Testing a Narrative Intervention to Enhance Genetic Counseling and Testing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 332
- 试验地点
- 4
- 主要终点
- Uptake of Genetic Testing
研究概览
简要总结
This is a mixed-methods Hybrid Type 1 research design (efficacy study) in which we aim to conduct a two-arm randomized controlled trial and an Implementation Focused Process Evaluation of a culturally-targeted video and referral screening tool.
In this study, the investigators aim to evaluate the efficacy of a culturally targeted video previously developed by the research team vs. a Spanish-language fact sheet from an established group on enhancing genetic counseling and testing uptake and psychosocial outcomes in Latina women at risk for hereditary breast and ovarian cancer.
The investigators will test the video's efficacy while also gathering data on the implementation and future sustainability of using the Risk Screening Tool (RST) and video in community clinics.
详细描述
The investigators previously developed and piloted a culturally targeted narrative video in Spanish to provide HBOC and GCT education to at-risk Latinas. The investigators expanded traditional approaches to address psychosocial barriers through risk messages designed to elicit emotional responses; emotions are often stronger predictors of behavior than cognition. Our video is responsive to Latinas' preferences, targets motivators, and addresses psychosocial barriers identified in our formative research.
In this study, the investigators aim to evaluate the efficacy of our video vs. a fact sheet from an established group on enhancing GCT uptake and psychosocial outcomes on a two-arm randomized controlled trial. The investigators will test the video's efficacy while also gathering data on the implementation and future sustainability of using an adapted Risk Screening Tool (RST) and video in community clinics.
The investigators will partner with community clinics and implement a Risk Screening Tool (RST) at their practice to identify women at risk of HBOC. Community clinic staff (N~32) will be asked to participate in a pre-implementation and a post-implementation focus group to assess implementation outcomes of integrating HBOC screening practices in their clinic. Through the community clinics, the investigators aim to recruit N~300 Latina women at risk for HBOC based on their personal or family history of cancer. Latina women at risk for HBOC will be randomized to a Video arm or Fact Sheet Arm. All participants in the randomized controlled trial will be offered genetic counseling and testing.
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
- Female
- 接受健康志愿者
- 是
入选标准
- •Self-identify as a Latina woman
- •Be 18 years old or older
- •Be able to provide informed consent
- •Be fluent in Spanish
- •Meet NCCN criteria to be considered for genetic cancer risk assessment for HBOC, whether by a personal history of cancer or family history of cancer
- •No previous participation in genetic counseling or testing for hereditary breast and ovarian cancer risk
- •No other family members are participating in this study
- •Have not participated in any previous studies involving interventions about HBOC or GCT
- •Be 18 years old or older
- •Be fluent in English or Spanish
- •Have a role in the partner community clinic as either a) full-time or part-time employee b) intern c) volunteer
排除标准
- 未提供
结局指标
主要结局
Uptake of Genetic Testing
时间窗: Change from the baseline survey to four months after baseline
Participants will self report whether they completed a genetic test for hereditary cancer in the four months following their baseline survey. The study team will also have direct access to the genetic counseling company's records.
Uptake of Genetic Counseling
时间窗: Change from the baseline survey to four months after baseline
Participants will self report whether they attended a genetic counseling session in the four months following their baseline survey. The study team will also have direct access to the genetic counseling company's records.
次要结局
- Beliefs and Attitudes about genetic cancer risk assessment(Change from the baseline to two-week after baseline)
- Anticipatory emotions about genetic cancer risk assessment(Change from the baseline to two-week after baseline)
- Self-efficacy about attending genetic cancer risk assessment(Change from the baseline to two-week after baseline)
- Knowledge about HBOC(Change from the baseline to two-week after baseline, and change from two-week follow up survey to four months after baseline)
- Subjective norms about genetic cancer risk assessment(Change from the baseline to two-week after baseline)
- Feasibility of the intervention(At two weeks after baseline)
- Acceptability of the intervention(At two weeks after baseline)