A cluster randomized trial evaluating the efficacy of patient navigation in improving quality of diagnostic care for patients with breast or colorectal cancer abnormalities.

BACKGROUND: This study examines efficacy of a lay patient navigation (PN) program aimed to reduce time between a cancer abnormality and definitive diagnosis among racially/ethnically diverse and medically underserved populations of Tampa Bay, Florida.
METHODS: Using a cluster randomized design, the study consisted of 11 clinics (six navigated; five control). Patients were navigated from time of a breast or colorectal abnormality to diagnostic resolution, and to completion of cancer treatment. Using a generalized mixed-effects model to assess intervention effects, we examined: (i) length of time between abnormality and definitive diagnosis, and (ii) receipt of definitive diagnosis within the 6-month minimum follow-up period.
RESULTS: A total of 1,267 patients participated (588 navigated; 679 control). We also included data from an additional 309 chart abstractions (139 navigated arm; 170 control arm) that assessed outcomes at baseline. PN did not have a significant effect on time to diagnostic resolution in multivariable analysis that adjusted for race-ethnicity, language, insurance status, marital status, and cancer site (P = 0.16). Although more navigated patients achieved diagnostic resolution by 180 days, results were not statistically significant (74.5% navigated vs. 68.5% control, P = 0.07).
CONCLUSIONS: PN did not impact the overall time to completion of diagnostic care or the number of patients who reached diagnostic resolution of a cancer abnormality. Further evaluation of PN programs applied to other patient populations across the cancer continuum is necessary to gain a better perspective on its effectiveness. IMPACT: PN programs may not impact timely resolution of an abnormality suspicious of breast or colorectal cancer. 2012 AACR

RCT Entities:   Population Interventions Outcomes