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

26 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

300

Fase

  • Non applicabile

Contatti e Sedi

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Contatto studio

Backup dei contatti dello studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Self-reported GP attendance to discuss prostate cancer health
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Knowledge of prostate cancer
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Perspectives on the intervention's content and delivery
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Collaboratori

Investigatori

  • Investigatore principale: Floor Christie-de Jong, University of Sunderland

Pubblicazioni e link utili

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Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

31 agosto 2028

Completamento dello studio (Stimato)

31 agosto 2028

Date di iscrizione allo studio

Primo inviato

26 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

26 maggio 2026

Primo Inserito (Effettivo)

2 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

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Descrizione del piano 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.

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione 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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • ICF
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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