Early Diagnosis of PROstate CANcer for Black Men

Официальное название

Encouraging Early Diagnosis of PROstate CANcer for Black Men (the PROCAN-B+ Study): A Mixed-Methods, Two-Arm, Multi-Centre Randomised Controlled Trial of a Co-Produced, Peer-Led Intervention

Обзор

PROCAN-B+ is a mixed-methods, two-arm, multi-centre randomised controlled trial evaluating a co-designed, peer-led intervention to encourage informed help-seeking and engagement with prostate cancer health checks and Prostate Specific Antigen (PSA) testing among Black men aged 45 years and over with no history of prostate cancer. The study will recruit 300 participants across three UK sites: North East England including Leeds, Scotland, and London. Following eligibility screening and baseline data collection, participants will be individually randomised in a 1:1 ratio to either the intervention or wait-list control arm by an independent clinical trials unit. Participants allocated to the intervention arm will attend a two-hour co-designed community-based workshop shortly after randomisation, while participants allocated to the control arm will be invited to attend the workshop following the 6-month follow-up period. Due to the nature of the intervention, participants and researchers will not be blinded to allocation. The intervention was co-designed in partnership with Black men and includes peer-led discussions on barriers to early diagnosis of prostate cancer, health education delivered by a Black GP, activities aimed at supporting effective communication with healthcare professionals, and video testimonials from prostate cancer survivors, women, and religious leaders. Primary outcomes include self-reported discussions with GPs relating to prostate cancer risk, self-reported PSA testing, and GP-recorded PSA testing where participant consent is provided. Secondary outcomes include knowledge of prostate cancer, attitudes towards prostate cancer health checks and PSA testing, and help-seeking behaviours. Data will be collected at baseline, 3-month, and 6-month follow-up. A qualitative process evaluation involving participants, peer facilitators, and professionals will explore experiences and acceptability of the intervention and inform future implementation and scale-up.

Подробное описание

Black men have approximately twice the risk of developing prostate cancer compared with non-Black men and are more likely to experience poorer prostate cancer outcomes. Despite this increased risk, barriers including lack of awareness of prostate cancer risk, discomfort discussing sensitive health issues, and negative experiences with healthcare may contribute to delays in healp-seeking and early diagnosis.

To address these barriers, we worked with thirteen Black men to co-design a peer-led, community-centred intervention aimed at encouraging help-seeking and engagement with prostate cancer health checks and PSA testing. The intervention consist of a two-hour workshop including peer-led discussions on barriers to early diagnosis of prostate cancer, health education delivered by a Black GP, activities to support effective communication with healthcare providers, and video messages from prostate cancer survivors, women and religious leaders. The workshop also included a social component with music and food.

The intervention was piloted with 62 Black men in 2023-2024. Participants completed surveys before and after the intervention assessing changes in knowledge, attitudes and intentions relating to prostate cancer health checks and PSA testing. Findings suggested improved knowledge, attitudes and intentions. However, the sample size was small and robust effectiveness evaluation with a larger sample is now needed.

The PROCAN-B+ study is a two-arm multi-centre randomised controlled trial (RCT) with an embedded qualitative process evaluation. We aim to recruit 300 Black men aged 45 and over from three sites (100 per site): North East England and North Yorkshire, London and Scotland. Following eligibility screening and baseline data collection, participants will be individually randomised in a 1:1 ratio to intervention or wait-list control groups by an independent clinical trials unit. Intervention participants will receive the intervention workshops shortly after being recruited; while participants allocated to the wait-list control arm will be invited to attend the workshop following the 6-month follow-up period. Due to the nature of the intervention, participants and researchers will not be blinded to allocation.

Intervention workshop delivery will be supported by community members (n=15) who will be trained on workshop facilitation to become peer facilitators.

To assess effectiveness, participants will be asked to complete baseline questionnaires assessing knowledge of prostate cancer, attitudes towards prostate cancer health checks and PSA testing, and self-reported PSA testing. Follow-up questionnaires will be completed post intervention and at 3-month and 6-month follow-up. If participants provide consent, details of their general practitioners (GP) practice will be collected to enable verification of GP-recorded PSA testing at 6-month follow-up. Questionnaires will be administered online, using Qualtrics, or in paper format.

The qualitative process evaluation will involve focus groups and interviews with participants, peer facilitators and professionals to explore experiences and acceptability of the intervention and recommendations for improvement for future implementation and scale-up.

Вмешательства

• Другое The intervention is a two-hour workshop that includes multiple components to encourage Black men to request prostate cancer diagnosis tests.
  The intervention was co-designed in partnership with 13 Black men to address barriers and facilitators to early diagnosis of prostate cancer among Black men. The workshop includes multiple components, including peer-led discussions on barriers to early diagnosis, health education delivered by a Black GP, activities aimed at supporting effective communication with GPs and reception staff, and video testimonials from prostate cancer survivors, women, and religious leaders.
• Другое Waitlist
  Participants in the control group will be placed on a waitlist to receive the intervention after six months

Первичные конечные точки

• Self-reported GP attendance to discuss prostate cancer health [Срок оценки: Baseline, 3 months, 6 months]
• Self-reported PSA test [Срок оценки: Baseline, 3 months, 6 months]
• GP recorded PSA tests [Срок оценки: 6 months]

Вторичные конечные точки (3)

• Knowledge of prostate cancer [Срок оценки: Baseline, 3 months, 6 months]
• Attitudes to prostate cancer [Срок оценки: Baseline, 3 months, 6 months]
• Help-seeking behaviours [Срок оценки: Baseline, 3 months, 6 months]

Критерии участия

Критерии включения

• Black men aged 45 years or over, living in North East England, North Yorkshire, London or Scotland

Критерии исключения

• Men from other ethnicities
• Black men aged less than 45 years
• Black men with previous prostate cancer diagnosis

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Christie-de Jong F, Eberhardt J, Oyeniyi OS, Ratcliffe E, Kabuye J, Kalemba M, Nnyanzi LA, Murphy MK, Robb KA. A mixed-methods evaluation of a peer-led, co-produced, asset-based intervention for early diagnosis of prostate cancer for Black men: the PROCAN-B study. BMJ Open. 2025 Nov 9;15(11):e105803. doi: 10.1136/bmjopen-2025-105803. PMID 41213686

Идентификаторы

NCT: NCT07620717 · 101373 · G13007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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