Early Diagnosis of PROstate CANcer for Black Men
ConditionProstate Cancer (Diagnosis)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age45+
SponsorUniversity of Sunderland
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Black men aged 45 years or over, living in North East England, North Yorkshire, London or Scotland
Disqualifiers
Men from other ethnicities
Black men aged less than 45 years
Black men with previous prostate cancer diagnosis
Trial design
Design model
Parallel
Treatments tested in this trial
The intervention is a two-hour workshop that includes multiple components to encourage Black men to request prostate cancer diagnosis tests.
Other interventionThe 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.
Waitlist
Other interventionParticipants in the control group will be placed on a waitlist to receive the intervention after six months
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlOther 1 intervention
Trial outcomes
Primary outcomes
1
Self-reported GP attendance to discuss prostate cancer health
Participants will be asked whether they discussed their risk of prostate cancer with their GPs and whether they requested a PSA test
Time frame
Baseline, 3 months, 6 months2
Self-reported PSA test
Participants will be asked if they had undergone a PSA test prior to the study and whether they underwent PSA testing following the intervention.
Time frame
Baseline, 3 months, 6 months3
GP recorded PSA tests
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.
Time frame
6 monthsSecondary outcomes
1
Knowledge of prostate cancer
Participants will be asked to complete questions adapted from Weinrich et al's (2004) knowledge of Prostate Cancer questionnaire
Time frame
Baseline, 3 months, 6 months2
Attitudes to prostate cancer
Thomas Jefferson University Prostate Cancer Screening survey will be used to assess attitudes towards prostate cancer screening
Time frame
Baseline, 3 months, 6 months3
Help-seeking behaviours
Help seeking behaviours related to prostate cancer will be assessed using items adapted from the Cancer Awareness Measure Plus (2024) questions.
Time frame
Baseline, 3 months, 6 monthsOther outcomes
1
Perspectives on the intervention's content and delivery
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.
Time frame
6 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Sunderland
Lead sponsor
University of Glasgow
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: