Social and Environmental Determinants of Breast Cancer Survivorship: the Black Breast Cancer Survivor's Intervention (BBCSI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Safety and Adverse Events (AEs)
研究概览
简要总结
The goal of this research study is to learn about the effects of the BBCSI course on the quality of life of Black breast cancer survivors.
A community-based and peer-led Black Breast Cancer Survivor's Intervention (BBCSI) course has been developed to help improve the quality of life of Black breast cancer survivors.
详细描述
Primary Objectives:
Develop a prototype of the BBCSI curriculum and assess satisfaction of the intervention.
Determine the preliminary efficacy of the BBCSI.
Evaluate fidelity, feasibility, acceptability, barriers, and facilitators of the BBCSI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Master Trainers:
- •To be eligible to participate in this study, an individual must meet all the following criteria:
- •Adult women aged 18 years and older
- •Histologically confirmed stage 0-III breast cancer
- •No evidence of metastatic disease
- •Self-identify as Black
- •Able to communicate in English
- •Participants:
- •To be eligible to participate in this study, an individual must meet all the following criteria:
- •Adult women aged 18 years and older
- •Histologically confirmed stage 0-III breast cancer
- •No evidence of metastatic disease
- •Self-identify as Black
- •Able to communicate in English
- •Community Interventionists:
- •To be eligible to participate in this study, an individual must meet all the following criteria:
- •Adult women aged 18 years and older
- •Histologically confirmed stage 0-III breast cancer
- •No evidence of metastatic disease
- •Self-identify as Black
- •Former study participants that have completed the intervention
- •Able to communicate in English
排除标准
- •Men or woman below 18 years of age
- •Does not have a histologically confirmed breast cancer
- •There's evidence of metastatic disease
- •Does not self-identify as Black
- •Unable to communicate in English
- •Additional Exclusion Criteria - Community Interventionists
- •1. Has not previously participated in and completed the study intervention as a participant
研究组 & 干预措施
Immediate Intervention Group
Participants will be recruited through our Community Based Organizations (CBOs) and other community collaborator networks.
干预措施: Black Breast Cancer Survivor's Intervention (Behavioral)
Wait-List (start in week 7)
Participants will be recruited through our Community Based Organizations (CBOs) and other community collaborator networks.
干预措施: Black Breast Cancer Survivor's Intervention (Behavioral)
结局指标
主要结局
Safety and Adverse Events (AEs)
时间窗: Time Frame: Through study completion; an average of 1 year
Safety and Adverse Events (AEs)
Safety and Adverse Events (AEs)
时间窗: Time Frame: Through study completion; an average of 1 year
Safety and Adverse Events (AEs)
次要结局
未报告次要终点