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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Patient Reported Outcome Measurements (PROMs)
  Patient Reported Outcome Measurements collected via questionnaire

Первичные конечные точки

• The impact of prostate cancer on quality of life [Срок оценки: 18 months]
• The physical impact of treatments on quality of life [Срок оценки: 18 months]
• The impact of treatments in mental health outcomes [Срок оценки: 18 months]
• The functional impact of treatments on quality of life [Срок оценки: 18 months]
• Variation in health and wellbeing outcomes by treatment type and sociodemographic characteristics. [Срок оценки: 18 months]

Вторичные конечные точки (2)

• Usability and acceptance of ePROMs [Срок оценки: 18 months]
• Barriers and facilitators to successful ePROMs implementation [Срок оценки: 18 months]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07529418 · MEC-2025-0751

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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