The emergence of oral delivery in cancer therapeutics results in an increased need for better coordination between all treatment stakeholders, mainly to ensure adequate treatment delivery to the patient. There is a significant interest in cancer care coordination programs, especially those combining Nurse Navigators (NN) and the use of new technologies. However, the potential impact of these combined strategies is limited by a lack of rigorous evidence.
A monocentric randomized trial (1,000 patients, 1:1) is designed to assess the impact of a cancer care coordination program namely CAPRI. This program is based on two NN and a web application. NN ensure remote patient monitoring, via phone calls and email. They also provide a link between hospital professionals, patients and primary care professionals (GP, private nurse, pharmacist, etc.) by giving them access to the web application with the patient’s authorization. Patients can enter data related to their health. Alerts are sent to the NN in case of abnormal data. NN evaluate the alert level on the basis of algorithms and determine the necessary action. The study will evaluate CAPRI’s efficacy in comparison with regular care during a 6-month period for adult patients with metastatic cancer. Hypothesis is that with a closer monitoring of the patient, the management of toxicities is more efficient and results in fewer dose adjustments of oral cancer therapeutics and avoids unnecessary hospital visits. The primary research aim is to assess the impact of the CAPRI program on treatment delivery for cancer patients who started oral cancer therapy, as measured by Relative Dose Intensity. The trial involves several secondary outcomes: patient adherence, tumor response, survival, toxicities, patient quality of life and patient experience. An economic evaluation adopting a societal perspective will be conducted, in order to estimate the use of healthcare resources. A parallel process evaluation will be conducted to describe the implementation of the CAPRI program. Of the 1,000 patients to be recruited, 109 patients are currently enrolled since November 2016.
Clinical trial identification
Legal entity responsible for the study
National Research French Agency, Philanthropia Lombard Odier Foundation, Astrazeneca, Novartis
All authors have declared no conflicts of interest.