CompletedNot Applicable

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

United States152 participantsStarted 2018-01-01

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Have had genetic counseling and testing for mutations in BRCA1 and/or BRCA2 through a Clinical Laboratory Improvement Act (CLIA)-certified laboratory * Were found to have a known pathogenic mutation upon testing * Are within 3 weeks of results disclosure * Have available medical records for ascertainment of clinical information * Are able to provide a source of deoxyribonucleic acid (DNA) (blood or mouthwash) for study * Have access to a telephone and a computer or other internet-ready device * Have not yet had a bilateral prophylactic mastectomy or bilateral Salpingo oophorectomy

What they're measuring

Decisional conflict Regarding Cancer Risk Management

Timeframe: Up to 3 months

Trial details

NCT IDNCT06534424

SponsorOhio State University Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-30

View on ClinicalTrials.gov More BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome trials