A Randomized Controlled Trial to Enhance the Use of Genetic Counseling and Testing in Latinas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 8
- 主要终点
- Genetic counseling uptake
研究概览
简要总结
The investigators will conduct a two-arm RCT to evaluate the preliminary effectiveness of a culturally-adapted video developed by the team vs. a FORCE fact sheet on enhancing genetic cancer risk assessment (GCRA; including genetic counseling and option for genetic testing) uptake and psychosocial outcomes among Latinas at increased risk for hereditary breast and ovarian cancer (HBOC).
详细描述
The investigators will conduct a two-arm RCT to evaluate the preliminary effectiveness of a culturally-adapted video developed by the team vs. FORCE fact sheet on enhancing genetic cancer risk assessment (GCRA; including genetic counseling and option for genetic testing) uptake and psychosocial outcomes among Latinas at increased risk for hereditary breast and ovarian cancer (HBOC).
All participants will receive referrals to free telephone genetic counseling in Spanish to address cost, pragmatic, and language barriers. The investigators will recruit 28 Latina women at-risk of HBOC (14 randomized at each arm) at three sites with sizable Latinx populations. The sites include community clinics/health organizations and hospitals with whom we have established collaborations [Georgetown University (DC); Virginia Commonwealth University (VA)].
Results will improve efforts to translate genomic guidelines into practice and will reduce disparities by evaluating a low cost highly disseminable culturally-targeted video while gathering data on effectiveness and implementation.
Aim 1. Evaluate the impact of video vs. FORCE fact sheet on GCRA and testing uptake and psychosocial outcomes.
Aim 2. Assess implementation potential and needs by evaluating feasibility, acceptability, reach, and adoption of the intervention arms (video and FORCE fact sheet) and of the HBOC screening process at the community clinics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Older than 18 years-old
- •Self-identify as Latina
- •Fluent in Spanish
- •Meet NCCN criteria for breast and/or ovarian genetic cancer risk assessment based on -personal or family history of cancer
- •Have not received genetic counseling or genetic testing
- •Able to provide informed consent
- •No other members of the same family have participated
- •Must have access to the internet via smartphone, computer, or another device.
排除标准
- •Not fluent in Spanish
- •Previously received genetic counseling or genetic testing for HBOC
- •Previously participated in another interventional study about HBOC and GCRA
结局指标
主要结局
Genetic counseling uptake
时间窗: Baseline survey to three months after baseline
Proportion of participants that receive genetic counseling. The outcome will be assessed by self-report (e.g., Have you received genetic counseling in the past three months?) and confirmed with the genetic counseling company records.
次要结局
- Genetic testing uptake(Baseline survey to three months after baseline)