CONTIGO - Informing Latinas About HBOC Risk

Not Applicable

• Conditions: Hereditary Breast and Ovarian Cancer
• Interventions: Behavioral: FORCE Fact Sheet

• Registration Number: NCT05130606
• Lead Sponsor: Georgetown University

Brief Summary

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.

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-11-10
• Study First Posted: 2021-11-23
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-09
• Last Update Posted: 2023-08-14
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 332

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fact Sheet Arm	FORCE Fact Sheet	Participants in the Fact Sheet arm will receive a Fact sheet about HBOC and genetic services and will be asked to read it in their own time. The Fact Sheet is available in English and Spanish.

Primary Outcome Measures

Name	Time	Method
Uptake of Genetic Testing	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	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.

Secondary Outcome Measures

Name	Time	Method
Beliefs and Attitudes about genetic cancer risk assessment	Change from the baseline to two-week after baseline	Changes in beliefs and attitudes about genetic counseling and genetic testing. The outcome will be assessed by 22 items from a scale developed by Sussner, Jandorf, Thompson et al., 2012 in which participants respond to a Likert-type scale from 1 (completely disagree) to 7 (completely agree).
Anticipatory emotions about genetic cancer risk assessment	Change from the baseline to two-week after baseline	Scale items on a 7-point Likert-type response (from 1-strongly disagree to 7-strongly agree).
Self-efficacy about attending genetic cancer risk assessment	Change from the baseline to two-week after baseline	Change in self-efficacy about genetic counseling and testing will be measured by specific items from the Theory of Planned Behavior scale (Ajzen, 2002) on a scale from 1-7 -Not at all to 7- Extremely)
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	9-item Scale from Kasting et al, 2019. The scale has statements to which participants respond True, False, or I don't Know. The scale is scored based on the accuracy of responses. A higher score indicates higher knowledge. Scores range from 0-9.
Subjective norms about genetic cancer risk assessment	Change from the baseline to two-week after baseline	Change in subjective norms about genetic counseling and testing will be measured by specific items from the Theory of Planned Behavior scale (Ajzen, 2002) on a scale from 1-Not at all to 7- Extremely)
Feasibility of the intervention	At two weeks after baseline	Proportion of women who have watched/read the video or fact sheet at the two week follow up
Acceptability of the intervention	At two weeks after baseline	Overall acceptability is measured on a 4-item self-reported scale ranging from 1 to 10, where 1 = not at all to 10 = highly

Trial Locations

Locations (2)

Georgetown Lombardi Comprehensive Cancer Center; 🇺🇸 Washington, District of Columbia, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States