Early Palliative Care for Patients With Haematological Malignancies

NCT ID: NCT03800095

Last Updated: 2021-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-14

Study Completion Date

2023-12-31

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 .

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

no masking

Study Groups

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Conventional haematological care

Patients with haematological malignancy Conventional haematological care

Group Type EXPERIMENTAL

Early palliative care integration

Intervention Type 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

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

Group Type EXPERIMENTAL

Early palliative care integration

Intervention Type 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.

Interventions

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Early palliative care integration

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.

Intervention Type DRUG

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.
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Apicil

OTHER

Sponsor Role collaborator

Association des foulées de la Haute Lozère

UNKNOWN

Sponsor Role collaborator

Association CEMSBM

UNKNOWN

Sponsor Role collaborator

Connaître et Combattre les Myélodysplasies

UNKNOWN

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Métropole Savoie

Chambéry, , France

Site Status NOT_YET_RECRUITING

Chu Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Chu Limoges

Limoges, , France

Site Status RECRUITING

Centre Léon Bérard

Lyon, , France

Site Status NOT_YET_RECRUITING

Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, , France

Site Status RECRUITING

CH Jacques Lacarin

Vichy, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Lise LACLAUTRE

Role: CONTACT

0473754963

Facility Contacts

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Laurent SUTTON

Role: primary

Lise LACLAUTRE

Role: primary

0473754963

Stéphane MOREAU

Role: primary

Anne-Sophie MICHALLET

Role: primary

Denis GUYOTAT

Role: primary

Karine SOULIER-GUERIN

Role: primary

Other Identifiers

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2017-A02515-48

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-406

Identifier Type: -

Identifier Source: org_study_id

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