Intervention combining nurse navigators (NNs) and a mobile application versus standard of care (SOC) in cancer patients (pts) treated with oral anticancer agents (OAA): Results of CapRI, a single-center, randomized phase III trial.

Abstract

2000 Background: Various interventions aiming to improve a safe use of oral anti-cancer agents have previously been reported. These retrospective studies involved nurse-led follow-up and use of health technologies. However, the potential impact of these combined strategies is limited by a lack of rigorous methodology. Methods: We performed a randomized phase 3 trial comparing an intervention combining NNs and a mobile application vs. SOC in cancer pts treated with OAA (excluding hormonal therapy) in our tertiary cancer center. Pts initiating OAA (all types of cancer, PS < 3, life expectancy > 6 months), were randomized in a 1:1 basis. The intervention combined a nursing-led follow-up and a mobile application for patients. NNs provided regular phone follow-ups to manage symptoms and assess toxicities, adherence and supportive care needs. Pts had access to a mobile application to record tracking data, contact NNs via secure messaging or a dedicated phone line. The intervention lasted 6 months. The primary endpoint was the Relative Dose Intensity (RDI). Secondary endpoints included adherence, toxicity, response and survival, quality of life, pts experience (PACIC Score), end-of-life support, and economic estimation of the use of healthcare resources. Results: From October 2016 to May 2019, 609 pts (median age: 62 years, 20-92; PS2: 11.8%) were included. 39% were receiving oral chemotherapy, and 61% other OAA. The RDI was significantly higher in the CAPRI arm (93.4% ±0.26 vs. 89.4% ±0.19, p = 0.04). The CAPRI intervention also improved PACIC scores (mean: 2.94±0.83 vs. 2.67±0.89, p = 0.01), the number of unplanned hospitalizations (15.1% vs. 22.0%, p = 0.04), hospitalization duration (mean: 2.82±6.96 days vs. 4.44±9.60, p = 0.02), and treatment-related grade≥3 toxicities (27.6% vs. 36.9%, p = 0.02). Conclusions: Compared to SOC, the CAPRI intervention improved RDI, pts experience, hospitalizations and their duration, as well as the rate of treatment-related grade≥3 toxicities. This type of intervention should represent a new standard in pts receiving OAA. Clinical trial information: NCT02828462.