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Early Diagnosis of PROstate CANcer for Black Men (PROCAN-B+)

26. května 2026 aktualizováno: Floor Christie-de Jong, University of Sunderland

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

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.

Přehled studie

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

300

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

Inclusion Criteria:

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

Exclusion Criteria:

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Intervention
Participants in this arm will attend a two-hour community workshop designed to encourage informed help-seeking and engagement with prostate cancer health checks and PSA testing.
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.
Jiný: Control
Participants in this arm will be placed on a waiting list and will be invited to attend the workshop after the 6-month follow-up period.
Participants in the control group will be placed on a waitlist to receive the intervention after six months

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Self-reported GP attendance to discuss prostate cancer health
Časové okno: Baseline, 3 months, 6 months
Participants will be asked whether they discussed their risk of prostate cancer with their GPs and whether they requested a PSA test
Baseline, 3 months, 6 months
Self-reported PSA test
Časové okno: Baseline, 3 months, 6 months
Participants will be asked if they had undergone a PSA test prior to the study and whether they underwent PSA testing following the intervention.
Baseline, 3 months, 6 months
GP recorded PSA tests
Časové okno: 6 months
If participants consent, they will be asked to provide details of their GP practice to verify whether they underwent or requested PSA testing following the intervention. Letters will be sent to each GP practice to confirm whether participants had requested or undergone PSA testing.
6 months

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Knowledge of prostate cancer
Časové okno: Baseline, 3 months, 6 months
Participants will be asked to complete questions adapted from Weinrich et al's (2004) knowledge of Prostate Cancer questionnaire
Baseline, 3 months, 6 months
Attitudes to prostate cancer
Časové okno: Baseline, 3 months, 6 months
Thomas Jefferson University Prostate Cancer Screening survey will be used to assess attitudes towards prostate cancer screening
Baseline, 3 months, 6 months
Help-seeking behaviours
Časové okno: Baseline, 3 months, 6 months
Help seeking behaviours related to prostate cancer will be assessed using items adapted from the Cancer Awareness Measure Plus (2024) questions.
Baseline, 3 months, 6 months

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Perspectives on the intervention's content and delivery
Časové okno: 6 months
Participants, peer facilitators and professionals will be asked to take part in a qualitative process evaluation to explore their perspectives on the acceptability of the intervention content and delivery, and recommendations for future implementation.
6 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Spolupracovníci

Vyšetřovatelé

  • Vrchní vyšetřovatel: Floor Christie-de Jong, University of Sunderland

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. června 2026

Primární dokončení (Odhadovaný)

31. srpna 2028

Dokončení studie (Odhadovaný)

31. srpna 2028

Termíny zápisu do studia

První předloženo

26. května 2026

První předloženo, které splnilo kritéria kontroly kvality

26. května 2026

První zveřejněno (Aktuální)

2. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

2. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

26. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

Following study completion and publication of the main study findings, anonymised and de-identified data will be available from the principal investigator upon reasonable request and in accordance with ethical and data protection requirements.

Časový rámec sdílení IPD

We will aim to publish the study protocol in the first year of the study. Findings will be published following study completion.

Kritéria přístupu pro sdílení IPD

Following study completion and publication of the main study findings, anonymised and de-identified data will be available from the principal investigator upon reasonable request and in accordance with ethical and data protection requirements.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • ICF
  • CSR

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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