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Early Palliative Care for Patients With Haematological Malignancies (CALVI)

Primary Purpose

Acute Myeloid Leukemia, Myelodysplastic Syndrome, Diffuse Large B Cell Lymphoma

Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Early palliative care integration
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Supportive care, Early palliative care, Quality of life, Symptoms management, Haematological malignancy

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Hospitalier Métropole Savoie
  • Chu Clermont-FerrandRecruiting
  • Chu LimogesRecruiting
  • Centre Léon Bérard
  • Institut de Cancérologie de la LoireRecruiting
  • CH Jacques Lacarin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Conventional haematological care

Conventional care associated with a monthly consultation

Arm Description

Patients with haematological malignancy Conventional haematological care

Patients with haematological malignancy Conventional care associated with a monthly consultation realized by a palliative and supportive care team

Outcomes

Primary Outcome Measures

Quality of life evaluation: standardized questionnaire
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

Presence of discomfort symptoms
evaluated by Edmonton scale (depressive syndrome measured by the geriatric depression scale GDS)
overall survival
Satisfaction of the care pathwaydesired by the patient
matching between patients desires writing in the medical file and the providing care
cost-effectiveness analysis
The cost criteria selected will be all the direct medical costs inherent in care in both arms (costs of hospitalizations, consultations, treatments, medical devices).

Full Information

First Posted
September 13, 2018
Last Updated
March 23, 2021
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Fondation Apicil, Association des foulées de la Haute Lozère, Association CEMSBM, Connaître et Combattre les Myélodysplasies
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1. Study Identification

Unique Protocol Identification Number
NCT03800095
Brief Title
Early Palliative Care for Patients With Haematological Malignancies
Acronym
CALVI
Official Title
Early Palliative Care for Patients With Haematological Malignancies: A Randomised Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2019 (Actual)
Primary Completion Date
August 14, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Fondation Apicil, Association des foulées de la Haute Lozère, Association CEMSBM, Connaître et Combattre les Myélodysplasies

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 .
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Myelodysplastic Syndrome, Diffuse Large B Cell Lymphoma, Palliative Care
Keywords
Supportive care, Early palliative care, Quality of life, Symptoms management, Haematological malignancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
no masking
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional haematological care
Arm Type
Experimental
Arm Description
Patients with haematological malignancy Conventional haematological care
Arm Title
Conventional care associated with a monthly consultation
Arm Type
Experimental
Arm Description
Patients with haematological malignancy Conventional care associated with a monthly consultation realized by a palliative and supportive care team
Intervention Type
Drug
Intervention Name(s)
Early palliative care integration
Intervention 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.
Primary Outcome Measure Information:
Title
Quality of life evaluation: standardized questionnaire
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].
Time Frame
at 6 months
Secondary Outcome Measure Information:
Title
Presence of discomfort symptoms
Description
evaluated by Edmonton scale (depressive syndrome measured by the geriatric depression scale GDS)
Time Frame
at Day 0, 3 months, 6 months, 9 months, 12 months
Title
overall survival
Time Frame
at day 1 : from the randomization until the date of death or until 1 year [study end].
Title
Satisfaction of the care pathwaydesired by the patient
Description
matching between patients desires writing in the medical file and the providing care
Time Frame
at 12 months or death
Title
cost-effectiveness analysis
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).
Time Frame
at 12 months or death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise LACLAUTRE
Phone
0473754963
Email
drci@chu-clermontferrand.fr
Facility Information:
Facility Name
Centre Hospitalier Métropole Savoie
City
Chambéry
ZIP/Postal Code
73000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent SUTTON
First Name & Middle Initial & Last Name & Degree
Laurent SUTTON
First Name & Middle Initial & Last Name & Degree
Matthieu CRETINON
Facility Name
Chu Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise LACLAUTRE
Phone
0473754963
Email
drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Virginie GUASTELLA
First Name & Middle Initial & Last Name & Degree
Jacques-Olivier BAY
Facility Name
Chu Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane MOREAU
First Name & Middle Initial & Last Name & Degree
Stéphane MOREAU
First Name & Middle Initial & Last Name & Degree
Bertrand SARDIN
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Sophie MICHALLET
First Name & Middle Initial & Last Name & Degree
Anne-Sophie MICHALLET
First Name & Middle Initial & Last Name & Degree
Gisèle CHVETZOF
Facility Name
Institut de Cancérologie de la Loire
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42271
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denis GUYOTAT
First Name & Middle Initial & Last Name & Degree
Denis GUYOTAT
First Name & Middle Initial & Last Name & Degree
Stéphanie MORISSON
Facility Name
CH Jacques Lacarin
City
Vichy
ZIP/Postal Code
03200
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karine SOULIER-GUERIN
First Name & Middle Initial & Last Name & Degree
Karine SOULIER-GUERIN
First Name & Middle Initial & Last Name & Degree
Franck DELPRETTI

12. IPD Sharing Statement

Learn more about this trial

Early Palliative Care for Patients With Haematological Malignancies

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