2012 Summer Medical Editors Meeting: Karen Carlson, MD

1. Personalized Risk Assessment and
Decision Support for Breast Cancer
Prevention
Elissa Ozanne, PhD
Zehra Omer
Karen Carlson, MD
July 30, 2012

2. 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

3. Interventions to reduce breast
cancer risk
 Lifestyle factors
 Exercise
 Avoid weight gain
 Limit alcohol
 Chemoprevention
 Tamoxifen
 Raloxifene

4. Study 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

5. 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

6. Study Schema
Recruitment from Women’s Health Associates
(N=120 patients)
Patient risk information collected
Pre-visit surveys completed
Intervention Group1:
Intervention Group 2:
Control Group: Risk report
Risk report
Standard visit Decision aid before visit
Decision aid during visit
Post-visit surveys
(patient and provider)
6-month follow-up surveys
(patient only)

7. Intervention
 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 aid
 Web-based decision aid personalized to patient age and
breast cancer risk assessment
 Designed with input from multidisciplinary team
 Statisticians, clinicians, patient advocates

8. Risk Report

9. Decision Aid Overview
START

11. 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

12. Primary Outcome:
Discussion about Risk Reduction
The intervention group had at least a 3 fold increase in
discussions about risk assessment during the consultation

13. Primary Outcome:
Discussion about Risk Reduction

14. Acceptability 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

15. Patient Referrals and
Appointments
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16. Patient 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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17. Conclusions
 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

18. Future 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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19. Decision Aid Scientific Advisory
Board
Development team Oncologists
 Elissa Ozanne, PhD  Carol Fabian, MD
 Laura Esserman, MD, MBA  Judy Garber, MD, MPH
 Tom Bechtold
 Paula Ryan, MD, PhD
 Joyce O’Shaughnessy, MD
Statisticians
 Mitchell Gail, MD, PhD
 Joseph Costantino, DrPH Primary Care Physicians
 Karen Carlson, MD
Surgeons  Nancy Keating, MD, MPH
 David Euhus, MD, FACS  Mary Beattie, MD, MPH
 Kevin Hughes, MD
 Victor Vogel, MD
Genetic Counselors
 Michael Alvarado, MD  Beth Crawford, MS
 Jennifer Klemp, MPH, PhD
Psychologist
 Elyse Park, PhD, MPH
Patient advocates
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