CONTIGO - A Narrative Intervention to Enhance Genetic Counseling and Testing

August 22, 2025 updated by: Georgetown University

Testing a Narrative Intervention to Enhance Genetic Counseling and Testing

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

332

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Recruiting
        • Georgetown Lombardi Comprehensive Cancer Center
        • Contact:
    • Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Video Arm
Culturally Targeted Narrative Video: "Is My Cancer Hereditary? Rosa Visits a Genetic Counselor." Participants in the video arm will be asked to watch an 18-minute video that the research team developed and tested previously about HBOC and genetic services. The video is recorded with Spanish audio and is available with English subtitles.
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.
Active Comparator: Fact Sheet Arm
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uptake of Genetic Counseling
Time Frame: 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.
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
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.
Change from the baseline survey to four months after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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
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)
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
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).
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
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)
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
Scale items on a 7-point Likert-type response (from 1-strongly disagree to 7-strongly agree).
Change from the baseline to two-week after baseline
Acceptability of the intervention
Time Frame: 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
At two weeks after baseline
Feasibility of the intervention
Time Frame: At two weeks after baseline
Proportion of women who have watched/read the video or fact sheet at the two week follow up
At two weeks after baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of the Referral Screening Tool
Time Frame: Change from the pre-implementation focus groups with community clinics to post implementation focus groups with community clinics (48 months)
Qualitative measure captured through semi-structured interviews using the Consolidated Framework for Implementation Research. (e.g., What barriers and facilitators did you experience while implementing the RST?)
Change from the pre-implementation focus groups with community clinics to post implementation focus groups with community clinics (48 months)
Acceptability of the Referral Screening Tool
Time Frame: Change from the pre-implementation focus groups with community clinics to post implementation focus groups with community clinics (48 months)
Qualitative measure captured through semi-structured interviews using the Consolidated Framework for Implementation Research.
Change from the pre-implementation focus groups with community clinics to post implementation focus groups with community clinics (48 months)
Adoption of the Referral Screening Tool
Time Frame: At the post implementation focus groups with community clinics adoption over the previous 48 months will be assessed
Qualitative measure captured through semi-structured interviews using the Consolidated Framework for Implementation Research.
At the post implementation focus groups with community clinics adoption over the previous 48 months will be assessed
Sustainability of the Referral Screening Tool
Time Frame: At the post implementation focus groups with community clinics sustainability of the screener based on their experience during the previous 48 months will be assessed
Qualitative measure captured through semi-structured interviews using the Consolidated Framework for Implementation Research.
At the post implementation focus groups with community clinics sustainability of the screener based on their experience during the previous 48 months will be assessed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgetown University

Collaborators

National Cancer Institute (NCI)
Virginia Commonwealth University

Investigators

  • Principal Investigator: Alejandra Hurtado de Mendoza, Ph.D, Georgetown Lombardi Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

September 7, 2021

First Submitted That Met QC Criteria

November 10, 2021

First Posted (Actual)

November 23, 2021

Study Record Updates

Last Update Posted (Estimated)

August 28, 2025

Last Update Submitted That Met QC Criteria

August 22, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002789
  • 1R01CA248543-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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