About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years;
Black African ancestry; OR
Black African-Caribbean ancestry; OR
Mixed Black ancestry.
Disqualifiers
Participants having no diagnosis of PCa;
Participants unable to provide consent;
Participants assigned female at birth.
Trial 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.
Trial design
Other
Prospective
Treatments tested in this trial
Patient Reported Outcome Measurements (PROMs)
Other interventionPatient Reported Outcome Measurements collected via questionnaire
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
The impact of treatments in mental health outcomes
Impact of treatments in mental health outcomes (measured through EORTC-QLQ-C30): anxiety, depression, financial worries.
The functional impact of treatments on quality of life
Functional impact of treatments on QoL (measured through EORTC-QLQ-C30): energy levels, physical activity.
Secondary outcomes
Usability and acceptance of ePROMs
Usability and acceptance of ePROMs by patients and healthcare providers.
Barriers and facilitators to successful ePROMs implementation
Identification of barriers and facilitators to successful ePROMs implementation.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Institute of Cancer Research, United Kingdom
Lead sponsor
Royal Marsden NHS Foundation Trust
Collaborator
European Association of Urology
Collaborator
This trial is not recruiting at the moment. You can still explore other options: