Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient Reported Outcome Measurements (PROMs) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Black men and those of Mixed ethnicity.
- description
- Black men of African, and Caribbean ancestry as well as men of Mixed ethnicity.
- interventionNames
- Other: Patient Reported Outcome Measurements (PROMs)
Primary outcomes (5)
- measure
- The impact of prostate cancer on quality of life
- timeFrame
- 18 months
- description
- Impact of prostate cancer on quality of life (measured through EORTC-QLQ-C30): overall health score, overall QoL score.
- measure
- The physical impact of treatments on quality of life
- timeFrame
- 18 months
- description
- Physical impact of treatments on quality of life (measured through EPIC-26): sexual function, urinary function; bowel function; hormonal related symptoms.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available