- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Floor Christie-de Jong
- Telefonnummer: 0044 191 5153445
- E-mail: Floor.Christie-DeJong@sunderland.ac.uk
Undersøgelse Kontakt Backup
- Navn: Rawand Jarrar
- E-mail: rawand.jarrar@sunderland.ac.uk
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Andet: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Self-reported GP attendance to discuss prostate cancer health
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Knowledge of prostate cancer
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Perspectives on the intervention's content and delivery
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Floor Christie-de Jong, University of Sunderland
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Genitale sygdomme
- Patologiske processer
- Genitale neoplasmer, mandlige
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer
- Kønssygdomme, mandlige
- Prostatasygdomme
- Mandlige urogenitale sygdomme
- Patologiske tilstande, tegn og symptomer
- Prostatiske neoplasmer
- Sygdom
- Organisation og administration
- Sundhedstjenester Administration
- Aftaler og tidsplaner
- Ventelister
Andre undersøgelses-id-numre
- 101373
- G13007 (Andet bevillings-/finansieringsnummer: Prostate Cancer Research (PCR))
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- ICF
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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