradiated population.

    METHODS: In the present study, problems in the urinary tract and intestine were evaluated with a self-assessment questionnaire using the linear-analogue scale. The questionnaire was mailed out to 200 patients and to an age-matched population 24-56 months after irradiation.

    RESULTS: Twenty-five percent of the control group and 50% of the patient group reported some kind of problem in the urinary tract. The most common urinary problems in the control group and in the patient group, respectively, were urgency (19 and 42%), starting problems (22 and 33%), and leakage (11 and 32%). In the control and patient groups, 14 and 59%, respectively, reported some kind of gastrointestinal problems. The most common intestinal problems in the control and patient groups were respectively, mucus (4 and 38%), cramp (5 and 14%), leakage (2 and 27%), and blood (2 and 36%). Ninety percent of the patients' problems were minor.

    CONCLUSION: Pelvic irradiation induced a relatively large number of minor problems, evaluated with a self-assessment questionnaire and compared with an age-matched population of men, of approximately similar magnitude as with a physician's systematic evaluation. The most important urinary factors were urgency and leakage. The most important intestinal factors were blood, mucus, and leakage. The results support the ongoing efforts to use 3-D computed tomography-based conformal therapy to decrease irradiation dose to the rectum and bladder.

  • 41.
    Widmark, Anders
    et al.
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Gunnlaugsson, A.
    Beckman, L.
    Thellenberg-Karlsson, Camilla
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Hoyer, M.
    Lagerlund, M.
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Nursing.
    Kindblom, J.
    Ginman, C.
    Johansson, B.
    Seke, M.
    Björnlinger, K.
    Kjellén, E.
    Franzen, Lars
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Nilsson, P.
    Extreme Hypofractionation versus Conventionally Fractionated Radiotherapy for Intermediate Risk Prostate Cancer: Early Toxicity Results from the Scandinavian Randomized Phase III Trial "HYPO-RT-PC"2016In: International Journal of Radiation Oncology, Biology, Physics, ISSN 0360-3016, E-ISSN 1879-355X, Vol. 96, no 5, p. 938-939Article in journal (Refereed)
  • 42.
    Widmark, Anders
    et al.
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Gunnlaugsson, Adalsteinn
    Beckman, Lars
    Thellenberg-Karlsson, Camilla
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Hoyer, Morten
    Lagerlund, Magnus
    Kindblom, Jon
    Ginman, Claes
    Johansson, Bengt
    Björnlinger, Kirsten
    Seke, Mihajl
    Agrup, Måns
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Nursing.
    Tavelin, Björn
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Norman, David
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Zackrisson, Björn
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Anderson, Harald
    Kjellén, Elisabeth
    Franzén, Lars
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Nilsson, Per
    Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial2019In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 394, no 10196, p. 385-395Article in journal (Refereed)
    Abstract [en]

    Background: Hypofractionated radiotherapy for prostate cancer has gained increased attention due to its proposed high radiation-fraction sensitivity. Recent reports from studies comparing moderately hypofractionated and conventionally fractionated radiotherapy support the clinical use of moderate hypofractionation. To date, there are no published randomised studies on ultra-hypofractionated radiotherapy. Here, we report the outcomes of the Scandinavian HYPO-RT-PC phase 3 trial with the aim to show non-inferiority of ultra-hypofractionation compared with conventional fractionation.

    Methods: In this open-label, randomised, phase 3 non-inferiority trial done in 12 centres in Sweden and Denmark, we recruited men up to 75 years of age with intermediate-to-high-risk prostate cancer and a WHO performance status between 0 and 2. Patients were randomly assigned to ultra-hypofractionation (42·7 Gy in seven fractions, 3 days per week for 2·5 weeks) or conventional fractionated radiotherapy (78·0 Gy in 39 fractions, 5 days per week for 8 weeks). No androgen deprivation therapy was allowed. The primary endpoint was time to biochemical or clinical failure, analysed in the per-protocol population. The prespecified non-inferiority margin was 4% at 5 years, corresponding to a critical hazard ratio (HR) limit of 1·338. Physician-recorded toxicity was measured according to the Radiation Therapy Oncology Group (RTOG) morbidity scale and patient-reported outcome measurements with the Prostate Cancer Symptom Scale (PCSS) questionnaire. This trial is registered with the ISRCTN registry, number ISRCTN45905321.

    Findings: Between July 1, 2005, and Nov 4, 2015, 1200 patients were randomly assigned to conventional fractionation (n=602) or ultra-hypofractionation (n=598), of whom 1180 (591 conventional fractionation and 589 ultra-hypofractionation) constituted the per-protocol population. 1054 (89%) participants were intermediate risk and 126 (11%) were high risk. Median follow-up time was 5·0 years (IQR 3·1–7·0). The estimated failure-free survival at 5 years was 84% (95% CI 80–87) in both treatment groups, with an adjusted HR of 1·002 (95% CI 0·758–1·325; log-rank p=0·99). There was weak evidence of an increased frequency of acute physician-reported RTOG grade 2 or worse urinary toxicity in the ultra-hypofractionation group at end of radiotherapy (158 [28%] of 569 patients vs 132 [23%] of 578 patients; p=0·057). There were no significant differences in grade 2 or worse urinary or bowel late toxicity between the two treatment groups at any point after radiotherapy, except for an increase in urinary toxicity in the ultra-hypofractionation group compared to the conventional fractionation group at 1-year follow-up (32 [6%] of 528 patients vs 13 [2%] of 529 patients; (p=0·0037). We observed no differences between groups in frequencies at 5 years of RTOG grade 2 or worse urinary toxicity (11 [5%] of 243 patients for the ultra-hypofractionation group vs 12 [5%] of 249 for the conventional fractionation group; p=1·00) and bowel toxicity (three [1%] of 244 patients vs nine [4%] of 249 patients; p=0·14). Patient-reported outcomes revealed significantly higher levels of acute urinary and bowel symptoms in the ultra-hypofractionation group compared with the conventional fractionation group but no significant increases in late symptoms were found, except for increased urinary symptoms at 1-year follow-up, consistent with the physician-evaluated toxicity.

    Interpretation: Ultra-hypofractionated radiotherapy is non-inferior to conventionally fractionated radiotherapy for intermediate-to-high risk prostate cancer regarding failure-free survival. Early side-effects are more pronounced with ultra-hypofractionation compared with conventional fractionation whereas late toxicity is similar in both treatment groups. The results support the use of ultra-hypofractionation for radiotherapy of prostate cancer.

    Funding: The Nordic Cancer Union, the Swedish Cancer Society, and the Swedish Research Council.

  • 43.
    Widmark, Anders
    et al.
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Klepp, Olbjørn
    Solberg, Arne
    Damber, Jan-Erik
    Angelsen, Anders
    Fransson, Per
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Lund, Jo-Asmund
    Tasdemir, Ilker
    Hoyer, Morten
    Wiklund, Fredrik
    Fosså, Sophie D
    Endocrine treatment, with or without radiotherapy, in locally advanced prostate cancer (SPCG-7/SFUO-3): an open randomised phase III trial2009In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 373, no 9660, p. 301-308Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Several studies have shown the efficacy of endocrine therapy in combination with radiotherapy in high-risk prostate cancer. To assess the effect of radiotherapy, we did an open phase III study comparing endocrine therapy with and without local radiotherapy, followed by castration on progression.

    METHODS: This randomised trial included men from 47 centres in Norway, Sweden, and Denmark. Between February, 1996, and December, 2002, 875 patients with locally advanced prostate cancer (T3; 78%; PSA<70; N0; M0) were centrally randomly assigned by computer to endocrine treatment alone (3 months of total androgen blockade followed by continuous endocrine treatment using flutamide; 439 patients), or to the same endocrine treatment combined with radiotherapy (436 patients). The primary endpoint was prostate-cancer-specific survival, and analysis was by intention to treat. This study is registered as an international standard randomised controlled trial, number ISRCTN01534787.

    FINDINGS: After a median follow-up of 7.6 years, 79 men in the endocrine alone group and 37 men in the endocrine plus radiotherapy group had died of prostate cancer. The cumulative incidence at 10 years for prostate-cancer-specific mortality was 23.9% in the endocrine alone group and 11.9% in the endocrine plus radiotherapy group (difference 12.0%, 95% CI 4.9-19.1%), for a relative risk of 0.44 (0.30-0.66). At 10 years, the cumulative incidence for overall mortality was 39.4% in the endocrine alone group and 29.6% in the endocrine plus radiotherapy group (difference 9.8%, 0.8-18.8%), for a relative risk of 0.68 (0.52-0.89). Cumulative incidence at 10 years for PSA recurrence was substantially higher in men in the endocrine-alone group (74.7%vs 25.9%, p<0.0001; HR 0.16; 0.12-0.20). After 5 years, urinary, rectal, and sexual problems were slightly more frequent in the endocrine plus radiotherapy group.

    INTERPRETATION: In patients with locally advanced or high-risk local prostate cancer, addition of local radiotherapy to endocrine treatment halved the 10-year prostate-cancer-specific mortality, and substantially decreased overall mortality with fully acceptable risk of side-effects compared with endocrine treatment alone. In the light of these data, endocrine treatment plus radiotherapy should be the new standard.

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