Clinical trial NCT03800095: Early Palliative Care for Patients With Haematological Malignancies
Official title: Early Palliative Care for Patients With Haematological Malignancies: A Randomised Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
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
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Fondation Apicil
name: Association des foulées de la Haute Lozère
name: Association CEMSBM
name: Connaître et Combattre les Myélodysplasies
First posted: 2019-01-11
Enrollment: 140
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

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.

Primary outcomes:
measure: Quality of life evaluation: standardized questionnaire
timeFrame: at 6 months
Secondary outcomes:
measure: Presence of discomfort symptoms
timeFrame: at Day 0, 3 months, 6 months, 9 months, 12 months
measure: overall survival
timeFrame: at day 1 : from the randomization until the date of death or until 1 year [study end].
measure: Satisfaction of the care pathwaydesired by the patient
timeFrame: at 12 months or death
measure: cost-effectiveness analysis
timeFrame: at 12 months or death
Other outcomes:
Locations:
city: Chambéry
country: France
facility: Centre Hospitalier Métropole Savoie
city: Clermont-Ferrand
country: France
facility: Chu Clermont-Ferrand
city: Limoges
country: France
facility: Chu Limoges
city: Lyon
country: France
facility: Centre Léon Bérard
city: Saint-Priest-en-Jarez
country: France
facility: Institut de Cancérologie de la Loire
city: Vichy
country: France
facility: CH Jacques Lacarin
Study officials:
References: