CONTIGO - Informing Latinas About HBOC Risk

Study Overview
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Brief Summary
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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
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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.

Official Title
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CONTIGO - Informing Latinas About HBOC Risk: a Randomized Controlled Trial

Conditions
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Hereditary Breast and Ovarian Cancer

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


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Hybrid Type 1 research design (efficacy study). Two arm randomized controlled trial and Implementation Focused Process Evaluation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Video Arm<br>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.<br>* 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.<br>|
| Active Comparator: Fact Sheet Arm<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Change from the baseline survey to four months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 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). | 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) | Change from the baseline to two-week after baseline | 
| Anticipatory emotions about genetic cancer risk assessment | 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 | 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 | Proportion of women who have watched/read the video or fact sheet at the two week follow up | At two weeks after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Ovarian cancer, Hereditary cancer, Latinas