National guidelines recommend that women at increased risk for Hereditary Breast and Ovarian Cancer (HBOC) due to BRCA1/2 mutations be referred for genetic counseling and consider genetic testing. Awareness of a positive result can inform treatment decisions for cancer patients and risk management plans in both cancer survivors and women unaffected with cancer. The slow translation of guidelines into practice particularly impacts minority populations who receive services in community health clinics. Latina women have lower awareness and use of genetic counseling and testing (GCT) than non-Latina Whites. Latinas face multiple health care, pragmatic, and psychosocial barriers to GCT uptake. Latinas prefer culturally targeted interventions in Spanish with plain language, visual aids, and a narrative format. We developed a culturally targeted narrative video in Spanish for at-risk Latinas. Piloted in a single-arm trial (N=40), Latinas reported high satisfaction and exhibited a significant increase in knowledge from pre- to post-test. Nearly all participants (95%) reported an interest in GCT, and 62% completed genetic counseling. We will use an innovative hybrid research design that combines elements of traditional efficacy studies as well as best practices from implementation research to enhance the quality and speed of the translational process. Guided by an expanded Integrated Behavioral Model, we will conduct a RCT to evaluate the efficacy of our video vs. the FORCE fact sheet on enhancing GCT uptake and psychosocial outcomes. To maximize the potential for implementation in community clinics, we will train clinic staff to administer the Referral Screening Tool (RST), a validated tool to identify women at-risk of HBOC. Guided by the Consolidated Framework for Implementation Research, we will conduct an Implementation Focused Process Evaluation to gather data on clinic implementation outcomes for use of the Referral Screening Tool and the video. We will refer participants to free Spanish telephone genetic counseling. We will randomize 300 at-risk Latinas at four sites with large Latinx populations. Our primary outcome is genetic counseling uptake.
Aim 1. Evaluate the impact of our video vs. fact sheet on GCT uptake. Participants in the video arm will have higher genetic counseling uptake (H1.1.) and higher genetic testing uptake (H1.2.) at 4 months.
Aim 2. Evaluate the impact of our video vs. fact sheet on psychosocial and process evaluation outcomes. H2.1: Video participants will have higher knowledge, positive attitudes, subjective norms, self-efficacy, and positive anticipatory emotions. H2.2. Video participants will have higher acceptability and feasibility ratings. Exploratory aim: Evaluate mechanisms of the video's impact on genetic counseling uptake (knowledge, attitudes, norms, self-efficacy, anticipatory emotions). If counseling uptake does not differ by arm, then we will evaluate predictors of uptake.
Aim 3. Examine key implementation outcomes of feasibility, acceptability, adoption, fidelity, and future sustainability of using the Referral Screening Tool and the video at the community clinics.
Participating in genetic counseling and testing (GCT) can inform treatment and risk management decisions for women at-risk of hereditary breast and ovarian cancer, but Latina women underuse GCT services. This study will test the efficacy of a culturally targeted narrative video in enhancing GCT uptake and psychosocial outcomes in at-risk Latina women through a RCT. We will conduct an Implementation Focused Process Evaluation to gather implementation outcomes that will ultimately enhance the speed and quality of the translational process.
