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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2023-09-30

Brief Summary

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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.

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Detailed Description

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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

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BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Arm I (enhanced risk assessment)

Patients undergo collection of blood or mouthwash samples. 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.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood or mouthwash sample

Counseling

Intervention Type OTHER

Receive tailored counseling

Discussion

Intervention Type PROCEDURE

Participate in phone discussion

Genotyping

Intervention Type PROCEDURE

Undergo genotyping

Molecular Risk Assessment

Intervention Type PROCEDURE

Undergo enhanced risk assessment

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Arm II (standard)

Patients undergo collection of blood or mouthwash samples. 4-8 weeks later, patients receive a standard follow-up phone call.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive standard care

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood or mouthwash sample

Discussion

Intervention Type PROCEDURE

Participate in phone discussion

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Best Practice

Receive standard care

Intervention Type OTHER

Biospecimen Collection

Undergo collection of blood or mouthwash sample

Intervention Type PROCEDURE

Counseling

Receive tailored counseling

Intervention Type OTHER

Discussion

Participate in phone discussion

Intervention Type PROCEDURE

Genotyping

Undergo genotyping

Intervention Type PROCEDURE

Molecular Risk Assessment

Undergo enhanced risk assessment

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy Biological Sample Collection Biospecimen Collected Specimen Collection Counseling Intervention Discuss GENOTYPE Genotype Analysis Genotype Assay

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No