The BALANCE Study: BlAck and Mixed Men's Lived Experience With Prostate cANCEr-Diversity in Prostate Cancer PROMS Study (BALANCE)

BlAck and Mixed Men's Lived Experience With Prostate cANCEr - Diversity in Prostate Cancer PROMS Study

The BALANCE study is a prospective Patient Reported Outcomes Measures (PROMs) study developed to look at the quality of life (QoL) of patients diagnosed with prostate cancer (PCa) in communities underrepresented in research, especially Black men of African, and Caribbean ancestry as well as men of Mixed ethnicity. This study will also investigate various PCa treatment types and their mental health impact on patients. There is a lack of research on PROMs in diverse populations. Collecting PROMs specifically from Black men and individuals with prostates who are receiving/have received treatment for PCa is essential for understanding their unique post-treatment experiences. The insights are vital to addressing documented disparities, tailoring supportive care and ultimately providing equitable health outcomes.

Participants in this study will be asked to complete a questionnaire (either electronically or hardcopy) to share their insights following their PCa diagnosis.

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: Patient Reported Outcome Measurements (PROMs)

Detailed Description

The BALANCE study is a Patient Reported Outcomes Measures (PROMs) study developed to look at the quality of life (QoL) of patients diagnosed with prostate cancer (PCa) in communities underrepresented in research, especially Black men of African, and Caribbean ancestry as well as men of Mixed ethnicity. This study is a questionnaire based study collecting data through electronic surveys. The study will also investigate various PCa treatment types and their mental health impact on patients. There is a lack of research on PROMs in diverse populations. Collecting PROMs specifically from Black men and individuals with prostates who are receiving/have received treatment for PCa is essential for understanding their unique post-treatment experiences. The insights are vital to addressing documented disparities, tailoring supportive care and ultimately providing equitable health outcomes.

The study will recruit a minimum of 800 participants who will be asked to complete an electronic survey. Participants will be aged 18 years or over and have had a prostate cancer diagnosis. All participants will be asked to provide informed consent before proceeding with the survey. After consenting, participants will be able to access the electronic survey. Participants will have the opportunity to save their results and access the survey across multiple sessions if not able to complete in one sitting. However, they will be asked to complete the survey only once.

Potential participants will be identified through collaboration with cancer charities, support groups, hospitals, study advertisements in the press, use of social media (in collaboration with the European Association of Urology Patient Office, the funders of the study), outreach work in communities, presentations, cancer alliances, posters/leaflets and animation videos about the study that could be displayed in hospitals, public spaces and other community organisations. Participants will be able to either contact the study team, their associated cancer charity or support group to express interest in taking part in this study and receive further information.

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Esther Robijn; Phone Number: +31 (0)26 389 0680; Email: e.robijn@uroweb.org
• Study Contact Backup: Name: Denzil James, MSc; Phone Number: +44 (0)20 87224483; Email: denzil.james@rmh.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will recruit a minimum of 800 participants who are of either Black African, Caribbean or Mixed ancestry who will be asked to complete an electronic survey. Participants will be aged 18 years or over and have had a prostate cancer diagnosis.

Description

Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

• Age ≥ 18 years;

• Be of either:

  • Black African ancestry; OR
  • Black African-Caribbean ancestry; OR
  • Mixed Black ancestry.
• Diagnosed with PCa;
• Assigned male at birth;
• Participants with access to digital devices (smartphones, tablets, computers) or able to complete hardcopy versions of the survey;
• Participants willing to participate and provide informed consent.

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

• Participants having no diagnosis of PCa;
• Participants unable to provide consent;
• Participants assigned female at birth.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Black men and those of Mixed ethnicity.; Black men of African, and Caribbean ancestry as well as men of Mixed ethnicity.	Other: Patient Reported Outcome Measurements (PROMs); Patient Reported Outcome Measurements collected via questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The impact of prostate cancer on quality of life	Impact of prostate cancer on quality of life (measured through EORTC-QLQ-C30): overall health score, overall QoL score.	18 months
The physical impact of treatments on quality of life	Physical impact of treatments on quality of life (measured through EPIC-26): sexual function, urinary function; bowel function; hormonal related symptoms.	18 months
The impact of treatments in mental health outcomes	Impact of treatments in mental health outcomes (measured through EORTC-QLQ-C30): anxiety, depression, financial worries.	18 months
The functional impact of treatments on quality of life	Functional impact of treatments on QoL (measured through EORTC-QLQ-C30): energy levels, physical activity.	18 months
Variation in health and wellbeing outcomes by treatment type and sociodemographic characteristics.	Variation in physical, mental health and functional outcomes by treatment type and sociodemographic characteristics.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability and acceptance of ePROMs	Usability and acceptance of ePROMs by patients and healthcare providers.	18 months
Barriers and facilitators to successful ePROMs implementation	Identification of barriers and facilitators to successful ePROMs implementation.	18 months

Collaborators and Investigators

• Sponsor: Institute of Cancer Research, United Kingdom
• Collaborators: Royal Marsden NHS Foundation Trust; European Association of Urology
• Investigators: Study Director: Eamonn Rogers, FRCS(Urol), The European Association of Urology Patient Office

Publications and helpful links

Helpful Links

• BALANCE Study Webpage

Study record dates

Study Major Dates

• Study Start (Estimated): May 5, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: MEC-2025-0751

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymised data can be applied for via the Data Access Committee.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No