Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2026-04-13 @ 8:42 PM
Study NCT ID:
NCT03800095
Status:
UNKNOWN
Last Update Posted:
2021-03-24
First Post:
2018-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Palliative Care for Patients With Haematological Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'no masking'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-23', 'studyFirstSubmitDate': '2018-09-13', 'studyFirstSubmitQcDate': '2019-01-10', 'lastUpdatePostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life evaluation: standardized questionnaire', 'timeFrame': 'at 6 months', 'description': 'Evaluation of quality of life by a standardized questionnaire : Functional Assessment of Cancer Therapy-Anemia (FACT-An). The higher is the score the better is the quality of life. FACT-An is composed by five subscales: Physical Well-Being \\[score range 0-28\\], Social/Family Well-Being \\[score range 0-28\\], Emotional Well-Being \\[score range 0-24\\], and Functional Well-Being \\[score range 0-28\\] and specific questions concerning anemia \\[score range 0-80\\]. The score at each items is summed. The sum is multiplied par the number of items in the subscale and then divided by the number of items answered. This produces the subscale score. The subscale scores are added to derive total score \\[score range 0-188\\].'}], 'secondaryOutcomes': [{'measure': 'Presence of discomfort symptoms', 'timeFrame': 'at Day 0, 3 months, 6 months, 9 months, 12 months', 'description': 'evaluated by Edmonton scale (depressive syndrome measured by the geriatric depression scale GDS)'}, {'measure': 'overall survival', 'timeFrame': 'at day 1 : from the randomization until the date of death or until 1 year [study end].'}, {'measure': 'Satisfaction of the care pathwaydesired by the patient', 'timeFrame': 'at 12 months or death', 'description': 'matching between patients desires writing in the medical file and the providing care'}, {'measure': 'cost-effectiveness analysis', 'timeFrame': 'at 12 months or death', 'description': 'The cost criteria selected will be all the direct medical costs inherent in care in both arms (costs of hospitalizations, consultations, treatments, medical devices).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Supportive care', 'Early palliative care', 'Quality of life', 'Symptoms management', 'Haematological malignancy'], 'conditions': ['Acute Myeloid Leukemia', 'Myelodysplastic Syndrome', 'Diffuse Large B Cell Lymphoma', 'Palliative Care']}, 'descriptionModule': {'briefSummary': "Patients suffering from haematological disease present symptoms of discomfort and currently benefit from palliative care skills only for the management of their end-of-life. However, in medical oncology, more and more studies tend to demonstrate the benefit on the quality of life of an early collaboration between the two specialties.\n\nInvestigator did the hypothesis that early integration of palliative care with conventional haematological care could decrease discomfort symptoms and add a real benefit on the patients' quality of life .", 'detailedDescription': "Patients suffering from haematological disease present symptoms of discomfort and currently benefit from palliative care skills only for the management of their end-of-life. However, in medical oncology, more and more studies tend to demonstrate the benefit on the quality of life of an early collaboration between the two specialties.\n\nInvestigator did the hypothesis that early integration of palliative care with conventional haematological care could decrease discomfort symptoms and add a real benefit on the patients' quality of life ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients are over 70 years old\n* Patients from being diagnosed with acute myeloid leukemia and high-risk myelodysplastic syndrome or after the third line of therapy for high-grade lymphoma.\n\nExclusion Criteria:\n\n* All patients with a curative project (induction chemotherapy ou allogenic transplantation)\n* All patients in a terminal palliative status\n* Patients who don't speak French,\n* Patients not able to read and write\n* Patients who don't agree to participate in the protocol\n* Patients with psychiatric troubles or cognitive disorders\n* Patients under guardianship or curatorship, deprived of freedom or under justice protection."}, 'identificationModule': {'nctId': 'NCT03800095', 'acronym': 'CALVI', 'briefTitle': 'Early Palliative Care for Patients With Haematological Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Early Palliative Care for Patients With Haematological Malignancies: A Randomised Prospective Study', 'orgStudyIdInfo': {'id': 'CHU-406'}, 'secondaryIdInfos': [{'id': '2017-A02515-48', 'type': 'OTHER', 'domain': '2017-A02515-48'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conventional haematological care', 'description': 'Patients with haematological malignancy Conventional haematological care', 'interventionNames': ['Drug: Early palliative care integration']}, {'type': 'EXPERIMENTAL', 'label': 'Conventional care associated with a monthly consultation', 'description': 'Patients with haematological malignancy Conventional care associated with a monthly consultation realized by a palliative and supportive care team', 'interventionNames': ['Drug: Early palliative care integration']}], 'interventions': [{'name': 'Early palliative care integration', 'type': 'DRUG', 'description': 'The follow-up time for each patient is 12 months with evaluation of the main objective by a standardized questionnaire: The Functional Assessment of Cancer Therapy-Anaemia (FACT-An) Scale at 6 months. Throughout the study, patients included will receive conventional haematological care and the interventional arm will benefit in addition to a monthly consultation by a palliative care team.', 'armGroupLabels': ['Conventional care associated with a monthly consultation', 'Conventional haematological care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73000', 'city': 'Chambéry', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent SUTTON', 'role': 'CONTACT'}, {'name': 'Laurent SUTTON', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Matthieu CRETINON', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Métropole Savoie', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lise LACLAUTRE', 'role': 'CONTACT', 'email': 'drci@chu-clermontferrand.fr', 'phone': '0473754963'}, {'name': 'Virginie GUASTELLA', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jacques-Olivier BAY', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Chu Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '87042', 'city': 'Limoges', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stéphane MOREAU', 'role': 'CONTACT'}, {'name': 'Stéphane MOREAU', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Bertrand SARDIN', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Chu Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '69008', 'city': 'Lyon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne-Sophie MICHALLET', 'role': 'CONTACT'}, {'name': 'Anne-Sophie MICHALLET', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gisèle CHVETZOF', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '42271', 'city': 'Saint-Priest-en-Jarez', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Denis GUYOTAT', 'role': 'CONTACT'}, {'name': 'Denis GUYOTAT', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Stéphanie MORISSON', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Institut de Cancérologie de la Loire', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}, {'zip': '03200', 'city': 'Vichy', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Karine SOULIER-GUERIN', 'role': 'CONTACT'}, {'name': 'Karine SOULIER-GUERIN', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Franck DELPRETTI', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CH Jacques Lacarin', 'geoPoint': {'lat': 46.12709, 'lon': 3.42577}}], 'centralContacts': [{'name': 'Lise LACLAUTRE', 'role': 'CONTACT', 'email': 'drci@chu-clermontferrand.fr', 'phone': '0473754963'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondation Apicil', 'class': 'OTHER'}, {'name': 'Association des foulées de la Haute Lozère', 'class': 'UNKNOWN'}, {'name': 'Association CEMSBM', 'class': 'UNKNOWN'}, {'name': 'Connaître et Combattre les Myélodysplasies', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}