Impacts of a navigation program based on health information technology for patients receiving oral anticancer therapy: the CAPRI randomized controlled trial

BACKGROUND: The emergence of oral delivery in cancer therapeutics is expected to result in an increased need for better coordination between all treatment stakeholders, mainly to ensure adequate treatment delivery to the patient. There is significant interest in the nurse navigation program’s potential to improve transitions of care by improving communication between treatment stakeholders and by providing personalized organizational assistance to patients. The use of health information technology is another strategy aimed at improving cancer care coordination that can be combined with the NN program to improve remote patient follow-up. However, the potential of these two strategies combined to improve oral treatment delivery is limited by a lack of rigorous evidence of actual impact. METHODS/DESIGN: We are conducting a large scale randomized controlled trial designed to assess the impact of a navigation program denoted CAPRI that is based on two Nurse Navigators and a web portal ensuring coordination between community and hospital as well as between patients and navigators, versus routine delivery of oral anticancer therapy. The primary research aim is to assess the impact of the program on treatment delivery for patients with metastatic cancer, as measured by Relative Dose Intensity. The trial involves a number of other outcomes, including tumor response, survival, toxic side effects, patient quality of life and patient experience An economic evaluation adopting a societal perspective will be conducted, in order to estimate those health. care resources’ used. A parallel process evaluation will be conducted to describe implementation of the intervention. DISCUSSION: If the CAPRI program does improve treatment delivery, the evidence on its economic impact will offer important knowledge for health decision-makers, helping develop new follow-up services for patients receiving oral chemotherapy and/or targeted therapy. The process evaluation will determine the best conditions in which such a program might be implemented. TRIAL REGISTRATION: NCT 02828462. Registered 29 June 2016.