Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2026-01-09 @ 11:41 PM
Study NCT ID:
NCT03263416
Status:
COMPLETED
Last Update Posted:
2022-01-31
First Post:
2017-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating Treatment Adherence in Patients Treated With Oral Targeted Therapy in Oncology Supported by a Dedicated and Coordinated Follow-up Compared to Standard Follow-up.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 186}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-28', 'studyFirstSubmitDate': '2017-08-04', 'studyFirstSubmitQcDate': '2017-08-23', 'lastUpdatePostDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy: rate of patients who adhere to oral targeted therapy treatment administration.', 'timeFrame': '6 months per patient', 'description': 'This outcome will be assessed by the counting of tablets and the completion of the GIRERD questionnaire by the patient (assessment performed at 1, 3 and 6 months during the treatment)'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the number of drug adaptations proposed by the Center Pharmacist following the pharmaceutical conciliation', 'timeFrame': '6 months per patient'}, {'measure': 'Quality of life using the QLQ-C30 questionnaire', 'timeFrame': '6 months per patient'}, {'measure': 'Safety according to the classification of the Common for Toxicity Criteria for Adverse Events (CTCAE) V4.03', 'timeFrame': '6 months per patient'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metastatic solid tumor', 'Oral Targeted Therapy', 'Treatment adherence'], 'conditions': ['Metastatic Solid Tumor']}, 'descriptionModule': {'briefSummary': 'This is a prospective, comparative, open label, randomized, multicentric study evaluating the benefit of a dedicated and coordinated follow-up on treatment adherence in patients with metastatic solid tumor and starting a first cycle of treatment compared to standard follow-up. A dedicated and coordinated follow-up during the treatment period will be based on a telephone follow-up and a pharmaceutical conciliation.\n\nPatients will be randomized into one of two study arms:\n\nArm A (Experimental follow-up): coordinated follow-up performed by a dedicated nurse and a pharmaceutical conciliation made by the Center Pharmacist.\n\nArm B: Standard follow-up during the treatment period.\n\nPatients will be followed during 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient with a metastatic solid tumor and starting a first cycle of oral targeted therapy whatever the treatment line\n2. Age \\> or = 18 years old\n3. Affiliated to the french social security system\n4. Patient must provide written informed consent prior to any study-specific procedure or assessment\n\nExclusion Criteria:\n\n1. Patient not available by phone or with no caregiver who can answer the phone for him\n2. Pregnant or breastfeeding women\n3. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure\n4. Patient protected by law'}, 'identificationModule': {'nctId': 'NCT03263416', 'acronym': 'ADHESIPH', 'briefTitle': 'Study Evaluating Treatment Adherence in Patients Treated With Oral Targeted Therapy in Oncology Supported by a Dedicated and Coordinated Follow-up Compared to Standard Follow-up.', 'organization': {'class': 'OTHER', 'fullName': 'Institut Claudius Regaud'}, 'officialTitle': 'Regional, Multicentric, Randomized Study Evaluating Treatment Adherence in Patients Treated With Oral Targeted Therapy in Oncology Supported by a Dedicated and Coordinated Follow-up (Using a Telephone Follow-up by a Nurse and a Pharmaceutical Conciliation) Compared to Standard Follow-up.', 'orgStudyIdInfo': {'id': '17GENE02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'interventionNames': ['Other: Dedicated and coordinated follow-up']}, {'type': 'OTHER', 'label': 'Arm B', 'description': 'Standard', 'interventionNames': ['Other: Standard follow-up']}], 'interventions': [{'name': 'Dedicated and coordinated follow-up', 'type': 'OTHER', 'description': '* Coordinated follow-up performed by a dedicated nurse with consultations (before treatment initiation and during treatment) and a telephone follow-up during treatment period\n* Pharmaceutical conciliation before treatment initiation made by the Center Pharmacist\n* Completion of QLQ-C30 and GIRERD questionnaires', 'armGroupLabels': ['Arm A']}, {'name': 'Standard follow-up', 'type': 'OTHER', 'description': '\\- Completion of QLQ-C30 and GIRERD questionnaires', 'armGroupLabels': ['Arm B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81000', 'city': 'Albi', 'country': 'France', 'facility': 'Clinique Claude Bernard', 'geoPoint': {'lat': 43.9298, 'lon': 2.148}}, {'zip': '81108', 'city': 'Castres', 'country': 'France', 'facility': 'Centre Hospitalier Intercommunal Castres Mazamet', 'geoPoint': {'lat': 43.60527, 'lon': 2.24088}}, {'city': 'Cornebarrieu', 'country': 'France', 'facility': 'Clinique Des Cedres', 'geoPoint': {'lat': 43.64967, 'lon': 1.32588}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Institut Claudius Regaud', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Christine CHEVREAU, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Universitaire du Cancer Toulouse Oncopole'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Claudius Regaud', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}