Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 12:02 AM
Study NCT ID:
NCT03472794
Status:
COMPLETED
Last Update Posted:
2019-09-04
First Post:
2018-01-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adaptation of a Knowledges Exchange Portal Between (KEP) Healers and Patients : Obstacles and Sources to KEP Use for Breast Cancer Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-03', 'studyFirstSubmitDate': '2018-01-31', 'studyFirstSubmitQcDate': '2018-03-13', 'lastUpdatePostDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasability of the web portal', 'timeFrame': 'Month 6', 'description': 'Number of connections to the portal each month:\n\n* Types of documents consulted\n* Types of downloaded documents\n* Types of documents sought\n* Connection duration\n* Number of connections\n* Number of comments / questions posted\n* Number of comments / questions viewed\n* Number of comments / questions sought'}], 'secondaryOutcomes': [{'measure': 'Number of the portal connections realized each month', 'timeFrame': 'Month 6', 'description': 'Number of the portal connections realized each month'}, {'measure': 'Number of webpages used', 'timeFrame': 'Month 6', 'description': 'Number of webpages used'}, {'measure': 'Number of status posted', 'timeFrame': 'Month 6', 'description': 'Number of status posted'}, {'measure': 'Number of comments/questions posted', 'timeFrame': 'Month 6', 'description': 'Number of comments/questions posted'}, {'measure': 'Number of "like" emoticon posted', 'timeFrame': 'Month 6', 'description': 'Number of "like" emoticon posted'}, {'measure': 'Number of "comfort" emoticon posted', 'timeFrame': 'Month 6', 'description': 'Number of "comfort" emoticon posted'}, {'measure': 'Number of "favorites" emoticon posted', 'timeFrame': 'Month 6', 'description': 'Number of "favorites" emoticon posted'}, {'measure': 'Number of "mood" posted', 'timeFrame': 'Month 6', 'description': 'Number of "mood" posted'}, {'measure': 'Number of private posts posted', 'timeFrame': 'Month 6', 'description': 'Number of private posts posted'}, {'measure': 'Number of webpages consulted', 'timeFrame': 'Month 6', 'description': 'Number of webpages consulted'}, {'measure': 'Number of leaflets consulted', 'timeFrame': 'Month 6', 'description': 'Number of leaflets consulted'}, {'measure': 'Headings of leaflets consulted', 'timeFrame': 'Month 6', 'description': 'Headings of leaflets consulted'}, {'measure': 'Number of cards consulted', 'timeFrame': 'Month 6', 'description': 'Number of cards consulted'}, {'measure': 'Headings of cards consulted', 'timeFrame': 'Month 6', 'description': 'Headings of cards consulted'}, {'measure': 'Number of videos consulted', 'timeFrame': 'Month 6', 'description': 'Number of videos consulted'}, {'measure': 'Headings of videos consulted', 'timeFrame': 'Month 6', 'description': 'Headings of videos consulted'}, {'measure': 'Number of address consulted in the address list', 'timeFrame': 'Month 6', 'description': 'Number of address consulted in the address list'}, {'measure': 'Number of upcoming events consulted', 'timeFrame': 'Month 6', 'description': 'Number of upcoming events consulted'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The project is imbued with the whole problematic of patient follow-up and patient support, taking into account the experiences and needs of breast cancer patients. It concerns the dissemination of knowledge through the implementation of a specific clinical innovation designed to optimizing breast cancer patient pathway. The " Patients en réseau " association offers us to participate at the web platform evolution Mon Réseau Cancer du Sein in adapting it. The feasibility study focuses on (1) the platform utilization and (2) sources and obstacles to its utilization in the French context', 'detailedDescription': 'One of the French Cancer Plan 2014-2019 objectives is to improve the town-hospital coordination and information\'s exchange between professionals. This research project aims to reach this important objective of exchange development and the amelioration of the coordination concerning breast cancer women. Breast cancer requires the integration of aggressive treatments implying physical, psychological and social consequences. That\'s why an optimized care pathway needs a coordinated and multidisciplinary organization, and more particularly a personalized approach taking into account the whole patients\' needs in physical, psychological and social perspectives. To reach this goal, it is important to support those patients, to answer their needs for a better disease management in their own health pathways. The research issues lie in this outcome.\n\nThe project is imbued with the whole problematic of patient follow-up and patient support, taking into account the experiences and needs of breast cancer patients. It concerns the dissemination of knowledge through the implementation of a specific clinical innovation designed to optimizing breast cancer patient pathway.\n\nThe " Patients en réseau " association offers us to participate at the web platform evolution Mon Réseau Cancer du Sein in adapting it. The feasibility study focuses on (1) the platform utilization and (2) sources and obstacles to its utilization in the French context'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '30 women with a breast cancer will participate to the study, they will represent a sufficient and realis effective considering the active list of treated patients with a breast cancer at the Bergonié Institute.\n\n5 healers (one nurse, two doctors, a senior health manager, a manipulator in medical imaging)', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria of patients :\n\n* Age ≥ 18 y.o;\n* With a diagnosis of breast cancer,\n* treated at the Bergonié Institute;\n* Patients who express a non-opposition to participate to SAVAQ research;\n* Patients who have an Internet access at home.\n\nInclusion criteria of healers :\n\n\\- Doctors, Nurse, Senior health manager, Technologist medical imaging from the center participated to the research\n\nExclusion criteria of patients:\n\n* Patients with a severe psychiatric pathology (medical diagnosis);\n* Patients who doesn't speak French"}, 'identificationModule': {'nctId': 'NCT03472794', 'acronym': 'Sav-AQ', 'briefTitle': 'Adaptation of a Knowledges Exchange Portal Between (KEP) Healers and Patients : Obstacles and Sources to KEP Use for Breast Cancer Women', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Adaptation of a Knowledges Exchange Portal (KEP) Between Healers and Patients : Study of Obstacles and Sources to the Use of a KEP in the Case of Women Affected by a Breast Cancer in Nouvelle Aquitaine(Sav-AQ)', 'orgStudyIdInfo': {'id': 'CHUBX 2016/19'}}, 'armsInterventionsModule': {'interventions': [{'name': 'web portal: " Mon réseau cancer du sein " ("My Breast cancer Network")', 'type': 'OTHER', 'description': 'web portal: " Mon réseau cancer du sein "'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonié', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'collaborators': [{'name': 'SRIOP 2016, SIRIC BRIO', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}