NCT06534424

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

The caRe Study: Clinical Application of Refined Risk Estimates

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To deploy tools for delivering enhanced genetic risk predictions based on BRCA1/2 genetic risk modifiers in a clinical setting and assess the impact of risk stratification on genetic knowledge, risk perceptions and decisional conflict regarding cancer prevention decision-making. II. To perform long-term follow-up of individuals in the randomized controlled trial (RCT) to determine if there are differences in satisfaction, decision-making and outcomes in individuals who received standard versus enhanced genetic risk predictions over time. OUTLINE: Patients undergo collection of blood or mouthwash samples. Patients are then randomized to 1 of 2 arms. ARM I: Patients undergo genotyping with enhanced risk assessment on study. 4 to 8 weeks later, patients receive a follow-up phone call for return of enhanced risk assessment results and tailored counseling. ARM II: 4-8 weeks later, patients receive a standard follow-up phone call. After completion of study intervention, patients are followed up for 2 years.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-01-01
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2024-08-02
• Last updated: 2025-06-27

Locations

2 sites across 1 country: United States