Overall survival (OS) and healthcare utilization results of a randomized controlled trial (RCT) assessing a patient navigation (PN) intervention to increase early access to supportive care (SC) for patients with metastatic cancer in a resource-limited setting.
Authors: Araujo Miguel , Chavarri Guerra Yanin , Ramos-López Wendy A , Alcalde Castro Mirza , Covarrubias-Gómez Alfredo , Quiroz Paulina , Sánchez-Román Sofía , Alcocer Natasha , Navarro-Lara Africa , Bolano Guerra Laura Margarita , Chavarri Maldonado Juan Alberto , Medina-Palma Mildred E , Torres ANA Cristina , Aguilar Velazco Jose Carlos , Hernandez-Gilsoul Thierry , Krush Lindsay , Goss Paul , Soto Perez De Celis Enrique 
Published: May 2020

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Background: We previously reported improvements in access to SC, advance directive completion, and pain control in a RCT comparing a patient navigator-led early SC intervention vs. usual care among patients with newly-diagnosed metastatic cancer in Mexico (NCT03293849). We now present results on healthcare utilization and OS. Methods: Patients were randomized to PN or usual oncology care. Patients in the PN arm received SC interventions by a navigator-led multidisciplinary team (palliative care, physical therapy, geriatrics, psychology) in the first 12 weeks after diagnosis. At 12-weeks, patients allocated to usual care were able to cross-over to PN and receive multidisciplinary SC. We analyzed the number (no.) of emergency room (ER) visits, their cause, and whether they were potentially avoidable (as determined by expert consensus), using descriptive statistics and X2 tests. OS was estimated using the Kaplan-Meier method and the log-rank test. Results: 133 patients (median age 60, range 23-93; 52% male) were randomized (66 PN, 67 control) from 08/17 to 04/18. Median follow-up was 22.8 months. 61% had gastrointestinal tumors, and 45% had a calculated life expectancy ≤6 months. 69% of patients randomized to usual care crossed-over to PN and received SC interventions. 80% of patients attended the ER ≥once (median no. of visits = 2). No difference was found between patients randomized to early SC or usual care in ER visits (2.4 vs. 2.3, p = 0.58). Out of a total 316 ER visits, the most common reason was infections (n = 69, 22%), followed by pain (n = 40, 13%), and indwelling catheter-related complications (n = 23, 7%). 41% of ER visits were considered as potentially avoidable, with no difference in avoidable visits found between arms (1.7 vs. 1.7, p = 0.49). No differences between arms were found in no. of hospitalizations (0.8 vs. 0.6 p = 0.82). Survival results were assessed after 64% of patients had died (n = 85), finding no statistically significant OS difference between the early SC intervention and the usual care arms (11.0 vs 13.0 months, p = 0.77) Conclusions: In the context of a limited-resource healthcare system, the early delivery of SC did not improve healthcare utilization, reduce avoidable ER visits, or prolong OS compared to the implementation of SC at a later time, which might be partially explained by the unavailability of hospice or home care, and by high rates of cross-over between arms. Clinical trial information: NCT03293849 .