Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-03-06 @ 1:14 PM
Study NCT ID:
NCT03359759
Status:
COMPLETED
Last Update Posted:
2025-12-10
First Post:
2017-11-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Efficiency in Cancerology of New Technologies as Telemedicine and Conected Objects (e-DomSanté)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 's.mathoulin@bordeaux.unicancer.fr', 'phone': '+33556333333', 'title': 'Simone Mathoulin-Pélissier, Director of Clinical Trials', 'organization': 'Institut Bergonié'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '12 months. Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed', 'description': 'Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed', 'eventGroups': [{'id': 'EG000', 'title': 'Patients With Advanced Disease', 'description': 'Patients treated for an advanced metastasis breast cancer', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 3, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Quality of Life of the Patients at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Advanced Disease', 'description': 'Patients treated for an advanced metastasis breast cancer'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000', 'lowerLimit': '32', 'upperLimit': '84'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 months', 'description': 'QoL assessed using the score of the FACT-B questionnaire. The FACT-B (Functional Assessment of Cancer Therapy - Breast) is a quality of life questionnaire used primarily with breast cancer patients. It is a validated tool used in both clinical and research settings.\n\nTotal score range: 0-148 A higher score indicates better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients alive, not lost to follow-up, and with a completed questionnaire'}, {'type': 'PRIMARY', 'title': 'Quality of Life of the Patients at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Advanced Disease', 'description': 'Patients treated for an advanced metastasis breast cancer'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000', 'lowerLimit': '33', 'upperLimit': '77'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'QoL assessed using the score of the FACT-B questionnaire. The FACT-B (Functional Assessment of Cancer Therapy - Breast) is a quality of life questionnaire used primarily with breast cancer patients. It is a validated tool used in both clinical and research settings.\n\nTotal score range: 0-148 A higher score indicates better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients alive, not lost to follow-up, and with a completed questionnaire'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients With Advanced Disease', 'description': 'Patients treated for an advanced metastasis breast cancer'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients With Advanced Disease', 'description': 'Patients treated for an advanced metastasis breast cancer'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000', 'lowerLimit': '36', 'upperLimit': '82'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2017-11-27', 'resultsFirstSubmitDate': '2025-10-02', 'studyFirstSubmitQcDate': '2017-11-30', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-24', 'studyFirstPostDateStruct': {'date': '2017-12-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life of the Patients at 12 Months', 'timeFrame': '12 months', 'description': 'QoL assessed using the score of the FACT-B questionnaire. The FACT-B (Functional Assessment of Cancer Therapy - Breast) is a quality of life questionnaire used primarily with breast cancer patients. It is a validated tool used in both clinical and research settings.\n\nTotal score range: 0-148 A higher score indicates better quality of life.'}, {'measure': 'Quality of Life of the Patients at 6 Months', 'timeFrame': '6 months', 'description': 'QoL assessed using the score of the FACT-B questionnaire. The FACT-B (Functional Assessment of Cancer Therapy - Breast) is a quality of life questionnaire used primarily with breast cancer patients. It is a validated tool used in both clinical and research settings.\n\nTotal score range: 0-148 A higher score indicates better quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Telemedicine', 'Connected watches', 'Patient-Reported symptom monitoring', 'Secure Platform'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Observational study about patients treated for a metastasis breast cancer who live far from their comprehensive cancer center and followed by telemedicine, connected watches and patient-reported symptom monitoring.', 'detailedDescription': "The effectiveness of remote follow-up of cancer patients through weekly medicalquestionnaires filled in on their smartphone has been reported in international studies. Thesestudies demonstrated an improvement in quality of life (QoL) and survival of several months. Thee-DomSanté study proposes the combined use of innovative technological tools for theimprovement of patient care\n\nThis study was carried out with patients followed-up for metastatic breast cancer who lived far from their treatment center. They were offered, in addition to their usual follow-up, weekly medical questionnaires on an interactive tablet and aconnected watch that registered their falls, bedtime and their general activity. All this data arrive on a secure portal. In the event of an alert, telemedicine is organized by remote consultation with exchange on a secure platform, in parallel, between the center's carers and the treating physician, nurse, pharmacist or the Territorial Support Unit. The evaluation criteria used include telemedicine and patients' quality of life questionnaires as well as their satisfaction with care."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated for an advanced metastasis breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women more than 18 years old\n* Treated for an advanced metastasis breast cancer\n* Who live far from their comprehensive cancer center in the Landes department\n\nExclusion Criteria:\n\n* Women who are not able to understand the study because of psychiatric disease'}, 'identificationModule': {'nctId': 'NCT03359759', 'acronym': 'e-DomSanté', 'briefTitle': 'Evaluation of Efficiency in Cancerology of New Technologies as Telemedicine and Conected Objects (e-DomSanté)', 'organization': {'class': 'OTHER', 'fullName': 'Institut Bergonié'}, 'officialTitle': 'Evaluation of Efficiency in Cancerology of New Technologies as Telemedicine and Conected Objects (e-DomSanté)', 'orgStudyIdInfo': {'id': 'IB2016-eDOMSANTE'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Conected objects', 'type': 'OTHER', 'description': 'Every week, each patient report her symptoms and answer ten questions on the i-PAD. The connected watch reports the performance status (activtiy and time spent in bed or sitting), and the falls.\n\nIf nurses or doctors detect any problem, they ask the patient for a telemedicine to try to help her. During the same time, nurses or doctors send a message on a secure plateform to the local team (nurse, General Practitioner, and pharmacists) and they reserve a place for an hospitalization if necessary.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonie', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'overallOfficials': [{'name': 'Nathalie QUENEL-TUEUX, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Bergonié'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Bergonié', 'class': 'OTHER'}, 'collaborators': [{'name': 'Région Nouvelle Aquitaine', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}