Enhance the Use of Genetic Counseling and Testing in Latinas

A Randomized Controlled Trial to Enhance the Use of Genetic Counseling and Testing in Latinas

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).

Study Overview

• Status: Completed
• Conditions: Hereditary Breast and Ovarian Cancer Syndrome
• Intervention / Treatment: Behavioral: Culturally-Targeted Video; Other: FORCE Fact Sheet

Detailed Description

The investigators will conduct a two-arm RCT to evaluate the preliminary effectiveness of a culturally-adapted video developed by the team vs. 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).

All participants will receive referrals to free telephone genetic counseling in Spanish to address cost, pragmatic, and language barriers. The investigators will recruit 28 Latina women at-risk of HBOC (14 randomized at each arm) at three sites with sizable Latinx populations. The sites include community clinics/health organizations and hospitals with whom we have established collaborations [Georgetown University (DC); Virginia Commonwealth University (VA)].

Results will improve efforts to translate genomic guidelines into practice and will reduce disparities by evaluating a low cost highly disseminable culturally-targeted video while gathering data on effectiveness and implementation.

Aim 1. Evaluate the impact of video vs. FORCE fact sheet on GCRA and testing uptake and psychosocial outcomes.

Aim 2. Assess implementation potential and needs by evaluating feasibility, acceptability, reach, and adoption of the intervention arms (video and FORCE fact sheet) and of the HBOC screening process at the community clinics.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20003
      • Capital Breast Care Center
  • Virginia
    • Alexandria, Virginia, United States, 22314
      • Nueva Vida
    • Arlington, Virginia, United States, 22204
      • Arlington Free Clinic
    • Richmond, Virginia, United States, 23284
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Culturally-Targeted Video	Behavioral: Culturally-Targeted Video; 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.
Active Comparator: FORCE Fact Sheet	Other: FORCE Fact Sheet; A publically available Spanish-language fact sheet about HBOC and GCRA developed by FORCE.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Genetic testing uptake	Proportion of participants that receive genetic testing. The outcome will be assessed by self-report (e.g., Have you received genetic testing in the past three months?) and confirmed with the genetic counseling company records.	Baseline survey to three months after baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast cancer genetics knowledge	Change in knowledge about HBOC and GCRA. Knowledge will be measured using a 13-item Erblich et al., 2005 scale about genetic knowledge about breast cancer. 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 0-13.	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	Change in intentions to participate in genetic counseling and genetic testing. A 2-item scale developed by Sussner, Jandorf, Thompson, and Valdimarsdottir, 2010 will be used to assess intentions to participate in genetic counseling and testing. Participants respond to a Likert-trype scale from 1 (Not at all) to 5 (Very) how likely it is that they will participate in genetic counseling and testing in the next three months.	Baseline to two weeks after baseline
Beliefs and attitudes about genetic counseling and genetic testing	Changes in beliefs and attitudes about genetic counseling and genetic testing. The outcome will be assessed by a 30-item scale developed by Sussner, Jandorf, Thompson et al., 2012 in which participants respond to a Likert-type scale from 1 (completely disagree) to 7 (complete agree).	Baseline to two weeks after baseline
Anticipatory Emotions	Changes in anticipatory emotions about receive genetic counseling. Assessed by participants' responses to how they feel 'right now' about the specific behavior of receiving genetic counseling and testing in the next three months. Responses are in a 7-point Likert-type form (from 1-strongly disagree to 7-strongly agree).	Baseline to two weeks after baseline

Collaborators and Investigators

• Sponsor: Georgetown University
• Collaborators: Virginia Commonwealth University; Basser Center for BRCA; Nueva Vida, Inc.; Capital Breast Care Center; Arlington Free Clinic
• Investigators: Principal Investigator: Alejandra Hurtado de Mendoza, Ph.D, Georgetown University

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2020
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: June 18, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (Actual): September 10, 2020

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 25, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Latinas; Intervention
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Breast Diseases; Genetic Diseases, Inborn; Neoplastic Syndromes, Hereditary; Ovarian Neoplasms; Breast Neoplasms; Hereditary Breast and Ovarian Cancer Syndrome
• Other Study ID Numbers: STUDY00001436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No