Randomized Controlled Trial of Patient Navigation for Newly Diagnosed Cancer Patients: Effects on Quality of Life

Background: Patient navigation is a promising intervention to ameliorate cancer health disparities. This study objective was to measure patient navigation effects on cancer-specific quality of life (QOL) among patients with newly diagnosed cancer. Methods: A randomized controlled trial of patient navigation was conducted in Rochester, NY. Patients with breast cancer and colorectal cancer were randomly assigned to receive a patient navigation intervention or usual care. QOL was measured at baseline and four subsequent time points, using the validated Functional Assessment of Cancer Therapy (FACT-B, FACT-C) instruments. Results: Among 319 randomized patients (165 patient navigation, 154 control), median age was 57 years and 32.5% were from minority race/ethnicity groups. Patient navigation and control groups were comparable on baseline factors, except home ownership versus renting (more home ownership among controls, P = 0.05) and race (more whites among controls, P 0.05). Total and subscale FACT scores did not differ between groups when analyzed as a change from baseline to 3 months, or at various time points. The emotional well-being subscale change from baseline approached significance (better change among patient navigation group, P 0.05). Time trends of QOL measures did not differ significantly between groups. Adjustment for baseline patient factors did not reveal a benefit of patient navigation on QOL. Conclusions: In this randomized trial of patient navigation, there was no statistically significant effect on disease-specific QOL. Impact: These results suggest that patient navigation may not affect QOL during cancer treatment, that social/medical support are adequate in this study's setting, or that the trial failed to target patients likely to experience QOL benefit from patient navigation. Cancer Epidemiol Biomarkers Prev; 21(10); 1682-90. (c) 2012 AACR.