Clinical trial NCT04544501: Enhance the Use of Genetic Counseling and Testing in Latinas
Official title: A Randomized Controlled Trial to Enhance the Use of Genetic Counseling and Testing in Latinas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hereditary Breast and Ovarian Cancer Syndrome
Keywords: Latinas
Intervention
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: Basser Center for BRCA
name: Nueva Vida, Inc.
name: Capital Breast Care Center
name: Virginia Commonwealth University
name: Arlington Free Clinic
First posted: 2020-09-10
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Genetic counseling uptake
timeFrame: Baseline survey to three months after baseline
Secondary outcomes:
measure: Genetic testing uptake
timeFrame: Baseline survey to three months after baseline
Other outcomes:
measure: Breast cancer genetics knowledge
timeFrame: Change from baseline to two weeks after baseline and change from baseline to three months after baseline
measure: Intentions to participate in genetic counseling and genetic testing
timeFrame: Baseline to two weeks after baseline
measure: Beliefs and attitudes about genetic counseling and genetic testing
timeFrame: Baseline to two weeks after baseline
measure: Anticipatory Emotions
timeFrame: Baseline to two weeks after baseline
Locations:
city: Washington
country: United States
facility: Capital Breast Care Center
state: District of Columbia
city: Alexandria
country: United States
facility: Nueva Vida
state: Virginia
city: Arlington
country: United States
facility: Arlington Free Clinic
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Georgetown University
name: Alejandra Hurtado de Mendoza, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: