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

START

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