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Clinical Impact of Enhanced Risk Assessments in Women With a BRCA1/2 Mutation, CARE Study

NCT06534424 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2025-06-27

No results posted yet for this study

Summary

This clinical trial evaluates the impact of enhanced risk assessments on knowledge, perceptions, and decisional conflict about cancer prevention in women with a BRCA1 or BRCA2 mutation. BRCA1/2 mutation carriers have a much higher risk of developing breast and ovarian cancer. Due to the high risk of cancer, mutation carriers are provided guidelines on more intensive screening and preventative surgeries such as bilateral mastectomy and bilateral salpingo-oophorectomy. Doctors want to learn if a more personalized risk assessment impacts the patients' risk perceptions and comfort with decision-making around cancer prevention behaviors.

Conditions

  • BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome

Interventions

OTHER

Best Practice

Receive standard care

PROCEDURE

Biospecimen Collection

Undergo collection of blood or mouthwash sample

OTHER

Counseling

Receive tailored counseling

PROCEDURE

Discussion

Participate in phone discussion

PROCEDURE

Genotyping

Undergo genotyping

PROCEDURE

Molecular Risk Assessment

Undergo enhanced risk assessment

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Amanda E Toland · Ohio State University Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06534424 on ClinicalTrials.gov