Enhance the Use of Genetic Counseling and Testing in Latinas

Sponsor

Georgetown University (Other)

Overall Status

Completed

CT.gov ID

NCT04544501

Collaborator

Basser Center for BRCA (Other), Nueva Vida, Inc. (Industry), Capital Breast Care Center (Other), Virginia Commonwealth University (Other), Arlington Free Clinic (Other)

Enrollment

Locations

Arms

23.2

Actual Duration (Months)

15.3

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Hereditary Breast and Ovarian Cancer Syndrome	Behavioral: Culturally-Targeted Video Other: FORCE Fact Sheet	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 24, 2020

Actual Primary Completion Date :

Jan 31, 2022

Actual Study Completion Date :

Jan 31, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Genetic counseling uptake [Baseline survey to three months after baseline]
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.

Secondary Outcome Measures

Genetic testing uptake [Baseline survey to three months after baseline]
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.

Other Outcome Measures

Breast cancer genetics knowledge [Change from baseline to two weeks after baseline and change from baseline to three months after baseline]
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.
Intentions to participate in genetic counseling and genetic testing [Baseline to two weeks after baseline]
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.
Beliefs and attitudes about genetic counseling and genetic testing [Baseline to two weeks after baseline]
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).
Anticipatory Emotions [Baseline to two weeks after baseline]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Capital Breast Care Center	Washington	District of Columbia	United States	20003
2	Nueva Vida	Alexandria	Virginia	United States	22314
3	Arlington Free Clinic	Arlington	Virginia	United States	22204
4	Virginia Commonwealth University	Richmond	Virginia	United States	23284

Sponsors and Collaborators

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

Investigators

Principal Investigator: Alejandra Hurtado de Mendoza, Ph.D, Georgetown University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Georgetown University

ClinicalTrials.gov Identifier:

NCT04544501

Other Study ID Numbers:

STUDY00001436

First Posted:

Sep 10, 2020

Last Update Posted:

May 2, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Georgetown University

Latinas

Intervention

Additional relevant MeSH terms:

Hereditary Breast and Ovarian Cancer Syndrome

Study Results

No Results Posted as of May 2, 2022