protocolSection identificationModule nctId: NCT06381024, orgStudyIdInfo id: 2022 A02702-41, briefTitle: A Study of Telemonitoring in Cancer Patients, acronym: MINERVA, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-04, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier de Bligny, class: OTHER, collaborators name: Exystat, collaborators name: Cureety, collaborators name: Pharmaspecific, collaborators name: ProPens, descriptionModule briefSummary: The goal of this prospective, randomized, unblinded, single-centre, interventional study is to assess the effectiveness of standard of care with Cureety, compared to standard of care alone, to reduce the number of all telephone calls during the first 4 months of oral or intravenous cancer treatment for patients older than 18 years of age, initiating oral or intravenous cancer treatment at the Centre Hospitalier de Bligny.Patients initiating either oral or intravenous chemotherapy for cancer will be randomly allocated in a 1:1 ratio to either:* In-person care alone (Standard of care group).* In-person care with Cureety telemonitoring (Standard of care with Cureety group).Participants will:* be monitored with digital application Cureety (Standard of care with Cureety group)* fill out quality of life questionnaire (baseline, 2 months, 4 months)* fill out satisfaction questionnaire (2 months, 4 months)* have the ongoing and incoming phone calls logged (duration and type), conditionsModule conditions: Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients initiating either oral or intravenous chemotherapy for cancer will be randomly allocated in a 1:1 ratio to either:* In-person care alone (Standard of care group).* In-person care with telemonitoring (Standard of care with Cureety group).The randomization will be stratified by:• Oral versus intravenous cancer treatment. The number of patients initiating oral treatment at randomization will be restricted to 20 patients., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 82, type: ESTIMATED, armsInterventionsModule interventions name: remote patient monitoring, outcomesModule primaryOutcomes measure: Number of all telephone calls during the first 4 months of oral or intravenous cancer treatment, secondaryOutcomes measure: Duration of all telephone calls during the first 4 months of oral or intravenous cancer treatment, secondaryOutcomes measure: Numbers of telephone calls during the first 4 months of cancer treatment in subgroups, secondaryOutcomes measure: Hospital-free survival rate, secondaryOutcomes measure: Quality of life at 2 and 4 months after initiation of cancer treatment., secondaryOutcomes measure: Patient satisfaction with the healthcare provided, secondaryOutcomes measure: CH Bligny staff satisfaction with the healthcare provided, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Hospitalier de Bligny, status: RECRUITING, city: Briis-sous-Forges, zip: 91640, country: France, contacts name: Ingrid Alexandre, MD, role: CONTACT, phone: +33169263138, email: i.alexandre@chbligny.fr, contacts name: Ingrid Alexandre, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.62399, lon: 2.12112, hasResults: False