Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT04323605
Status:
UNKNOWN
Last Update Posted:
2020-12-03
First Post:
2020-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assistance Program for Outpatients Following an Allogeneic Hematopoietic Stem-cell Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], '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': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2022-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-02', 'studyFirstSubmitDate': '2020-03-24', 'studyFirstSubmitQcDate': '2020-03-24', 'lastUpdatePostDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of patients with all the navigation nurse intervention files received at 100%', 'timeFrame': '12 months', 'description': "Rate of patients with all the navigation nurse intervention files received at 100%.\n\nA file is received at 100% if the 4 following tasks are fully completed:\n\n1. \\- patient called by nurse (and response from the patient at the set telephone appointment)\n2. \\- completion of medical-psycho-social questionnaire (AMA-ALLO phone call form) by nurse with the patient's responses\n3. \\- information and transmission of questionnaire results by nurse to the transplant physician\n4. \\- physician/nurse decision for potential intervention (specialized consultation, consultation with the transplant physician, hospitalization, modification of treatments, additional exams to carry out, etc.)"}], 'secondaryOutcomes': [{'measure': 'Rate of refusal for participation in the study', 'timeFrame': '12 months', 'description': 'Rate of patients who refused participating in the study'}, {'measure': 'Rate of ineligibility of the navigation nurse intervention files', 'timeFrame': '12 months', 'description': 'Rate of ineligibility of the navigation nurse intervention files (a single incomplete task out of 4 per intervention file renders the file ineligible)'}, {'measure': 'Quality of life for transplant patients', 'timeFrame': 'Baseline', 'description': 'Quality of life for transplant patients is assessed with the Functional Assessment of Cancer Therapy--Leukemia (FACT-Leu) questionnaire version 4. Fo each question, the 5 modality answers are: 0=not all, 1= a little bit, 2=somewhat, 3=quite a bit, 4=very much'}, {'measure': 'Quality of life for transplant patients', 'timeFrame': '6 months', 'description': 'Quality of life for transplant patients is assessed with the Functional Assessment of Cancer Therapy--Leukemia (FACT-Leu) questionnaire version 4. Fo each question, the 5 modality answers are: 0=not all, 1= a little bit, 2=somewhat, 3=quite a bit, 4=very much'}, {'measure': 'Quality of life for transplant patients', 'timeFrame': '12 months', 'description': 'Quality of life for transplant patients is assessed with the Functional Assessment of Cancer Therapy--Leukemia (FACT-Leu) questionnaire version 4. Fo each question, the 5 modality answers are: 0=not all, 1= a little bit, 2=somewhat, 3=quite a bit, 4=very much'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['allogeneic hematopoietic stem-cell transplant', 'outpatient assistance', '"navigation" nurse'], 'conditions': ['Hematologic Neoplasms']}, 'descriptionModule': {'briefSummary': 'After the initial monitoring period during hospitalization and isolation, patients with recent transplants are regularly monitored in monthly consultations but are still fragile, immunosuppressed and undergoing many treatments. The implementation of an outpatient assistance program for transplant patients should be feasible and allow for the improvement in medical-psycho-social care for the patients during this fragile and risky period, improve the satisfaction and quality of life for these transplant patients and assist in their socio-professional and familial reintegration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients over 18 years of age\n* Having received an allogeneic hematopoietic stem-cell transplant\n* In full remission\n* Outpatients\n* Having given their informed consent for the participation in the outpatient assistance program with a navigation nurse (AMA-ALLO) at the first post-transplant consultation (starting on Day 100 +/- 10 days post-transplant i.e., when the patient passes the initial post-transplant monitoring period in hospitalization (conventional or by day) to the monitoring period in monthly medical consultations) and continuing for 12 months\n* Affiliated with the social security system\n\nExclusion Criteria:\n\n* Transplant patients not having given their informed consent for inclusion in AMA-ALLO\n* Hospitalized or non-outpatient transplant patients\n* Post-transplant patients in cytological relapse\n* Patients under a legal regime of adult protection (guardianship, curatorship, etc.)'}, 'identificationModule': {'nctId': 'NCT04323605', 'acronym': 'AMA-ALLO', 'briefTitle': 'Assistance Program for Outpatients Following an Allogeneic Hematopoietic Stem-cell Transplant', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Implementation of an Assistance Program for Outpatients Following an Allogeneic Hematopoietic Stem-cell Transplant: Pilot Feasibility Study', 'orgStudyIdInfo': {'id': 'RC31/16/8771'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'outpatient assistance program', 'interventionNames': ['Other: Outpatient assistance program for transplant patients (AMA-ALLO) based on a "navigation" nurse']}], 'interventions': [{'name': 'Outpatient assistance program for transplant patients (AMA-ALLO) based on a "navigation" nurse', 'type': 'OTHER', 'description': 'Integration of a post-transplant "navigation" nurse starting at the first post-transplant consultation (starting from D100 +/- 10 days post-transplant). Different times for post-transplant telephone monitoring (every week for the first 2 months, then every 15 days for the next 3 months then once a month for 7 months)', 'armGroupLabels': ['outpatient assistance program']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toulouse', 'country': 'France', 'contacts': [{'name': 'Anne Huynh, MD', 'role': 'CONTACT', 'email': 'Huynh.Anne@iuct-oncopole.fr'}, {'name': 'Anne Huynh, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Cécile Borel, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sarah Guenounou, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Toulouse University Hospital', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Anne HUYNH, MD', 'role': 'CONTACT', 'email': 'huynh.anne@iuct-oncopole.fr', 'phone': '33-531156354'}, {'name': 'Anne HUYNH', 'role': 'CONTACT', 'email': 'huynh.anne@iuct-oncopole.fr'}], 'overallOfficials': [{'name': 'Anne HUYNH, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University hospital of Toulouse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}