CONTIGO - A Narrative Intervention to Enhance Genetic Counseling and Testing

Official title

Testing a Narrative Intervention to Enhance Genetic Counseling and Testing

Overview

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.

Detailed description

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.

Interventions

• Behavioral Culturally Targeted Narrative Video: "Is My Cancer Hereditary? Rosa Visits a Genetic Counselor."
  Participants randomized to the video arm will receive a link with a password by email or text message to watch the video, depending on participants' preference. Participants without internet access will receive a DVD. Participants will be instructed to watch the video alone with no interruptions. We will ask them not to share the link with others.
• Behavioral FORCE Fact Sheet
  Participants will receive a PDF of the fact sheet by email, text message, or a printed fact sheet by mail depending on participants' preferences. The fact sheet includes information about genes, breast cancer, risk factors for HBOC, genetic counseling and testing, and resources.

Primary outcome measures

• Uptake of Genetic Counseling [Time frame: Change from the baseline survey to four months after baseline]
• Uptake of Genetic Testing [Time frame: Change from the baseline survey to four months after baseline]

Secondary outcome measures (7)

• Knowledge about HBOC [Time frame: Change from the baseline to two-week after baseline, and change from two-week follow up survey to four months after baseline]
• Self-efficacy about attending genetic cancer risk assessment [Time frame: Change from the baseline to two-week after baseline]
• Beliefs and Attitudes about genetic cancer risk assessment [Time frame: Change from the baseline to two-week after baseline]
• Subjective norms about genetic cancer risk assessment [Time frame: Change from the baseline to two-week after baseline]
• Anticipatory emotions about genetic cancer risk assessment [Time frame: Change from the baseline to two-week after baseline]
• Acceptability of the intervention [Time frame: At two weeks after baseline]
• Feasibility of the intervention [Time frame: At two weeks after baseline]

Eligibility criteria

Inclusion criteria

Aim 1 and 2.

• 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

Aim 3.

• 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

Exclusion criteria

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 2 centers

• Georgetown Lombardi Comprehensive Cancer Center — Washington D.C.
• Virginia Commonwealth University — Richmond

Identifiers

NCT: NCT05130606 · STUDY00002789 · 1R01CA248543-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗