Early Palliative Care for Patients With Haematological Malignancies (CALVI)

March 23, 2021 updated by: University Hospital, Clermont-Ferrand

Early Palliative Care for Patients With Haematological Malignancies: A Randomised Prospective Study

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 .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Chambéry, France, 73000
        • Not yet recruiting
        • Centre Hospitalier Métropole Savoie
        • Contact:
          • Laurent SUTTON
        • Principal Investigator:
          • Laurent SUTTON
        • Sub-Investigator:
          • Matthieu CRETINON
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • Chu Clermont-Ferrand
        • Contact:
        • Principal Investigator:
          • Virginie Guastella
        • Sub-Investigator:
          • Jacques-Olivier BAY
      • Limoges, France, 87042
        • Recruiting
        • CHU Limoges
        • Principal Investigator:
          • Stéphane MOREAU
        • Contact:
          • Stéphane MOREAU
        • Sub-Investigator:
          • Bertrand SARDIN
      • Lyon, France, 69008
        • Not yet recruiting
        • Centre Leon Berard
        • Contact:
          • Anne-Sophie MICHALLET
        • Sub-Investigator:
          • Gisèle CHVETZOF
      • Saint-Priest-en-Jarez, France, 42271
        • Recruiting
        • Institut de Cancerologie de La Loire
        • Contact:
          • Denis Guyotat
        • Sub-Investigator:
          • Stéphanie MORISSON
      • Vichy, France, 03200
        • Not yet recruiting
        • CH Jacques Lacarin
        • Contact:
          • Karine SOULIER-GUERIN
        • Principal Investigator:
          • Karine SOULIER-GUERIN
        • Sub-Investigator:
          • Franck DELPRETTI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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].
at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
at Day 0, 3 months, 6 months, 9 months, 12 months
overall survival
Time Frame: at day 1 : from the randomization until the date of death or until 1 year [study end].
at day 1 : from the randomization until the date of death or until 1 year [study end].
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
at 12 months or death
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).
at 12 months or death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Fondation Apicil
Association des foulées de la Haute Lozère
Association CEMSBM
Connaître et Combattre les Myélodysplasies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2019

Primary Completion (Anticipated)

August 14, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

September 13, 2018

First Submitted That Met QC Criteria

January 10, 2019

First Posted (Actual)

January 11, 2019

Study Record Updates

Last Update Posted (Actual)

March 24, 2021

Last Update Submitted That Met QC Criteria

March 23, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-406
  • 2017-A02515-48 (Other Identifier: 2017-A02515-48)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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