Decision regret in men living with and beyond nonmetastatic prostate cancer in the United Kingdom: A population-based patient-reported outcome study.

OBJECTIVE: Clinical options for managing nonmetastatic prostate cancer (PCa) vary. Each option has side effects associated with it, leading to difficulty in decision-making. This study aimed to assess the relationship between patient involvement in treatment decision-making and subsequent decision regret (DR), and quantify the impact of health-related quality of life (HRQL) outcomes on DR. METHODS: Men living in the United Kingdom, 18 to 42 months after diagnosis of PCa, were identified from cancer registration data and sent a questionnaire. Measures included the Decision Regret Scale (DRS), Expanded Prostate cancer Index Composite short form (EPIC-26), EQ-5D-5L, and an item on involvement in treatment decision-making. Multivariable ordinal regression was utilized, with DR categorized as none, mild, or moderate/severe regret. RESULTS: A total of 17 193 men with stage I-III PCa completed the DRS: 36.6% reported no regret, 43.3% mild regret, and 20.0% moderate/severe regret. The odds of reporting DR were greater if men indicated their views were not taken into account odds ratio ([OR] = 6.42, 95% CI: 5.39-7.64) or were involved "to some extent" in decision-making (OR = 4.63, 95% CI: 4.27-5.02), compared with men who were "definitely" involved. After adjustment, including for involvement, men reporting moderate/big problems with urinary, bowel, or sexual function were more likely to experience regret compared with men with no/small problems. Better HRQL scores were associated with lower levels of DR. CONCLUSIONS: This large-scale study demonstrates the benefit of patient involvement in treatment decision-making for nonmetastatic PCa. However, men experiencing side effects and poorer HRQL report greater DR. Promoting engagement in clinical decision-making represents good practice and may reduce the risk of subsequent regret.

Quality of life in men living with advanced and localised prostate cancer in the UK: a population-based study.

BACKGROUND: Little is known about the health-related quality of life (HRQOL) of men living with advanced prostate cancer. We report population-wide functional outcomes and HRQOL in men with all stages of prostate cancer and identify implications for health-care delivery. METHODS: For this population-based study, men in the UK living 18-42 months after diagnosis of prostate cancer were identified through cancer registration data. A postal survey was administered, which contained validated measures to assess functional outcomes (urinary incontinence, urinary irritation and obstruction, bowel, sexual, and vitality and hormonal function), measured with the Expanded Prostate Cancer Index Composite short form (EPIC-26), plus questions about use of interventions for sexual dysfunction) and generic HRQOL (assessed with the 5-level EuroQol five dimensions questionnaire [EQ-5D-5L] measuring mobility, self-care, usual activities, pain or discomfort, and anxiety or depression, plus a rating of self-assessed health). Log-linear and binary logistic regression models were used to compare functional outcomes and HRQOL across diagnostic stages and self-reported treatment groups. Each model included adjustment for age, socioeconomic deprivation, and number of other long-term conditions. FINDINGS: 35 823 (60·8%) of 58 930 men responded to the survey. Disease stage was known for 30 733 (85·8%) of 35 823 men; 19 599 (63·8%) had stage I or II, 7209 (23·4%) stage III, and 3925 (12·8%) stage IV disease. Mean adjusted EPIC-26 domain scores were high, indicating good function, except for sexual function, for which scores were much lower. Compared with men who did not receive androgen deprivation therapy, more men who received the therapy reported moderate to big problems with hot flushes (30·7% [95% CI 29·8-31·6] vs 5·4% [5·0-5·8]), low energy (29·4% [95% CI 28·6-30·3] vs 14·7% [14·2-15·3]), and weight gain (22·5%, 21·7-23·3) vs 6·9% [6·5-7·3]). Poor sexual function was common (81·0%; 95% CI 80·6-81·5), regardless of stage, and more than half of men (n=18 782 [55·8%]) were not offered any intervention to help with this condition. Overall, self-assessed health was similar in men with stage I-III disease, and although slightly reduced in those with stage IV cancer, 23·5% of men with metastatic disease reported no problems on any EQ-5D dimension. INTERPRETATION: Men diagnosed with advanced disease do not report substantially different HRQOL outcomes to those diagnosed with localised disease, although considerable problems with hormonal function and fatigue are reported in men treated with androgen deprivation therapy. Sexual dysfunction is common and most men are not offered helpful intervention or support. Service improvements around sexual rehabilitation and measures to reduce the effects of androgen deprivation therapy are required. FUNDING: The Movember Foundation, in partnership with Prostate Cancer UK.

Urinary, bowel and sexual health in older men from Northern Ireland.

OBJECTIVES: To provide data on the prevalence of urinary, bowel and sexual dysfunction in Northern Ireland (NI), to act as a baseline for studies of prostate cancer outcomes and to aid service provision within the general population. SUBJECTS AND METHODS: A cross-sectional postal survey of 10 000 men aged ≥40 years in NI was conducted and age-matched to the distribution of men living with prostate cancer. The EuroQoL five Dimensions five Levels (EQ-5D-5L) and 26-item Expanded Prostate Cancer Composite (EPIC-26) instruments were used to enable comparisons with prostate cancer outcome studies. Whilst representative of the prostate cancer survivor population, the age-distribution of the sample differs from the general population, thus data were generalised to the NI population by excluding those aged 40-59 years and applying survey weights. Results are presented as proportions reporting problems along with mean composite scores, with differences by respondent characteristics assessed using chi-squared tests, analysis of variance, and multivariable log-linear regression. RESULTS: Amongst men aged ≥60 years, 32.8% reported sexual dysfunction, 9.3% urinary dysfunction, and 6.5% bowel dysfunction. In all, 38.1% reported at least one problem and 2.1% all three. Worse outcome was associated with increasing number of long-term conditions, low physical activity, and higher body mass index (BMI). Urinary incontinence, urinary irritation/obstruction, and sexual dysfunction increased with age; whilst urinary incontinence, bowel, and sexual dysfunction were more common among the unemployed. CONCLUSION: These data provide an insight into sensitive issues seldom reported by elderly men, which result in poor general health, but could be addressed given adequate service provision. The relationship between these problems, raised BMI and low physical activity offers the prospect of additional health gain by addressing public health issues such as obesity. The results provide essential contemporary population data against which outcomes for those living with prostate cancer can be compared. They will facilitate greater understanding of the true impact of specific treatments such as surgical interventions, pelvic radiation or androgen-deprivation therapy.

Key factors associated with social distress after prostate cancer: Results from the United Kingdom Life after Prostate Cancer diagnosis study.

BACKGROUND: More men are living following a prostate cancer (PCa) diagnosis. They may need support to maximize the quality of their survival. Physical and psychological impacts of PCa are widely documented. Less is known about social impacts. We aimed to identify key factors associated with social distress following PCa. METHODS: The Life After Prostate Cancer Diagnosis study is a UK national cross-sectional survey of men 18-42 months post diagnosis of PCa. Men (n = 58 930) were invited to participate by their diagnosing cancer centre including 82% of English NHS Trusts (n = 111) and 100% of all Health Boards in Northern Ireland (n = 5), Scotland (n = 14) and Wales (n = 6). Social distress was measured using the Social Difficulties Inventory (SDI-21), 16 item Social Distress scale with men assigned to 'socially distressed'/'not socially distressed' groups, according to published guidelines. Clinical and sociodemographic variables were collected from self-report and cancer registries. RESULTS: Response rate 60.8% (n = 35 823) of whom 97% (n = 29 351) completed the Social Distress scale (mean age = 71.2; SD = 7.88). The proportion of 'socially distressed' men was 9.4%. Multivariable logistic regression analysis revealed unemployment versus employment (odds ratio (OR): 11.58 [95% CI 9.16-14.63]) and ≥3 co-morbidities versus none (OR: 5.37 [95% CI 4.61-6.27]) as key associations. Others were Androgen Deprivation Therapy, External Beam Radiotherapy in combination with another treatment, age, prior mental health problems and living in a socio-economically deprived area. CONCLUSION: Most men following PCa are socially resilient. A simple checklist could help clinicians identify men at risk of social distress.

Regional Variations in Quality of Survival Among Men with Prostate Cancer Across the United Kingdom.

BACKGROUND: Prostate cancer incidence, treatment, and survival rates vary throughout the UK, but little is known about regional differences in quality of survival. OBJECTIVE: To investigate variations in patient-reported outcomes between UK countries and English Cancer Alliances. DESIGN, SETTING, AND PARTICIPANTS: A cross-sectional postal survey of prostate cancer survivors diagnosed 18-42mo previously. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Urinary, bowel, and sexual problems and vitality were patient reported using the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire. General health was also self-assessed. Regional variations were identified using multivariable log-linear regression. RESULTS AND LIMITATIONS: A total of 35823 men responded, 60.8% of those invited. Self-assessed health was significantly lower than the UK average in Wales and Scotland. Respondents reported more urinary incontinence in Scotland, more urinary irritation/obstruction in Scotland and Northern Ireland (NI), poorer bowel function in Scotland and NI, worse sexual function in Scotland, and reduced vitality/hormonal function in Scotland, Wales, and NI. Self-assessed health was poorer than the English average in South Yorkshire and North-East and Cumbria, with more urinary incontinence in North-East and Cumbria and Peninsula, greater sexual problems in West Midlands, and poorer vitality in North-East and Cumbria and West Midlands. Limitations include difficulty identifying clinically significant differences and limited information on pretreatment conditions. CONCLUSIONS: Despite adjustment for treatment, and clinical and sociodemographic factors, quality of survival among prostate cancer survivors varied by area of residence. Adoption of best practice from areas performing well could support enhanced survival quality in poorer performing areas, particularly with regard to bowel problems and vitality, where clinically relevant differences were reported. PATIENT SUMMARY: We conducted a UK-wide survey of patient's quality of life after treatment for prostate cancer. Outcomes were found to vary depending upon where patients live. Different service providers need to ensure that all prostate cancer patients receive the same follow-up care.

Life after prostate cancer diagnosis: protocol for a UK-wide patient-reported outcomes study.

BACKGROUND: Prostate cancer and its treatment may impact physically, psychologically and socially; affecting the health-related quality of life of men and their partners/spouses. The Life After Prostate Cancer Diagnosis (LAPCD) study is a UK-wide patient-reported outcomes study which will generate information to improve the health and well-being of men with prostate cancer. METHODS AND ANALYSIS: Postal surveys will be sent to prostate cancer survivors (18-42 months postdiagnosis) in all 4 UK countries (n=∼70 000). Eligible men will be identified and/or verified through cancer registration systems. Men will be surveyed twice, 12 months apart, to explore changes in outcomes over time. Second, separate cohorts will be surveyed once and the design will include evaluation of the acceptability of online survey tools. A comprehensive patient-reported outcome measure has been developed using generic and specific instruments with proven psychometric properties and relevance in national and international studies. The outcome data will be linked with administrative health data (eg, treatment information from hospital data). To ensure detailed understanding of issues of importance, qualitative interviews will be undertaken with a sample of men who complete the survey across the UK (n=∼150) along with a small number of partners/spouses (n=∼30). ETHICS AND DISSEMINATION: The study has received the following approvals: Newcastle and North Tyneside 1 Research Ethics Committee (15/NE/0036), Health Research Authority Confidentiality Advisory Group (15/CAG/0110), NHS Scotland Public Benefit and Privacy Panel (0516-0364), Office of Research Ethics Northern Ireland (16/NI/0073) and NHS R&D approval from Wales, Scotland and Northern Ireland. Using traditional and innovative methods, the results will be made available to men and their partners/spouses, the funders, the NHS, social care, voluntary sector organisations and other researchers.