Enhance the Use of Genetic Counseling and Testing in Latinas
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|ClinicalTrials.gov Identifier: NCT04544501|
Recruitment Status : Enrolling by invitation
First Posted : September 10, 2020
Last Update Posted : September 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hereditary Breast and Ovarian Cancer Syndrome||Behavioral: Culturally-Targeted Video Other: FORCE Fact Sheet||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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.
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial to Enhance the Use of Genetic Counseling and Testing in Latinas|
|Actual Study Start Date :||February 24, 2020|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||April 2021|
|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.
- Genetic counseling uptake [ Time Frame: 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.
- Genetic testing uptake [ Time Frame: 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.
- Breast cancer genetics knowledge [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04544501
|United States, District of Columbia|
|Capital Breast Care Center|
|Washington, District of Columbia, United States, 20003|
|United States, Virginia|
|Alexandria, Virginia, United States, 22314|
|Arlington Free Clinic|
|Arlington, Virginia, United States, 22204|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23284|
|Principal Investigator:||Alejandra Hurtado de Mendoza, Ph.D||Georgetown University|