In a single-centre, randomised phase III CAPRI study that compared an intervention combining nurse navigator-led follow-up and a smartphone application on top of usual care versus usual care in patients with advanced cancers treated with oral anticancer drugs met its primary endpoint of significant improvement in relative dose intensity (RDI), defined as the ratio of the dose actually delivered over time to the prescribed dose intensity. The CAPRI study showed a positive effect on patient experience of care, decrease of grade ≥3 toxicities, and cost control in terms of days of hospitalisation. The findings are published by Dr. Olivier Mir of the Department of Ambulatory Cancer Care, and Division of Interdisciplinary Patients Care Pathways, Gustave Roussy in Villejuif, France and colleagues on 25 April 2022 in the Nature Medicine.
The authors wrote in the background that remote patient monitoring has long been integrated into the management of chronic conditions with the aim to improve quality of care, to reduce costs and supplement or replace in-hospital care, and to offer convenience and closer management of clinical events. In the field of oncology, retrospective studies have suggested that remote patient monitoring could help in the monitoring of chemotherapy-related adverse events and could improve adherence to oral anticancer drugs. These retrospective studies involved nurse-led follow-up and the use of basic remote monitoring technologies, mostly phone calls and emails. However, a lack of rigorous methodology in such studies has limited the potential impact of these combined strategies.
Oral anticancer drugs represent 17% of approved drugs by US Food and Drug Administration from 2016 to 2020. In contrast with patients receiving intravenous chemotherapies, patients receiving oral anticancer drugs are usually monitored during consultations scheduled less frequently for prescription renewal and dose modifications. In the setting of oral anticancer therapy, the clinical challenges encompass not only the remote management of frequent drug-related or disease-related events and the need to incorporate nurse-led follow-up for optimal care, but also adherence issues, an underestimated cause of toxicity, decreased treatment efficacy and increased costs.
The aim of the CAPRI study was to evaluate an intervention combining a nurse navigator-led follow-up and a mobile application for patients receiving oral anticancer drugs on top of usual care, designed to pursue simultaneously improvement of the patient experience of care, improvement of the health of the target population, and reduction in the per capita cost of healthcare.
The primary endpoint was the RDI. Secondary endpoints included adherence, toxicity, response and survival, quality of life, patient experience and economic estimation of the use of healthcare resources. A longitudinal analysis of the intervention was also pre-planned to study adoption issues by patients and healthcare professionals.
Patients receiving approved oral anticancer drugs were randomised 1:1 to an intervention combining a nurse navigator-led follow-up system and a web portal–smartphone application on top of usual care, or to usual symptom monitoring at the discretion of the treating oncologist, for a duration of 6 months.
In 559 evaluable patients, the RDI was higher in the experimental arm (93.4% versus 89.4%, p = 0.04). The intervention improved the patient experience in terms of the Patient Assessment of Chronic Illness Care score (2.94 versus 2.67, p = 0.01), reduced the days of hospitalisation (2.82 versus 4.44 days, p = 0.02), and decreased treatment-related grade ≥3 toxicities (27.6% versus 36.9%, p = 0.02).
The authors commented that the nurse navigator positions were funded by the study budget; however, recent changes in the French healthcare financial laws now allow for the reimbursement of remote monitoring of patients with cancer as other care activities performed in hospitals, making this approach sustainable.
The authors also commented that future directions for the CAPRI programme are possible upgrades of the digital tool, a better identification of the patient subpopulations who derive the most benefit from this programme, and implementation of the programme in specific therapeutic areas. For example, neuro-oncology patients, in whom disease-related cognitive disorders might impair the optimal use of first-line oral treatments (e.g. temozolomide), represent candidates for this approach, and the CAPRI remote monitoring programme has already become a standard of care for neuro-oncology patients at their institution. Future research will also need to address the issue of psychological or emotional secondary outcomes. Furthermore, the development of electronic onco-geriatric evaluations and dedicated programmes for patients included in clinical studies represent fields of application with potentially rapid implementation and possible implementation of electronic patient-reported outcomes.
The authors have also reported the implementation of the CAPRI programme to monitor COVID-19 in patients with cancer, suggesting that nurse navigator-led digital interventions deserve further prospective assessment in other non-oncological conditions.
The study was funded by the French National Research Agency (ANR), the Agence Régionale de Santé (ARS) Ile-de-France, Philanthropia Lombard Odier Foundation, Novartis and AstraZeneca.
Mir O, Ferrua M, Fourcade A, et al. Digital remote monitoring plus usual care versus usual care in patients treated with oral anticancer agents: the randomized phase 3 CAPRI trial. Nature Medicine; Published online 25 April 2022. DOI: https://doi.org/10.1038/s41591-022-01788-1