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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07529418
Acronym
BALANCE
Enrollment
800
Registered
2026-04-14
Start date
2026-05-05
Completion date
2027-03-01
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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.

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.

Interventions

OTHERPatient Reported Outcome Measurements (PROMs)

Patient Reported Outcome Measurements collected via questionnaire

Sponsors

Institute of Cancer Research, United Kingdom
Lead SponsorOTHER
Royal Marsden NHS Foundation Trust
CollaboratorOTHER
European Association of Urology
CollaboratorUNKNOWN

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The impact of prostate cancer on quality of life18 monthsImpact of prostate cancer on quality of life (measured through EORTC-QLQ-C30): overall health score, overall QoL score.
The physical impact of treatments on quality of life18 monthsPhysical impact of treatments on quality of life (measured through EPIC-26): sexual function, urinary function; bowel function; hormonal related symptoms.
The impact of treatments in mental health outcomes18 monthsImpact of treatments in mental health outcomes (measured through EORTC-QLQ-C30): anxiety, depression, financial worries.
The functional impact of treatments on quality of life18 monthsFunctional impact of treatments on QoL (measured through EORTC-QLQ-C30): energy levels, physical activity.
Variation in health and wellbeing outcomes by treatment type and sociodemographic characteristics.18 monthsVariation in physical, mental health and functional outcomes by treatment type and sociodemographic characteristics.

Secondary

MeasureTime frameDescription
Usability and acceptance of ePROMs18 monthsUsability and acceptance of ePROMs by patients and healthcare providers.
Barriers and facilitators to successful ePROMs implementation18 monthsIdentification of barriers and facilitators to successful ePROMs implementation.

Contacts

CONTACTEsther Robijn
e.robijn@uroweb.org+31 (0)26 389 0680
CONTACTDenzil James, MSc
denzil.james@rmh.nhs.uk+44 (0)20 87224483
STUDY_DIRECTOREamonn Rogers, FRCS(Urol)

The European Association of Urology Patient Office

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 15, 2026