- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07620717
Early Diagnosis of PROstate CANcer for Black Men (PROCAN-B+)
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
Stato
Condizioni
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
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Floor Christie-de Jong
- Numero di telefono: 0044 191 5153445
- Email: Floor.Christie-DeJong@sunderland.ac.uk
Backup dei contatti dello studio
- Nome: Rawand Jarrar
- Email: rawand.jarrar@sunderland.ac.uk
Criteri di partecipazione
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
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
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Floor Christie-de Jong, University of Sunderland
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie genitali
- Processi patologici
- Neoplasie genitali, maschio
- Neoplasie urogenitali
- Neoplasie per sede
- Neoplasie
- Malattie genitali, maschio
- Malattie della prostata
- Malattie urogenitali maschili
- Condizioni patologiche, segni e sintomi
- Neoplasie prostatiche
- Patologia
- Organizzazione e amministrazione
- Amministrazione dei servizi sanitari
- Appuntamenti e programmi
- Liste di attesa
Altri numeri di identificazione dello studio
- 101373
- G13007 (Altro numero di sovvenzione/finanziamento: Prostate Cancer Research (PCR))
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- ICF
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
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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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