Feasibility Study of Tripartite Prehabilitation of Patients With Acute Myeloid Leukaemia and High-risk Myelodysplastic Syndromes During Intensive Chemotherapy Before Allogenic Haematopoietic Stem Cell Transplantation: the COHABILIT Protocol

Institut Paoli-Calmettes1 site in 1 country50 target enrollmentApril 4, 2022

ConditionsAcute Myeloid Leukemia Myelodysplastic Syndromes

Overview

Phase: N/A
Intervention: Not specified
Conditions: Acute Myeloid Leukemia
Sponsor: Institut Paoli-Calmettes
Enrollment: 50
Locations: 1
Primary Endpoint: feasibility to the adapted multidisciplinary program
Status: Active, Not Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

April 4, 2022

End Date

May 4, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Institut Paoli-Calmettes

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

feasibility to the adapted multidisciplinary program

Time Frame: 6 months

proportion of patients who will complete more than 50% of the APA/coaching sessions prescribed

Secondary Outcomes

Evaluate correlation between APA coaching sessions undertaken and fatigue(6 months)
evaluate number of days of hospitalisation(6 months)
evaluate cause of overall mortality(6 months)
Evaluation of the severity of digestive GVH disease(6 monts)
Evaluate changes in upper limb strengt(6 months)
evalaute number of patients disqualified for allotransplant(6 monts)
Evaluate physical activity sessions modalities(6 months)
Evaluate positive and negative affect(6 months)
Evaluate body mass index(6 months)
Evaluate muscle mass(6 months)
- Evaluate number of infections documented(6 months)
Evaluate the quality of the trainer-trainee relationship(6 months)
Evaluate QoL(6 months)
Evaluate correlation between APA coaching sessions undertaken and QoL(6 months)
Evaluate change in functional capacity(6 months)
Evaluate physical activity sessions feasability(6 months)
Evaluate changes in weight(6 months)
evaluate rate of overall mortality(30 days)
Evaluate rate of non relapse Mortality (RNM)(6 months)
evaluate survival without events(6 monts)
Evaluate changes in lower limb strength(6 months)
Evaluate self-efficacy(6 months)
Evaluate correlation between APA coaching sessions undertaken and NRM(6 months)
Evaluate correlation between APA coaching sessions undertaken and survival(6 months)
Evaluate life satisfaction(6 months)
Evaluate the level of depression(6 months)
Evaluate relationship dynamics(6 months)
Evaluate the cancer related fatigue(6 months)
changes in impedancemetry data(6 months)
Evaluate fat mass(6 months)
Evaluate adherence to nutrition programme(6 months)
evaluate rate of early mortality(30 days)
degree of digestive GVH disease(6 monts)
Evaluate skeletal muscle mass index (SMI) change in the course of the treatment(6 months)
Complete remision(6 months)
evaluate overall survival(6 months)
Study correlation between variation in weight, BMI, muscle mass, fat mass and SMI on physical capacities, QoL, number of infections, number of days of hospitalisation, patients' outcomes (NRM, survival) and GvHD in allotransplant patients.(6 months)
evaluate survival without relapse(6 monts)
evaluate number of allotransplant patients(6 monts)