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

NCT06534424 | Completed

• 2 other identifiers: OSU-17057NCI-2022-07731
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Decisional conflict Regarding Cancer Risk Management

  Decisional conflict regarding cancer risk management will be measured via a questionnaire. Comparison of this measure between the enhanced and standard arms adjusting for stratified randomization will be made using linear regression. The alpha level for the outcome will be 0.05.

  Up to 3 months

Study Arms (2)

Arm I (enhanced risk assessment)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Other: Counseling; Procedure: Discussion; Procedure: Genotyping; Procedure: Molecular Risk Assessment; Other: Questionnaire Administration

Arm II (standard)

ACTIVE COMPARATOR

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

Other: Best Practice; Procedure: Biospecimen Collection; Procedure: Discussion; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Receive standard care

Also known as: standard of care, standard therapy

Arm II (standard)

Biospecimen Collection PROCEDURE

Undergo collection of blood or mouthwash sample

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (enhanced risk assessment); Arm II (standard)

Counseling OTHER

Receive tailored counseling

Also known as: Counseling Intervention

Arm I (enhanced risk assessment)

Discussion PROCEDURE

Participate in phone discussion

Also known as: Discuss

Arm I (enhanced risk assessment); Arm II (standard)

Genotyping PROCEDURE

Undergo genotyping

Also known as: GENOTYPE, Genotype Analysis, Genotype Assay

Arm I (enhanced risk assessment)

Molecular Risk Assessment PROCEDURE

Undergo enhanced risk assessment

Arm I (enhanced risk assessment)

Questionnaire Administration OTHER

Ancillary studies

Arm I (enhanced risk assessment); Arm II (standard)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (2)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Hereditary Breast and Ovarian Cancer Syndrome

Interventions

Practice Guidelines as Topic; Standard of Care; Specimen Handling; Counseling; Genotype

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplastic Syndromes, Hereditary; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Genetic Phenomena

Study Officials

• Amanda E Toland

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start: January 1, 2018
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

US (2)