personalized risk assessment and decision support for breast cancer prevention
DESCRIPTION
2012 Summer Medical Editors Meeting: Karen Carlson, MDTRANSCRIPT
Personalized Risk Assessment and Personalized Risk Assessment and Decision Support for Breast Cancer Decision Support for Breast Cancer
Prevention Prevention Elissa Ozanne, PhD
Zehra Omer
Karen Carlson, MD
July 30, 2012
USPSTF recommendations
The USPSTF recommends that women whose family history is associated with an increased risk for deleterious mutations in BRCA1 or BRCA2 genes be referred for genetic counseling and evaluation for BRCA testing. Grade: B Recommendation.
The USPSTF recommends that clinicians discuss chemoprevention for women at high risk for breast cancer and at low risk for adverse effects of chemoprevention. Clinicians should inform patients of the potential benefits and harms of chemoprevention.
Grade: B Recommendation
Interventions to reduce breast cancer risk
Lifestyle factors Exercise Avoid weight gain Limit alcohol
Chemoprevention Tamoxifen Raloxifene
Study GoalsStudy Goals
Provide decision support around breast cancer prevention for providers and patients in the primary care setting Automated Risk Assessment Personalized web-based decision aid
Evaluate the feasibility and efficacy of the decision support in the primary care setting Patients Provider
Study Design Study Design
Design Prospective, two-arm, randomized clinical trial Provider unit of randomization
Setting Specialized Women’s Primary Care Clinic
Outcomes Primary: Discussions about risk reduction Secondary: Provider satisfaction
Patient acceptance of decision aid
Patient knowledge and risk perception
Patient decisions
Study SchemaStudy Schema
Post-visit surveys(patient and provider)
Recruitment from Women’s Health Associates (N=120 patients)
Control Group:Standard visit
Intervention Group 2:Risk report
Decision aid during visit
Patient risk information collectedPre-visit surveys completed
Intervention Group1:Risk report
Decision aid before visit
6-month follow-up surveys(patient only)
Intervention Intervention
Risk Report Risk Report given to provider before each visit Patient 5-year and lifetime risk estimates
• Gail, BRCAPRO, Claus models used
Comparison to average women in age group Recommendations for referrals
Decision aidDecision aid Web-based decision aid personalized to patient age and
breast cancer risk assessment
Designed with input from multidisciplinary team Statisticians, clinicians, patient advocates
Risk ReportRisk Report
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Decision Aid OverviewDecision Aid Overview
Patient Demographics Patient Demographics
Well educated ~40% graduate Insured population 100% insured Relatively affluent majority income > $100,000 Majority White 92% Average age mean 52 (40-65 range)
Subjects comparable in both arms other than: Numeracy – Slightly higher in control group Race – Fewer whites in control group
Primary Outcome: Primary Outcome: Discussion about Risk ReductionDiscussion about Risk Reduction
The intervention group had at least a 3 fold increase in discussions about risk assessment during the consultation
Primary Outcome: Primary Outcome: Discussion about Risk ReductionDiscussion about Risk Reduction
Acceptability and SatisfactionAcceptability and Satisfaction
Patients found the decision aid: Helpful (97%) Easy to use (88%) Worth recommending to others (100%) Impacted their decision (79%)
Providers were equally satisfied with control and intervention visits
Patient Referrals and Patient Referrals and AppointmentsAppointments
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Patient DecisionsPatient Decisions
Patient decisions regarding lifestyle risk reduction options
“Patient has lost 10 pounds and is motivated to lose weight, has joined Weight Watchers” (from next visit note with PCP)
“She recently joined gym, lost 6 pounds and started to limit her alcohol intake” (from visit note at the high risk clinic)
“Patient will try to limit her alcohol intake to two glasses per day” (from visit note at the high
risk clinic)
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ConclusionsConclusions
Risk assessment alone is enough to encourage a discussion about breast cancer risk reduction for some providers
Decision aid was useful in only certain circumstances Clinician “super users” Lifestyle interventions Patients at high risk without acute issues
Breast cancer risk discussion may motivate patients to adopt lifestyle interventions that are beneficial to their general health
Future Research DirectionsFuture Research Directions
External generalizability Study impact in diverse group of providers and patients
• Athena Breast Health Network – UC medical centers
Assessing wider clinical impact Risk assessment to tailor mammography recommendations Patients’ motivation for lifestyle interventions How to encourage tamoxifen use in appropriate women
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Decision Aid Scientific Advisory Decision Aid Scientific Advisory BoardBoard
Development team Elissa Ozanne, PhD Laura Esserman, MD, MBA Tom Bechtold
Statisticians Mitchell Gail, MD, PhD Joseph Costantino, DrPH
Surgeons David Euhus, MD, FACS Kevin Hughes, MD Victor Vogel, MD Michael Alvarado, MD
Psychologist Elyse Park, PhD, MPH
Oncologists Carol Fabian, MD Judy Garber, MD, MPH Paula Ryan, MD, PhD Joyce O’Shaughnessy, MD
Primary Care Physicians Karen Carlson, MD Nancy Keating, MD, MPH Mary Beattie, MD, MPH
Genetic Counselors Beth Crawford, MS Jennifer Klemp, MPH, PhD
Patient advocates