A Randomized Controlled Trial of the Integrated Cancer Care Access Network on Cancer Treatment Completion and Quality of Life.

Abstract

Background: We prospectively examined the effect of a multilingual, multidisciplinary patient navigation and essential needs access program on oncology treatment completion and patient-reported outcomes among medically underserved patients with cancer. Medically underserved patients have limited socioeconomic/geographic access to medical care.

Patients and methods: We conducted an unblinded, 2-arm randomized controlled trial among patients with stage I-III cancer at 2 New York City safety-net cancer clinics (2013-2016), where social work and appointment navigation support were generally available. Patients were randomized by permuted block to either the Integrated Cancer Care Access Network (ICCAN) intervention or the institution's usual and customary care (U&C). The primary outcome, treatment completion, was assessed at 12 months. Quality of life (EuroQol 5-Dimension [EQ-5D]), depression symptoms (Patient Health Questionnaire-9 [PHQ-9]), and stress (4-item Perceived Stress Scale [PSS-4]) scores were assessed at baseline and 12 months.

Results: All 152 participants were assessed for the primary outcome (ICCAN, n=76; U&C, n=76). Most patients (57%) were foreign-born; 64% preferred English, and 36% preferred Spanish. Treatment completion was higher in the ICCAN arm compared with the U&C arm (92% vs 78%; P=.022). Both arms showed improvements in EQ-5D (effect sizes [ES]: U&C, 0.75; ICCAN, 1.47), PHQ-9 (U&C, 1.06; ICCAN, 1.33), and PSS-4 scores (U&C, 0.29; ICCAN, 1.13). Improvements in EQ-5D (P=.001), PHQ-9 (P=.046), and PSS-4 (P=.001) scores were significantly greater among patients in the ICCAN arm.

Conclusions: Patients in the ICCAN arm had significantly better treatment completion and patient-reported outcomes than those receiving U&C. Future studies should explore service utilization and resource access to clarify the reasons for these differences. Comprehensive multidisciplinary patient navigation may improve outcomes for underserved patients with cancer.

Clinicaltrials: gov identifier: NCT01742143.