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Early Palliative Care for Patients With Haematological Malignancies (CALVI)

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ClinicalTrials.gov Identifier: NCT03800095
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : March 24, 2021
Sponsor:
Collaborators:
Fondation Apicil
Association des foulées de la Haute Lozère
Association CEMSBM
Connaître et Combattre les Myélodysplasies
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:

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.

Investigator 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 .


Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Myelodysplastic Syndrome Diffuse Large B Cell Lymphoma Palliative Care Drug: Early palliative care integration Phase 3

Detailed Description:

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.

Investigator 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 .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: no masking
Primary Purpose: Treatment
Official Title: Early Palliative Care for Patients With Haematological Malignancies: A Randomised Prospective Study
Actual Study Start Date : March 14, 2019
Estimated Primary Completion Date : August 14, 2023
Estimated Study Completion Date : December 31, 2023


Arm Intervention/treatment
Experimental: Conventional haematological care
Patients with haematological malignancy Conventional haematological care
Drug: Early palliative care integration
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.

Experimental: Conventional care associated with a monthly consultation
Patients with haematological malignancy Conventional care associated with a monthly consultation realized by a palliative and supportive care team
Drug: Early palliative care integration
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.




Primary Outcome Measures :
  1. Quality of life evaluation: standardized questionnaire [ Time Frame: at 6 months ]
    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].


Secondary Outcome Measures :
  1. Presence of discomfort symptoms [ Time Frame: at Day 0, 3 months, 6 months, 9 months, 12 months ]
    evaluated by Edmonton scale (depressive syndrome measured by the geriatric depression scale GDS)

  2. overall survival [ Time Frame: at day 1 : from the randomization until the date of death or until 1 year [study end]. ]
  3. Satisfaction of the care pathwaydesired by the patient [ Time Frame: at 12 months or death ]
    matching between patients desires writing in the medical file and the providing care

  4. cost-effectiveness analysis [ Time Frame: at 12 months or death ]
    The cost criteria selected will be all the direct medical costs inherent in care in both arms (costs of hospitalizations, consultations, treatments, medical devices).



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients are over 70 years old
  • Patients from being diagnosed with acute myeloid leukemia and high-risk myelodysplastic syndrome or after the third line of therapy for high-grade lymphoma.

Exclusion Criteria:

  • All patients with a curative project (induction chemotherapy ou allogenic transplantation)
  • All patients in a terminal palliative status
  • Patients who don't speak French,
  • Patients not able to read and write
  • Patients who don't agree to participate in the protocol
  • Patients with psychiatric troubles or cognitive disorders
  • Patients under guardianship or curatorship, deprived of freedom or under justice protection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800095


Contacts
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Contact: Lise LACLAUTRE 0473754963 drci@chu-clermontferrand.fr

Locations
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France
Centre Hospitalier Métropole Savoie Not yet recruiting
Chambéry, France, 73000
Contact: Laurent SUTTON         
Principal Investigator: Laurent SUTTON         
Sub-Investigator: Matthieu CRETINON         
Chu Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Lise LACLAUTRE    0473754963    drci@chu-clermontferrand.fr   
Principal Investigator: Virginie GUASTELLA         
Sub-Investigator: Jacques-Olivier BAY         
Chu Limoges Recruiting
Limoges, France, 87042
Contact: Stéphane MOREAU         
Principal Investigator: Stéphane MOREAU         
Sub-Investigator: Bertrand SARDIN         
Centre Léon Bérard Not yet recruiting
Lyon, France, 69008
Contact: Anne-Sophie MICHALLET         
Principal Investigator: Anne-Sophie MICHALLET         
Sub-Investigator: Gisèle CHVETZOF         
Institut de Cancérologie de la Loire Recruiting
Saint-Priest-en-Jarez, France, 42271
Contact: Denis GUYOTAT         
Principal Investigator: Denis GUYOTAT         
Sub-Investigator: Stéphanie MORISSON         
CH Jacques Lacarin Not yet recruiting
Vichy, France, 03200
Contact: Karine SOULIER-GUERIN         
Principal Investigator: Karine SOULIER-GUERIN         
Sub-Investigator: Franck DELPRETTI         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Fondation Apicil
Association des foulées de la Haute Lozère
Association CEMSBM
Connaître et Combattre les Myélodysplasies
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03800095    
Other Study ID Numbers: CHU-406
2017-A02515-48 ( Other Identifier: 2017-A02515-48 )
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: March 24, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
Supportive care
Early palliative care
Quality of life
Symptoms management
Haematological malignancy
Additional relevant MeSH terms:
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Neoplasms
Lymphoma, Large B-Cell, Diffuse
Hematologic Neoplasms
Myelodysplastic Syndromes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site