Study protocol of the CREDO randomised controlled trial: evaluation of a structured return home consultation for patients suffering from metastaticcancer.

ABSTRACT

INTRODUCTION: Patients suffering from cancer are often managed by multiple health professionals. General practitioners with specific skills in oncology could facilitate care coordination between hospital and general practice in the management of these patients. To explore this hypothesis, we run a randomised clinical trial, called 'Concertation de REtour à DOmicile, CREDO'. The main objective is to explore the effectiveness of a 'return home' consultation compared with standard care. The number of unscheduled visits to care centres is used to evaluate the effectiveness of the treatment. METHODS AND ANALYSIS: CREDO is a multicentre, randomised, open-label, prospective trial. It takes place in two specialised cancer care centres in southern France (Occitania region). Patient inclusion criteria are be over 18 years old; be treated with a first cycle of metastatic chemotherapy in a specialised cancer care centre; have a metastatic solid cancer and be returning home after treatment. Patients are randomised in two arms standard-arm (conventional management) or intervention-arm (CREDO management). In the intervention arm, a 'return home' consultation is carried out in three steps. First, the investigating GP (GP with specific skills in oncology) from the specialised care centre collects information about the patient and patient's management choices. Then, the investigating GP conducts an interview with the patient's referring GP to quickly communicate and discuss information about the patient. Finally, the investigating GP summarises these exchanges and transmits this information to the care centres chosen by the patient.All the patients are followed for 1 year.Statistical and medicoeconomic analysis are planned. ETHICS AND DISSEMINATION This clinical trial is registered under ClinicalTrials.gov identifier and was approved by the ethics committee of South-Western French Committee for the Protection of Persons (number 2016-A01587-44) and from the French National Drug Safety Agency (ANSM, number 2016111500034).An international publication of the final results and conference presentations will be planned. TRIAL REGISTRATION NUMBER NCT02857400.