Low-Income Women with Abnormal Breast Findings: Results of a Randomized Trial to Increase Rates of Diagnostic Resolution

Background: Timely diagnostic resolution of abnormal breast findings represents a critical step in efforts to reduce breast cancer morbidity and mortality. Yet, follow-up rates among resource poor populations are not optimal. Efforts to mitigate this disparity are needed. We report results of a randomized trial assessing the effectiveness of a patient support and navigation intervention in increasing timely diagnostic resolution of abnormal breast findings among indigent women. Methods: Women (n = 1,708) diagnosed with a breast abnormality at two public hospitals were randomized to an intervention or control group. The intervention, delivered through telephone, involved one call from a professional health worker and multiple calls from a lay health worker. The outcome, timely diagnostic resolution, defined as receipt of a definitive diagnosis (malignant or benign) within 6 months of the index referral, was assessed through medical chart audit. Results: Intent-to-treat analyses revealed no significant effect of the intervention on timely diagnostic resolution. Diagnostic resolution rates were 55% and 56%, respectively, in the intervention and control arms. The significant predictors were method of abnormality identification (odds ratio = 1.50) and location of first scheduled appointment (odds ratio = 0.62). Conclusions: The intervention was not effective in creating change within the County health system. Achieving optimum diagnostic follow-up may require more intensive interventions than the one tested. In addition, system-level rather than patient-level interventions may hold more promise. Impact: There are no randomized trials reported in the literature testing interventions to increase diagnostic follow-up of breast abnormalities. Future research might test patient and system-level interventions that can be sustained beyond the study period. Cancer Epidemiol Biomarkers Prev; 19(8); 1927-36. (C) 2010 AACR.