Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT04856332
Status:
COMPLETED
Last Update Posted:
2025-02-28
First Post:
2021-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Evaluating the Parent-child Relationship During the Hospitalisation of a Parent in Long-term Protective Isolation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-06-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2021-04-08', 'studyFirstSubmitQcDate': '2021-04-19', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Evaluation of the use of a telepresence robot on the parent-child relationship in maintaining parenthood during parent's hospitalisation in long-term protective isolation", 'timeFrame': 'Through study completion, an average of 3 months', 'description': 'Observation of communications between the hospitalised patient and his/her chid(children) by a specialist in human and social sciences'}, {'measure': "Evaluation of the use of a telepresence robot on the parent-child relationship in maintaining parenthood during parent's hospitalisation in long-term protective isolation", 'timeFrame': 'Through study completion, an average of 3 months', 'description': 'Interview with the hospitalised patient (parent) by a specialist in human and social sciences'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the experience linked to the robot availability on the concerned persons (patient, children, person on charge of children)', 'timeFrame': 'Through study completion, an average of 3 months', 'description': 'Interview with the hospitalised patient (parent) and the person in charge of children by a specialist in human and social sciences'}, {'measure': "Evaluation of patient's satisfaction", 'timeFrame': 'Through study completion, an average of 3 months', 'description': 'Interview with the hospitalised patient (parent) and the person in charge of children by a specialist in human and social sciences'}, {'measure': "Evaluation of the impact of robot use on patient's coping strategies (adaptation and adjustment to illness and hospitalisation)", 'timeFrame': 'Through study completion, an average of 3 months', 'description': 'Interview with the hospitalised patient and the person in charge of children by a specialist in human and social sciences'}, {'measure': "Evaluation of patient's experience of hospitalisation", 'timeFrame': 'Through study completion, an average of 3 months', 'description': 'Interview with the hospitalised patient and the person in charge of children by a specialist in human and social sciences'}, {'measure': "Evaluation of the impact of the robot's presence at home on the children and the person in charge of the children during patient's hospitalisation", 'timeFrame': 'Through study completion, an average of 3 months', 'description': 'Interview with the hospitalised patient and the person in charge of children by a specialist in human and social sciences'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer', 'Long-term protective isolation', 'Patient-child relationship'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'The intensive treatments of certain cancers and haemopathies require the implementation of a protective isolation from external micro-organisms for a period of several weeks. This isolation implies a limitation of visitors and sometimes prohibits access to young children. This raises questions concerning the maintenance of family links, and in particular the parent-child relationship as well as the psychological and emotional isolation of hospitalised patients and the resulting psychological effects.', 'detailedDescription': "Telepresence robots are increasingly used as a means of remote communications, especially for teleconsultations and/or access to various public services (cultural events, education, etc.). In the context of long-term hospitalisation, they can be used for various purposes, such as access to cultural events, university activities, contact with patient's home and maintenance of family links. Some studies have analyzed the use of these robots and their effects in academic settings or the suitability of their use with elderly populations for continuing care.\n\nTo our knowledge, no study has evaluated the interest for the parent-child relationship of the use of a telepresence robot during the hospitalisation in protective isolation for a long period of a patient with young child(ren).\n\nWe propose to conduct this observational, multi-center prospective study aiming at evaluating the parent-child relationship following the setting up of a mobile telepresence robot for patients with children aged 15 years or less and hospitalised in long-term protective isolation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Observational prospective study, multicenter of parent-child relationship assessment following the setting up of a mobile telepresence robot for patients with children aged 15 years or less and hospitalised in long-term protective isolation. This study is based on semi-directed interviews and observations made during patient's hospitalisation and when patient returns at home.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ageā„ 18\n* Patient with at least one child aged 15 or under\n* Pathology requiring a prolonged hospitalization in protective isolation\n* Consent dated and signed\n\nExclusion Criteria:\n\n* Impaired cognitive functions\n* Performance Status -Eastern Cooperative Oncology Group (PS-ECOG) = 4\n* Difficulties in speaking and understanding French\n* Patient under guardianship or curatorship'}, 'identificationModule': {'nctId': 'NCT04856332', 'acronym': 'VIK-e2', 'briefTitle': 'Study Evaluating the Parent-child Relationship During the Hospitalisation of a Parent in Long-term Protective Isolation', 'organization': {'class': 'OTHER', 'fullName': 'Centre Leon Berard'}, 'officialTitle': 'VIK-e2 - Observational, Multicenter Prospective Study Evaluating Parent-child Relationship with the Setting Up of a Mobile Telepresence Robot for Patients with Children Aged 15 Years or Less and Hospitalised in Long-term Protective Isolation', 'orgStudyIdInfo': {'id': 'ET19-193 - VIK-e2'}}, 'armsInterventionsModule': {'interventions': [{'name': "Telepresence robot installed at child's home during parent's hospitalisation", 'type': 'OTHER', 'description': "Telepresence robot installed at child's home during parent's hospitalisation in long term protective isolation for maintaining parent-child ink (only children aged 15 years or less are concerned)"}]}, 'contactsLocationsModule': {'locations': [{'zip': '69008', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Leon Berard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Centre Hospitalier Lyon Sud', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13000', 'city': 'Marseille', 'country': 'France', 'facility': 'Institut Paoli Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'GUILLERMIN Yann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Leon Berard'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Leon Berard', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}