Early Palliative Care for Patients With Haematological Malignancies

NCT03800095 | Unknown Phase 3

• 2 other identifiers: CHU-4062017-A02515-48
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 6

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 .

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 \[score range 0-188\].

  at 6 months

Secondary Outcomes (4)

• Presence of discomfort symptoms

  at Day 0, 3 months, 6 months, 9 months, 12 months

• overall survival

  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

  at 12 months or death

• cost-effectiveness analysis

  at 12 months or death

Study Arms (2)

Conventional haematological care

EXPERIMENTAL

Patients with haematological malignancy Conventional haematological care

Drug: Early palliative care integration

Conventional care associated with a monthly consultation

EXPERIMENTAL

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

Drug: Early palliative care integration

Interventions

Early palliative care integration DRUG

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.

Conventional care associated with a monthly consultation; Conventional haematological care

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Fondation Apicil: collaborator
• Association des foulées de la Haute Lozère: collaborator
• Association CEMSBM: collaborator
• Connaître et Combattre les Myélodysplasies: collaborator

Study Sites (6)

Centre Hospitalier Métropole Savoie

Chambéry, 73000, France

NOT YET RECRUITING

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Chu Limoges

Limoges, 87042, France

RECRUITING

Centre Léon Bérard

Lyon, 69008, France

NOT YET RECRUITING

Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, 42271, France

RECRUITING

CH Jacques Lacarin

Vichy, 03200, France

NOT YET RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Lymphoma, Large B-Cell, Diffuse; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms by Site

Central Study Contacts

Lise LACLAUTRE

CONTACT

0473754963; drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: no masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: January 11, 2019
• Study Start: March 14, 2019
• Primary Completion: August 14, 2023
• Study Completion: December 31, 2023
• Last Updated: March 24, 2021

Record last verified: 2021-03

Locations

FR (6)