protocolSection identificationModule nctId: NCT06371911, orgStudyIdInfo id: 2023-A02762-43, briefTitle: Benefit of Adding Cureety TechCare Telemonitoring to Usual Care During Injectable Anticancer Treatment, acronym: OPTIMACURE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2024-08-03, completionDateStruct date: 2024-12-03, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Centre Francois Baclesse, class: OTHER, collaborators name: Cureety, descriptionModule briefSummary: Currently, during usual care, it is critical to assess whether a patient is apt to receive injectable anticancer treatment in the days prior to the administration. To assess this, blood tests are usually performed in the days leading up to the planned administration. A hospital staff member then telephones the patients and evaluates, using the tests results and other patient data (including the presence of adverse events (AEs) and Eastern Cooperative Oncology Group \[ECOG\] performance status), whether the patient is apt for treatment or whether the treatment needs to be deferred.In France, the Centre François Baclesse in Caen (France) launched the OPTIMA program to optimize the prescription and preparation of chemotherapy in the ambulatory unit of the hospital.A prospective study validating the OPTIMA program found that the prescription of chemotherapy was accurate with significantly reduced waiting times for patients between the planned appointment time and initiation of chemotherapyThe OPTIMA program is now part of usual care at the Centre François Baclesse.Following the positive impact of both the OPTIMA and "Star" programs, several French healthcare centers have implemented similar programs. However, a large proportion of the data during the program are collected by telephone, particularly outgoing calls (from the hospital staff to patients). Thus, implementing these programs is expected to increase the number and/or duration of outgoing calls and consequently the workload of hospital staff.Since the deployment of the OPTIMA program (between 2014 and 2016), and other equivalent programs, more and more patients have asked for the telephone calls to be replaced by a web-based application. Indeed, patients do not always respond to the telephone calls made by hospital staff, thus forcing staff to repeat calls several times. Also, some patients with language or hearing difficulties are unable to answer the questionnaires by telephone: a web-based alternative would be more appropriate for these patients.Telemonitoring can collect blood test results and other patient data required to evaluate whether patients are apt for injectable cancer treatment. Telemonitoring can then identify the few patients that need to be contacted by hospital staff, thus reducing the number of outgoing telephone calls.There is growing evidence of the benefits of adding telemonitoring to usual care for patients undergoing cancer treatment. The benefits include the early detection of AEs, improved quality of life (QoL), fewer admissions to emergency rooms or hospitalization, the longer remaining on chemotherapy for patients, and extended overall survival.Cureety is a digital telemonitoring platform, specifically designed to monitor signs and symptoms of disease progression and AEs in cancer patients. The digital tool includes questionnaires for each class of medication to monitor patients' adverse events remotely. The data collected include blood results, treatment-related data (including delays, dose reductions), as well as QoL and safety data. In terms of safety, patients respond to an electronic patient-reported outcome (ePRO) questionnaire based on the NCI-CTCAE version (v)5.0. Depending on the responses, the Cureety TechCare algorithm classifies the patient state as "correct", "compromised", "to be monitored", or "critical". The patients are then notified of the actions to be taken according to their classification. In preparation for injectable cancer treatment, Cureety can collect the data necessary to evaluate whether patients are apt for treatment administration. The collection and evaluation of this data is expected to decrease outgoing calls by between 30% to 50%.This study was designed to evaluate whether adding Cureety telemonitoring to usual care would reduce the number of outgoing calls for hospital staff during the management of patients undergoing injectable at one of the participating centers compared with the usual care including a program for anticipation of injectable treatment (OPTIMA program or equivalent)., conditionsModule conditions: Adult Patients Initiating Injectable Anticancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 192, type: ESTIMATED, armsInterventionsModule interventions name: Cureety telemonitoring, interventions name: OPTIMA or equivalent programs, outcomesModule primaryOutcomes measure: Effectiveness of adding Cureety telemonitoring to usual care, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre hospitalier de Bligny, status: NOT_YET_RECRUITING, city: Bligny, country: France, contacts name: Jean-Baptiste MERRIC, MD, role: CONTACT, email: jb.meric@chbligny.fr, contacts name: Jean-Baptiste MERRIC, MD, role: PRINCIPAL_INVESTIGATOR, locations facility: Centre François Baclesse, status: RECRUITING, city: Caen, zip: 14000, country: France, contacts name: Audrey Faveyrial, MD, role: CONTACT, email: a.faveyrial@baclesse.unicancer.fr, contacts name: Jean-Michel Grellard, role: CONTACT, email: jm.grellard@baclesse.unicancer.fr, contacts name: Audrey Faveyrial, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.18585, lon: -0.35912, locations facility: Centre de Radiothérapie et Oncologie Médicale d'Osny, status: NOT_YET_RECRUITING, city: Osny, country: France, contacts name: Abderrezak LADOUANI, MD, role: CONTACT, email: a.ladouani@crom95.com, contacts name: Abderrezak LADOUANI, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.0701, lon: 2.06277, hasResults: False