Enhance the Use of Genetic Counseling and Testing in Latinas

Hereditary Breast and Ovarian Cancer Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04544501
• Other study ID #: STUDY00001436
• Status: Completed
• Phase: N/A
• Start date: February 24, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: December 2021
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hereditary Breast and Ovarian Cancer Syndrome

Intervention

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.

Other:
• FORCE Fact Sheet
A publically available Spanish-language fact sheet about HBOC and GCRA developed by FORCE.

Locations

Country	Name	City	State
United States	Nueva Vida	Alexandria	Virginia
United States	Arlington Free Clinic	Arlington	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Capital Breast Care Center	Washington	District of Columbia

Sponsors (6)

Lead Sponsor	Collaborator
Georgetown University	Arlington Free Clinic, Basser Center for BRCA, Capital Breast Care Center, Nueva Vida, Inc., Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	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