Improving Engagement From Underserved Communities With Prostate Cancer Genetics Services (INCLUDE PC)

February 5, 2026 updated by: Royal Marsden NHS Foundation Trust

Improving the Engagement of Underserved Communities With the Prostate Cancer Genetics Service: Identifying Barriers & Facilitators and Developing Supportive Resources Using a Co-production and Collaborative Approach

Earlier work explored barriers and facilitators to accessing prostate cancer screening, particularly in underserved communities, and provided valuable insights to build upon.

This study will explore perspectives on how genetic risk for prostate cancer is explained and understood through in-depth interviews with members of underserved communities. Findings from this work, alongside earlier results, will be used to co-design clear and accessible digital educational resources in collaboration with community members and relevant charities.

Participation in cancer screening programmes in the UK varies, with differences linked to socioeconomic status, ethnicity and health literacy. Similar inequalities are seen in access to prostate cancer genetics services, indicating a need for improved engagement.

Successful integration of genetics into prostate cancer care requires clear and inclusive information about genetic testing processes, possible outcomes and interpretation of results. Currently, there are limited resources explaining genetic risk for prostate cancer in an accessible way.

Co-production with representatives from underserved communities will ensure that educational materials are understandable, relevant and acceptable to all.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There is variability in uptake of cancer screening programmes in the UK with participation affected by socioeconomic status, ethnicity & health literacy. This lack of representation is also seen within the prostate cancer genetics service, suggesting that further work is required to promote engagement. The successful mainstream integration of genetics into prostate cancer management will require people to understand the process, potential outcomes and interpretation of results. In addition, the information provided should be inclusive.

The barriers and facilitators to accessing prostate cancer screening work commenced under a service evaluation (CCR SE1284). This project provided valuable data from underserved communities which we wish to build on. This study aims to further explore perspectives on genetic risk explanation and education in further depth using semi-structured interviews and to use these and earlier findings to co-design educational digital materials to raise awareness about prostate cancer and genetic risk measurement, in keeping with the wishes from the communities that have worked with us.

Development of educational multi-media materials:

Utilising the Medical Research Council's Complex Intervention Design Framework, we will co-design educational materials, using the data collected from community champions and relevant charities.

Evaluation of educational multi-media materials:

The co-designed education materials will undergo evaluation in a pilot phase and then again after dissemination. Methods of evaluation will be adopted to include acceptability, usability and integration into clinical practice.

There are few current resources explaining the genetic risk of prostate cancer and opportunities to participate in genetic risk studies. The study will work alongside representatives from underserved communities to ensure that educational materials developed are accessible and acceptable to all.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Men and people with prostates from the following three communities:

  • Black African and Black Caribbean
  • Transgender women and non-binary people with prostates
  • Reduced access to healthcare

Description

Inclusion Criteria:

  1. Men and people with prostates age 18 and above
  2. Those who belong to the three underserved groups; Black African and Black Caribbean Ancestry, transgender and non-binary people with a prostate and those with reduced access to healthcare
  3. We allow intersectionality within reason and will narratively describe any instances of these in the writeup of findings
  4. Those who are able to freely consent to inclusion
  5. Individuals with and without a lived experience of prostate cancer

Exclusion Criteria:

  1. To avoid exhaustion, we will only allow participation in two interview or focus groups per individual for the entirety of the study
  2. Those without capacity to consent to interview (capacity is assumed unless there is good reason to believe otherwise)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Semi-structured interview participants
Up to 60 participants for semi-structured interviews, 20 from each of the following underserved groups in prostate cancer screening; Black African and Black Caribbean, transgender and non-binary with a prostate, reduced access to healthcare.
Other: Surveys
Up to 30 surveys with 10 of these individuals undergoing short interviews to assess the improvement of their understanding around prostate cancer
Other: Semi-structured interviews and focus groups
Up to 60 total semi-structured interviews (up to 20 per underserved group) to assess barriers and facilitators to prostate cancer screening and how they would like information to improve their understanding to be presented.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluation of educational materials, demonstrating that users have an increase in understanding or prostate cancer risk and symptoms as well as genetic risk.
Time Frame: February 2026 to August 2026
Using surveys (before and after use of resources) and interviews to measure improvement in understanding in individuals without experience of prostate cancer.
February 2026 to August 2026
Increased representation from underserved groups in the referrals to our genetic research studies.
Time Frame: As soon as the educational materials are live, which we aim to be from June 2026, increase in referrals to our genetic research studies from under-represented groups will be measured. This will take place for 12 months.
Using demographic data from referrals via our website to our genetic research studies
As soon as the educational materials are live, which we aim to be from June 2026, increase in referrals to our genetic research studies from under-represented groups will be measured. This will take place for 12 months.
Qualitative data such as hits to the webpage and scroll depth and how many have signed up to the genetic research studies via the website.
Time Frame: These data will be collected from as soon as the webpage goes live for the subsequent 12 months.
This is a short term measure of how effective and engaging the resources are.
These data will be collected from as soon as the webpage goes live for the subsequent 12 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Improved representation of underrepresented groups in our genetic risk studies.
Time Frame: Measurements of the demographics of our research participants takes place currently. Any signficant change in representation will be reported for a minimum 12 months after the webpage and resources go live.
Recruits to our genetic research studies will be screened for demographics.
Measurements of the demographics of our research participants takes place currently. Any signficant change in representation will be reported for a minimum 12 months after the webpage and resources go live.
Reduced barriers to prostate cancer screening and participation in genetic research faced by underrepresented communities
Time Frame: The web page will go live in July 2026 and will be a long term resource (many years), regularly updated by our team. There will also be rounds of evaluation, using surveys and interviews, with subsequent adaption.
These resources will be distributed by the community champions who we have co-designed them with. These community champions have social media networks with a strong following in their respective community and they are trusted by community members. Therefore, the resources and the webpage will have a far reach within the community to encourage engagement with empowering information and to promote prostate cancer screening and participation with our genetic risk studies.
The web page will go live in July 2026 and will be a long term resource (many years), regularly updated by our team. There will also be rounds of evaluation, using surveys and interviews, with subsequent adaption.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Royal Marsden NHS Foundation Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ros Eeles, Institute of Cancer Research, United Kingdom

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 361063

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There will be no confidential data shared outside of the research team and the study participants are members of the public, not patients.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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