CONTIGO - A Narrative Intervention to Enhance Genetic Counseling and Testing

ConditionHereditary Breast and Ovarian Cancer

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorGeorgetown University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Self-identify as a Latina woman

Be 18 years old or older

Be able to provide informed consent

Be fluent in Spanish

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Culturally Targeted Narrative Video: "Is My Cancer Hereditary? Rosa Visits a Genetic Counselor."
Behavioral
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.
FORCE Fact Sheet
Behavioral
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.

Treatment groups

332 Participants

are divided into 2 treatment groups

Group A: Video ArmExperimental treatment 1 intervention

Group B: Fact Sheet ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

Uptake of Genetic Counseling

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.

Time frame

Change from the baseline survey to four months after baseline

Uptake of Genetic Testing

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.

Time frame

Change from the baseline survey to four months after baseline

Secondary outcomes

Knowledge about HBOC

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.

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

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)

Time frame

Change from the baseline to two-week after baseline

Beliefs and Attitudes about genetic cancer risk assessment

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).

Time frame

Change from the baseline to two-week after baseline

Subjective norms about genetic cancer risk assessment

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)

Time frame

Change from the baseline to two-week after baseline

Other outcomes

Feasibility of the Referral Screening Tool

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?)

Time frame

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

Qualitative measure captured through semi-structured interviews using the Consolidated Framework for Implementation Research.

Time frame

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

Qualitative measure captured through semi-structured interviews using the Consolidated Framework for Implementation Research.

Time frame

At the post implementation focus groups with community clinics adoption over the previous 48 months will be assessed

Sustainability of the Referral Screening Tool

Qualitative measure captured through semi-structured interviews using the Consolidated Framework for Implementation Research.

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Georgetown University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Virginia Commonwealth University

Collaborator

Source ClinicalTrials.gov

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