BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome
Conditions
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.
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.
Interventions
OTHERBest Practice
Receive standard care
PROCEDUREBiospecimen Collection
Undergo collection of blood or mouthwash sample
OTHERCounseling
Receive tailored counseling
PROCEDUREDiscussion
Participate in phone discussion
PROCEDUREGenotyping
Undergo genotyping
PROCEDUREMolecular Risk Assessment
Undergo enhanced risk assessment
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decisional conflict Regarding Cancer Risk Management | Up to 3 months | 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. |
Countries
United States
Outcome results
None listed