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Trial Title:
Clinical Impact of Enhanced Risk Assessments in Women With a BRCA1/2 Mutation, CARE Study
NCT ID:
NCT06534424
Condition:
BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome
Conditions: Official terms:
Hereditary Breast and Ovarian Cancer Syndrome
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Best Practice
Description:
Receive standard care
Arm group label:
Arm II (standard)
Other name:
standard of care
Other name:
standard therapy
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of blood or mouthwash sample
Arm group label:
Arm I (enhanced risk assessment)
Arm group label:
Arm II (standard)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Other
Intervention name:
Counseling
Description:
Receive tailored counseling
Arm group label:
Arm I (enhanced risk assessment)
Other name:
Counseling Intervention
Intervention type:
Procedure
Intervention name:
Discussion
Description:
Participate in phone discussion
Arm group label:
Arm I (enhanced risk assessment)
Arm group label:
Arm II (standard)
Other name:
Discuss
Intervention type:
Procedure
Intervention name:
Genotyping
Description:
Undergo genotyping
Arm group label:
Arm I (enhanced risk assessment)
Other name:
GENOTYPE
Other name:
Genotype Analysis
Other name:
Genotype Assay
Intervention type:
Procedure
Intervention name:
Molecular Risk Assessment
Description:
Undergo enhanced risk assessment
Arm group label:
Arm I (enhanced risk assessment)
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Arm I (enhanced risk assessment)
Arm group label:
Arm II (standard)
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Facility:
Name:
Huntsman Cancer Institute/University of Utah
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Start date:
January 1, 2018
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Ohio State University Comprehensive Cancer Center
Agency class:
Other
Source:
Ohio State University Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06534424
http://cancer.osu.edu
