Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07529418

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patient Reported Outcome Measurements (PROMs)

Other

Patient Reported Outcome Measurements collected via questionnaire

Primary outcomes

  1. The impact of prostate cancer on quality of life

    Time frame: 18 months

    Impact of prostate cancer on quality of life (measured through EORTC-QLQ-C30): overall health score, overall QoL score.

  2. The physical impact of treatments on quality of life

    Time frame: 18 months

    Physical impact of treatments on quality of life (measured through EPIC-26): sexual function, urinary function; bowel function; hormonal related symptoms.

  3. The impact of treatments in mental health outcomes

    Time frame: 18 months

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

  4. The functional impact of treatments on quality of life

    Time frame: 18 months

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

  5. Variation in health and wellbeing outcomes by treatment type and sociodemographic characteristics.

    Time frame: 18 months

    Variation in physical, mental health and functional outcomes by treatment type and sociodemographic characteristics.

Secondary outcomes

  1. Usability and acceptance of ePROMs

    Time frame: 18 months

    Usability and acceptance of ePROMs by patients and healthcare providers.

  2. Barriers and facilitators to successful ePROMs implementation

    Time frame: 18 months

    Identification of barriers and facilitators to successful ePROMs implementation.

Study contacts

Contact information is provided by the study sponsor or research team.

Denzil James, MSc

CONTACT

[email protected]

+44 (0)20 87224483

Esther Robijn

CONTACT

[email protected]

+31 (0)26 389 0680

Sponsors and collaborators

Lead sponsor

Institute of Cancer Research, United Kingdom

Other

Collaborators

  • European Association of Urology
  • Royal Marsden NHS Foundation Trust

Registry information

Official study title

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

Acronym: BALANCE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.