CONTIGO - A Narrative Intervention to Enhance Genetic Counseling and Testing

NCT05130606 | Recruiting

• 2 other identifiers: STUDY000027891R01CA248543-01A1
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 2

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.

Conditions

Hereditary Breast and Ovarian Cancer

Keywords

Breast cancer; Ovarian cancer; Hereditary cancer; Latinas

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

• Self-efficacy about attending genetic cancer risk assessment

  Change from the baseline to two-week after baseline

• Beliefs and Attitudes about genetic cancer risk assessment

  Change from the baseline to two-week after baseline

• Subjective norms about genetic cancer risk assessment

  Change from the baseline to two-week after baseline

• Anticipatory emotions about genetic cancer risk assessment

  Change from the baseline to two-week after baseline

Other Outcomes (4)

• Feasibility of the Referral Screening Tool

  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

  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

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

Study Arms (2)

Video Arm

EXPERIMENTAL

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."

Fact Sheet Arm

ACTIVE COMPARATOR

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

Interventions

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.

Video Arm

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.

Fact Sheet Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only self-identified women will be recruited for this study
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Georgetown University: lead
• National Cancer Institute (NCI): collaborator
• Virginia Commonwealth University: collaborator

Study Sites (2)

Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

RECRUITING

MeSH Terms

Conditions

Hereditary Breast and Ovarian Cancer Syndrome; Breast Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Neoplastic Syndromes, Hereditary; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Alejandra Hurtado de Mendoza, Ph.D

  Georgetown Lombardi Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alejandra Hurtado de Mendoza, Ph.D

CONTACT

2026878916; ahd28@georgetown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Hybrid Type 1 research design (efficacy study). Two arm randomized controlled trial and Implementation Focused Process Evaluation

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: November 23, 2021
• Study Start: June 1, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)