CONTIGO - Informing Latinas About HBOC Risk

Hereditary Breast and Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05130606
• Other study ID #: STUDY00002789
• Secondary ID: 1R01CA248543-01A
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 332
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Hereditary Breast and Ovarian Cancer
• Hereditary Breast and Ovarian Cancer Syndrome
• Ovarian Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Georgetown Lombardi Comprehensive Cancer Center	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Georgetown University	National Cancer Institute (NCI), Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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?)	Change from the pre-implementation focus groups with community clinics to post implementation focus groups with community clinics (48 months)
Other	Acceptability of the Referral Screening Tool	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)
Other	Adoption of the Referral Screening Tool	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
Other	Sustainability of the Referral Screening Tool	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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