Effectiveness of Patient Navigation on Diagnostic Interval, Anxiety, and Satisfaction of Minority Women with Abnormal Mammograms: a Randomized Controlled Trial 1 UMDNJ-New Jersey Medical School 2 UMDNJ-Robert Wood Johnson Medical School 3 Cancer Institute of New Jersey Jeanne Ferrante MD 1, 2, 3, Ping-Hsin Chen PhD 1, Steve Kim MD 1

Background  Delay in breast cancer diagnosis/treatment –Increased tumor size –Advanced disease stage –Poorer survival –Increased anxiety/emotional distress –Most common cause of malpractice lawsuits

Background  Minority women face many potential barriers that hinder timely follow-up of suspicious mammograms  Over 200 patient navigator programs in U.S.  Only 1 randomized controlled trial published –Mostly foreign born, non-English speaking Latino women –Increased follow-up adherence rates and timely diagnostic resolution after an abnormal mammogram.

Purpose  Determine effectiveness of a patient navigator –Improving timeliness to diagnosis –Decreasing anxiety –Increasing satisfaction

Design & Setting  Randomized controlled trial  Urban public academic hospital  454 women with suspicious mammogram (BI-RADS 4 or 5)  May 2005 to April 2007

Patients  Exclusion criteria –Women under age 21 (N=8) –Did not speak English (N=154)  292 Eligible patients  105 agreed to participate –Intervention group (N=55) –Control group (N=50)

Intervention  Patient navigator –Emotional and social support –Scheduling and keeping appointments –Applications for charity care –Connect patients with resources –Facilitated communication with health providers

Patient Navigator  B.A. in social relations  Previous experience –Youth advocate, habilitation counselor, breast cancer support group volunteer  Training –Breast health education –Public speaking skills workshop –Observations with mammography van, radiologists, breast surgeons, oncologists, social workers, financial office –Contacts with other community organizations

Primary Outcome Measures  Diagnostic interval –Time (days) from suspicious mammogram to final pathology report  Change in anxiety –Zung Anxiety Self- Assessment Scale  Patient satisfaction –Satisfaction with Hospital Care Questionnaire

Potential confounding Variables Age Usual source of care Race/ethnicitySmoking Marital status Reason for mammogram Education Previous abnormal mammogram Insurance Personal hx of breast CA Employment Family hx of breast CA

Statistical Analysis  Control vs. Intervention group –Demographic and clinical characteristics  t-test, chi-square, fisher’s exact test –Diagnostic interval  Survival analysis, Kaplan-Meier, log-rank test –Mean anxiety index, change in anxiety  t-test –Mean satisfaction score  t-test

Results  105 women enrolled –55 intervention –50 control  1 lost to f/u (control)  1 went elsewhere for f/u (intervention)  1 dropped out after diagnosis (intervention)

Characteristics  No difference between control and intervention groups  Mean age 50.1 years (s.d. 11.6)  Blacks (59%) and Hispanics (27.6%)  Unmarried (67.7%)  Uninsured (60%)  Unemployed (65.7%)  Screening mammogram (41%)  No family history of breast cancer (80.8%)  No primary care (51.4%)

Results  Benign diagnosis (N=77)  Cancer diagnosis (N=26) –15 in intervention –11 in control –p=0.651

Results p= Days from mammogram to pathology date Proportion without diagnosis intervention- censored control-censored intervention control Kaplan Meier Estimate of Diagnostic Interval p=0.001

Diagnostic Interval P=0.001

Mean Anxiety Index p=0.35p=<0.001

Satisfaction

Conclusion  Patient navigation effective –Improving timely diagnostic resolution –Decreasing anxiety levels –Increasing satisfaction

Limitations  Limitations –Generalizability –Excluded non-English speaking women –Low enrollment rate 36% of eligible

Acknowledgments  Susan G. Komen Breast Cancer Foundation North Jersey Affiliate  Sharyce Reed, patient navigator

In press  Ferrante JM, Chen P, Kim S. The Effect of Patient Navigation on Time to Diagnosis, Anxiety, and Satisfaction in Urban Minority Women with Abnormal Mammograms: a Randomized Controlled Trial. J Urban Health, 2007