Early Palliative Care for Patients With Haematological Malignancies

Phase 3

• Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndrome; Palliative Care; Diffuse Large B Cell Lymphoma
• Interventions: Drug: Early palliative care integration

• Registration Number: NCT03800095
• Lead Sponsor: 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 .

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 Timeline

• Study First Submitted: 2018-09-13
• Study First Submitted QC: 2019-01-10
• Study First Posted: 2019-01-11
• Study Start: 2019-03-14
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-23
• Last Update Posted: 2021-03-24
• Primary Completion: 2023-08-14
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional haematological care	Early palliative care integration	Patients with haematological malignancy Conventional haematological care
Conventional care associated with a monthly consultation	Early palliative care integration	Patients with haematological malignancy Conventional care associated with a monthly consultation realized by a palliative and supportive care team

Primary Outcome Measures

Name	Time	Method
Quality of life evaluation: standardized questionnaire	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

Name	Time	Method
Presence of discomfort symptoms	at Day 0, 3 months, 6 months, 9 months, 12 months	evaluated by Edmonton scale (depressive syndrome measured by the geriatric depression scale GDS)
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	matching between patients desires writing in the medical file and the providing care
cost-effectiveness analysis	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).

Trial Locations

Locations (6)

CH Jacques Lacarin; 🇫🇷 Vichy, France

Centre Hospitalier Métropole Savoie; 🇫🇷 Chambéry, France

Chu Limoges; 🇫🇷 Limoges, France

Chu Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Centre Léon Bérard; 🇫🇷 Lyon, France

Institut de Cancérologie de la Loire; 🇫🇷 Saint-Priest-en-Jarez, France