Enhance the Use of Genetic Counseling and Testing in Latinas

NCT04544501 | Completed

• 1 other identifier: STUDY00001436
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 4

Brief Summary

The investigators will conduct a two-arm RCT to evaluate the preliminary effectiveness of a culturally-adapted video developed by the team vs. a FORCE fact sheet on enhancing genetic cancer risk assessment (GCRA; including genetic counseling and option for genetic testing) uptake and psychosocial outcomes among Latinas at increased risk for hereditary breast and ovarian cancer (HBOC).

Conditions

Hereditary Breast and Ovarian Cancer Syndrome

Keywords

Latinas; Intervention

Outcome Measures

Primary Outcomes (1)

• Genetic counseling uptake

  Proportion of participants that receive genetic counseling. The outcome will be assessed by self-report (e.g., Have you received genetic counseling in the past three months?) and confirmed with the genetic counseling company records.

  Baseline survey to three months after baseline

Secondary Outcomes (1)

• Genetic testing uptake

  Baseline survey to three months after baseline

Other Outcomes (4)

• Breast cancer genetics knowledge

  Change from baseline to two weeks after baseline and change from baseline to three months after baseline

• Intentions to participate in genetic counseling and genetic testing

  Baseline to two weeks after baseline

• Beliefs and attitudes about genetic counseling and genetic testing

  Baseline to two weeks after baseline

Study Arms (2)

Culturally-Targeted Video

EXPERIMENTAL

Behavioral: Culturally-Targeted Video

FORCE Fact Sheet

ACTIVE COMPARATOR

Other: FORCE Fact Sheet

Interventions

Culturally-Targeted Video BEHAVIORAL

Culturally targeted narrative video: "Is My Cancer Hereditary? Rosa Visits a Genetic Counselor." With R03 funding (R03CA191543) we developed a culturally targeted narrative video for at-risk Latinas. A multidisciplinary team of researchers collaborated with filmmakers to develop the script and video. The script was informed by health behavior conceptual models, evidence-based risk communication strategies, and formative research (40 interviews with providers and at-risk Latinas). The script addressed identified knowledge gaps (e.g., incorrect belief that pap smears screen for ovarian cancer), facilitators (e.g., inform family cancer risk), barriers (e.g., emotional concerns), and cultural factors (e.g., respect). The 18-minute video illustrates the GCRA process with the story of Rosa, a Latina cancer survivor at increased risk of HBOC. Rosa learns about HBOC risk factors, overcomes barriers, and attends genetic counseling.

Culturally-Targeted Video

FORCE Fact Sheet OTHER

A publically available Spanish-language fact sheet about HBOC and GCRA developed by FORCE.

FORCE Fact Sheet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than 18 years-old
• Self-identify as Latina
• Fluent in Spanish
• Meet NCCN criteria for breast and/or ovarian genetic cancer risk assessment based on -personal or family history of cancer
• Have not received genetic counseling or genetic testing
• Able to provide informed consent
• No other members of the same family have participated
• Must have access to the internet via smartphone, computer, or another device.

You may not qualify if:

• Not fluent in Spanish
• Previously received genetic counseling or genetic testing for HBOC
• Previously participated in another interventional study about HBOC and GCRA

Sponsors & Collaborators

• Georgetown University: lead
• Basser Center for BRCA: collaborator
• Nueva Vida, Inc.: collaborator
• Capital Breast Care Center: collaborator
• Virginia Commonwealth University: collaborator
• Arlington Free Clinic: collaborator

Study Sites (4)

Capital Breast Care Center

Washington D.C., District of Columbia, 20003, United States

Location

Nueva Vida

Alexandria, Virginia, 22314, United States

Location

Arlington Free Clinic

Arlington, Virginia, 22204, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

MeSH Terms

Conditions

Hereditary Breast and Ovarian Cancer Syndrome

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Ovarian 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 University

  PRINCIPAL INVESTIGATOR

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: 28 Latina women at risk for HBOC will be randomly assigned to one arm after completing the baseline assessment. We will conduct a Hybrid Type 1 design to (1) test the effectiveness of two intervention approaches (video vs. FORCE fact sheet) in enhancing GCRA uptake and psychosocial outcomes and to (2) collect data on implementation outcomes regarding the interventions (video vs. FORCE fact sheet) and the implementation of a short screening survey to identify at-risk women. Given the hybrid design, we will also conduct focus groups with clinic staff, in which we estimate 32 staff to participate. Given their participation in the focus groups, clinic staff are also considered participants, but they are not part of the randomized trial.

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: September 10, 2020
• Study Start: February 24, 2020
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: May 2, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)