Early Palliative Care for Patients With Haematological Malignancies

Study Overview
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Brief Summary
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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
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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 .

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

Conditions
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Acute Myeloid Leukemia, Myelodysplastic Syndrome, Diffuse Large B Cell Lymphoma, Palliative Care

Intervention / Treatment
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* Drug: Early palliative care integration


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional haematological care<br>Patients with haematological malignancy Conventional haematological care | Drug: Early palliative care integration<br>* 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.<br>|
| Experimental: Conventional care associated with a monthly consultation<br>Patients with haematological malignancy Conventional care associated with a monthly consultation realized by a palliative and supportive care team | Drug: Early palliative care integration<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of discomfort symptoms | 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 |  | 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 | matching between patients desires writing in the medical file and the providing care | at 12 months or death | 
| 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). | at 12 months or death | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Supportive care, Early palliative care, Quality of life, Symptoms management, Haematological malignancy