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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorInstitute of Cancer Research, United Kingdom

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Patient Reported Outcome Measurements (PROMs)

    Other intervention

    Patient Reported Outcome Measurements collected via questionnaire

Treatment groups

800 Participants
are divided into 1 treatment group
Group A: Black men and those of Mixed ethnicity.1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
18 months
2

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.

Time frame
18 months
3

The impact of treatments in mental health outcomes

Impact of treatments in mental health outcomes (measured through EORTC-QLQ-C30): anxiety, depression, financial worries.

Time frame
18 months
4

The functional impact of treatments on quality of life

Functional impact of treatments on QoL (measured through EORTC-QLQ-C30): energy levels, physical activity.

Time frame
18 months

Secondary outcomes

1

Usability and acceptance of ePROMs

Usability and acceptance of ePROMs by patients and healthcare providers.

Time frame
18 months
2

Barriers and facilitators to successful ePROMs implementation

Identification of barriers and facilitators to successful ePROMs implementation.

Time frame
18 months

Other outcomes

Locations

This trial has no 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: