COaching and Prehabilitation: Faisability Study in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

NCT ID: NCT03595787

Last Updated: 2024-12-18

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-04

Study Completion Date

2025-05-04

Brief Summary

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This faisability study aims to evaluate the adhesion of the patient to a multidisciplinary program (adapted physical activity, coaching and nutrition)

Detailed Description

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Conditions

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Acute Myeloid Leukemia Myelodysplastic Syndromes

Keywords

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prehabilitation coaching nutritional support physical activity allogeneic stem cells transplantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Prehabilitation program

Program based on nutritional support, physical activity program and coaching. Home-based monitoring will be done thanks to connected watches (step counter pedometer) and a connected body fat weight scale

Group Type EXPERIMENTAL

Coaching and Habilitation

Intervention Type PROCEDURE

nutritional support, adapted physical activity and coaching

Interventions

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Coaching and Habilitation

nutritional support, adapted physical activity and coaching

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of acute myeloid leukemia or high-risk myelodysplastic syndrome
* Age between 18 and 70 years
* Eligible for an intensive chemotherapy
* Eligible for allograft
* Able to answer a questionnaire

Exclusion Criteria

* Diagnosis of acute promyelocytic Leukemia
* Palliative treatment
* Contraindication to moderate physical activity
* Performans status 4, unless it is related to the disease
* Patient who does not understand French
* Patient unable to use a smartphone
* Patient deprived of liberty or placed under the authority of a tutor,
* Patient considered socially or psychologically unable to comply with the treatment and the required medical follow-up.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Paoli-Calmettes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cécile Bannier Braticevic, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Paoli-Calmettes

Locations

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Institut Paoli Calmettes

Marseille, , France

Site Status

Countries

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France

References

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Saillard C, Cuvelier S, Villaron-Goetgheluck C, Boher JM, Almeida-Lopez L, Le Corroller AG, Denis P, Rivieccio C, Calvin S, Vey N, Bannier-Braticevic C. Tripartite prehabilitation of patients with acute myeloid leukaemia and high-risk myelodysplastic syndromes during intensive chemotherapy before allogeneic haematopoietic stem cell transplantation (COHABILIT): protocol for an innovating prospective multicentre study. BMJ Open. 2024 Mar 29;14(3):e076321. doi: 10.1136/bmjopen-2023-076321.

Reference Type DERIVED
PMID: 38553062 (View on PubMed)

Other Identifiers

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COHABILIT-IPC 2017-046

Identifier Type: -

Identifier Source: org_study_id