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

Abstract

BackgroundProstate 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 analysisPostal 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 disseminationThe 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.

The psychological impact of being on a monitoring pathway for localised prostate cancer: A UK‐wide mixed methods study

“…Full methodological details can be found in the protocol . Ethical and regulatory approvals were obtained (Newcastle and North Tyneside Research Ethics Committee [15/NE/0036], Health Research Authority Confidentiality Advisory Group [15/CAG/0110], and NHS Scotland Public Benefit and Privacy Panel [0516‐0364]).…”

“…Full methodological details can be found in the protocol. 21 23 and the six item version of the Kessler Psychological Distress Scale (K6) 24 (Data S1).…”

“…[15][16][17][18][19][20] Further exploration is needed to understand how men adjust to being on AS/WW. The Life After Prostate Cancer Diagnosis (LAPCD) study is a UKwide mixed methods study, 21 which aimed to explore the impact of PCa on men's well-being through a large-scale survey of men with PCa and interviews with a subsample. In this paper, we (a) compared the psychological outcomes in men with localised disease on AS/WW and men who received AT, using survey responses, and (b) explored the psychological adjustment of all interviewees on AS/WW, drawn from the total sample of interviewed men, to inform how future health services may best support this growing group of men.…”

Treatment for erectile dysfunction among older men in Northern Ireland

“…The data utilised were originally collected as part of the Life After Prostate Cancer Diagnosis (LAPCD) project for the purpose of acting as a general population baseline. In this survey, 10 000 men from NI, with no history of prostate cancer and aged over 40, were randomly selected from the NI General Practice Register by the Business Service Organisation (BSO).…”

“…Rigorous procedures, documented in detail by Downing et al were put in place to ensure respondent confidentiality. In brief, BSO dispatched questionnaires by post in September and October 2016, with a unique reference number (URN) on the form.…”