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

NCT07529418 | Not Yet Recruiting DMC

• 1 other identifier: MEC-2025-0751
• Study Type: observational
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Usability and acceptance of ePROMs

  18 months

• Barriers and facilitators to successful ePROMs implementation

  18 months

Study Arms (1)

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)

Interventions

Patient Reported Outcome Measurements (PROMs) OTHER

Patient Reported Outcome Measurements collected via questionnaire

Black men and those of Mixed ethnicity.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: People born male or assigned male at birth.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead
• Royal Marsden NHS Foundation Trust: collaborator
• European Association of Urology: collaborator

Related Links

• BALANCE Study Webpage

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Eamonn Rogers, FRCS(Urol)

  The European Association of Urology Patient Office

  STUDY DIRECTOR

Central Study Contacts

Esther Robijn

CONTACT

+31 (0)26 389 0680; e.robijn@uroweb.org

Denzil James, MSc

CONTACT

+44 (0)20 87224483; denzil.james@rmh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 14, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share