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临床试验/NCT07529418
NCT07529418尚未招募不适用

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

Institute of Cancer Research, United Kingdom0 个研究点目标入组 800 人开始时间: 2026年5月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
800
主要终点
The impact of prostate cancer on quality of life

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Black men and those of Mixed ethnicity.

Black men of African, and Caribbean ancestry as well as men of Mixed ethnicity.

干预措施: Patient Reported Outcome Measurements (PROMs) (Other)

结局指标

主要结局

The impact of prostate cancer on quality of life

时间窗: 18 months

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

时间窗: 18 months

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

时间窗: 18 months

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

时间窗: 18 months

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

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

时间窗: 18 months

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

次要结局

  • Usability and acceptance of ePROMs(18 months)
  • Barriers and facilitators to successful ePROMs implementation(18 months)

研究者

发起方
Institute of Cancer Research, United Kingdom
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth Bancroft

Dr

Institute of Cancer Research, United Kingdom

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