Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-03-06 @ 12:52 AM
Study NCT ID:
NCT04172818
Status:
COMPLETED
Last Update Posted:
2023-03-22
First Post:
2019-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of a Diary for Allogenic Hematopoietic Stem Cell Transplantation Patients and Families
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-21', 'studyFirstSubmitDate': '2019-11-14', 'studyFirstSubmitQcDate': '2019-11-19', 'lastUpdatePostDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure of diary impact on patient quality of life', 'timeFrame': 'at day 0', 'description': 'the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.'}, {'measure': 'Measure of diary impact on patient quality of life', 'timeFrame': 'through the end of hospitalisation, an average of 3 weeks', 'description': 'the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.'}, {'measure': 'Measure of diary impact on patient quality of life', 'timeFrame': 'at 30 days after transplantation', 'description': 'the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.'}, {'measure': 'Measure of diary impact on patient quality of life', 'timeFrame': 'at day 100 after transplantation', 'description': 'the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.'}, {'measure': 'Measure of diary impact on patient quality of life', 'timeFrame': '6 months after transplantation', 'description': 'the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.'}, {'measure': 'Measure of diary impact on patient quality of life', 'timeFrame': 'a year after transplantation', 'description': 'the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.'}], 'secondaryOutcomes': [{'measure': 'Measure of diary impact on health care team satisfaction', 'timeFrame': 'at day 0', 'description': 'the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.'}, {'measure': 'Measure of diary impact on health care team satisfaction', 'timeFrame': 'through the end of hospitalisation, an average of 3 weeks', 'description': 'the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.'}, {'measure': 'Measure of diary impact on health care team satisfaction', 'timeFrame': 'at 30 days after transplantation', 'description': 'the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.'}, {'measure': 'Measure of diary impact on health care team satisfaction', 'timeFrame': 'at day 100 after transplantation', 'description': 'the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.'}, {'measure': 'Measure of diary impact on health care team satisfaction', 'timeFrame': '6 months after transplantation', 'description': 'the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.'}, {'measure': 'Measure of diary impact on health care team satisfaction', 'timeFrame': 'a year after transplantation', 'description': 'the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.'}, {'measure': 'Measure of diary impact on patient relative quality of life', 'timeFrame': 'at day 0', 'description': 'the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.'}, {'measure': 'Measure of diary impact on patient relative quality of life', 'timeFrame': 'through the end of hospitalisation, an average of 3 weeks', 'description': 'the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.'}, {'measure': 'Measure of diary impact on patient relative quality of life', 'timeFrame': 'at 30 days after transplantation', 'description': 'the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.'}, {'measure': 'Measure of diary impact on patient relative quality of life', 'timeFrame': 'at day 100 after transplantation', 'description': 'the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.'}, {'measure': 'Measure of diary impact on patient relative quality of life', 'timeFrame': '6 months after transplantation', 'description': 'the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.'}, {'measure': 'Measure of diary impact on patient relative quality of life', 'timeFrame': 'a year after transplantation', 'description': 'the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['allogenic hematopoietic stem cell transplantation', 'diary', 'psychological disorders'], 'conditions': ['Hematopoietic/Lymphoid Cancer', 'Psychological Disorder']}, 'descriptionModule': {'briefSummary': 'Allogenic hematopoietic stem cell transplantation is a specific time during hematological disease management for the patients, theirs relatives and the healthcare team. This heavy treatment is most of the time the last possible curative therapy and could cause many side effects such as infectious diseases and graft versus host reaction. The protective isolation is also a source of physical and psychological isolation. Published studies reported depressive syndrome, anxiety symptoms and post-traumatic stress disorders for patients and their families. Since 10 years ago, diaries are used in intensive care unit to limit these symptoms after a coma. In analogy, the diary for the patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long terms consequences. The investigators want to evaluate the psychological impact of a diary on the patients hospitalized for allogenic hematopoetic stem cell transplantation and on their relatives.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient age \\> 18 years\n* patient hospitalized for an hematopoietic allogenic stem cell transplantation\n* patient agreeing to participate\n\nExclusion Criteria:\n\n* patient not hospitalized for an hematopoietic allogenic stem cell transplantation'}, 'identificationModule': {'nctId': 'NCT04172818', 'acronym': 'JACintHE', 'briefTitle': 'Feasibility Study of a Diary for Allogenic Hematopoietic Stem Cell Transplantation Patients and Families', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Feasibility Study of a Diary for Allogenic Hematopoietic Stem Cell Transplantation Patients and Families', 'orgStudyIdInfo': {'id': 'PI2019_843_0005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with diary', 'description': 'Evaluation the psychological impact of a diary on the patients hospitalized for allogenic hematopoetic stem cell transplantation and on their relatives.', 'interventionNames': ['Behavioral: quality of life questionnaire']}], 'interventions': [{'name': 'quality of life questionnaire', 'type': 'BEHAVIORAL', 'description': 'Since 10 years ago, diaries are used in intensive care unit to limit these symptoms after a coma.In analogy, the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences. The psychological impact of a diary on patients hospitalized for allogenic hematopoetic stem cell transplantation and on their relatives will be evaluated.', 'armGroupLabels': ['Patients with diary']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'overallOfficials': [{'name': 'Delphine Lebon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Amiens'}, {'name': 'Marie Beaumont, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Amiens'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}