Early Palliative Care for Patients With Haematological Malignancies (CALVI)

University Hospital, Clermont-Ferrand

Status and phase: Unknown; Phase 3

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

Treatments: Drug: Early palliative care integration

Study type: Interventional

Funder types: Other

Identifiers

NCT03800095

2017-A02515-48 (Other Identifier)

CHU-406

Details and patient eligibility

About

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 .

Full 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 .

Enrollment: 140 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Conventional haematological care

Experimental group

Description:

Patients with haematological malignancy Conventional haematological care

Treatment:

Drug: Early palliative care integration

Conventional care associated with a monthly consultation

Experimental group

Description:

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

Treatment:

Drug: Early palliative care integration