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Enhance the Use of Genetic Counseling and Testing in Latinas

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Georgetown University

Status

Completed

Conditions

Hereditary Breast and Ovarian Cancer Syndrome

Treatments

Other: FORCE Fact Sheet
Behavioral: Culturally-Targeted Video

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04544501
STUDY00001436

Details and patient eligibility

About

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).

Full 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.

Enrollment

61 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

61 participants in 2 patient groups

Culturally-Targeted Video
Experimental group
Treatment:
Behavioral: Culturally-Targeted Video
FORCE Fact Sheet
Active Comparator group
Treatment:
Other: FORCE Fact Sheet

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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