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

N/AActive Not RecruitingNCT03595787

Institut Paoli-Calmettes50 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Acute Myeloid Leukemia Myelodysplastic Syndromes

Interventions

Coaching and HabilitationPROCEDURE

nutritional support, adapted physical activity and coaching

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Institut Paoli Calmettes

Marseille, France

Outcomes

Primary Outcomes

feasibility to the adapted multidisciplinary program

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

Time frame: 6 months

Secondary Outcomes

Evaluate change in functional capacity

Test SPPB

Time frame: 6 months

Evaluate changes in upper limb strengt

Prehension strength with handgrip

Time frame: 6 months

Evaluate changes in lower limb strength

Quadriceps strength with dynamometer

Time frame: 6 months

Evaluate physical activity sessions modalities

Data from connected watch

Time frame: 6 months

Evaluate physical activity sessions feasability

Number of sessions not undertaken and reason for refusal

Time frame: 6 months

Evaluate positive and negative affect

Outcomes of questionaries : PANAS,

Time frame: 6 months

Evaluate life satisfaction

Outcomes of questionaries LSS

Time frame: 6 months

Evaluate the level of depression

Outcomes of questionaries HADS

Data from ClinicalTrials.gov

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Time frame: 6 months

Evaluate the quality of the trainer-trainee relationship

Outcomes of questionaries CART-Q

Time frame: 6 months

Evaluate self-efficacy

Outcomes of questionaries Self-efficacy

Time frame: 6 months

Evaluate relationship dynamics

Semi-directive interviews

Time frame: 6 months

Evaluate QoL

Outcomes of questionaries FACT-Leu

Time frame: 6 months

Evaluate the cancer related fatigue

Outcomes of questionaries FACT-Fa

Time frame: 6 months

Evaluate correlation between APA coaching sessions undertaken and NRM

Correlation between number of APA sessions and NRM

Time frame: 6 months

Evaluate correlation between APA coaching sessions undertaken and survival

Correlation between number of APA sessions and survival rates

Time frame: 6 months

Evaluate correlation between APA coaching sessions undertaken and QoL

Correlation between number of APA sessions and Fact-Leu

Time frame: 6 months

Evaluate correlation between APA coaching sessions undertaken and fatigue

Correlation between number of APA sessions and Fact-Fa

Time frame: 6 months

Evaluate changes in weight

Change in weight (impedancemetry data via connected weighing machine)

Time frame: 6 months

Evaluate body mass index

Change in body mass index (BMI= Weight/Height²)

Time frame: 6 months

changes in impedancemetry data

Impedaneimetry mesures (connected weighing machine): body mass index variations,

Time frame: 6 months

Evaluate muscle mass

Change in muscle mass (impedancemetry data via connected weighing machine)

Time frame: 6 months

Evaluate fat mass

Abdominal scan by L3 cross-section: Skeletal Muscle Mass Index (SMI= skeletal muscle mass/height)

Time frame: 6 months

Evaluate skeletal muscle mass index (SMI) change in the course of the treatment

Abdominal scan by L3 cross-section: Skeletal Muscle Mass Index (SMI= skeletal muscle mass/height)

Time frame: 6 months

Evaluate adherence to nutrition programme

Number of days enteral and parenteral nutrition

Time frame: 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.

Correlation between variation in weight, BMI, muscle mass, fat mass and SMI with NRM, overall survival, number of days of hospitalisation, number of infections documented, QoL, physical capacities and GvHD

Time frame: 6 months

Complete remision

Complete remision rate

Time frame: 6 months

- Evaluate number of infections documented

number of infections documented

Time frame: 6 months

evaluate number of days of hospitalisation

number of days of hospitalisation mesured in nights

Time frame: 6 months

evaluate rate of early mortality

rate of premature mortality

Time frame: 30 days

evaluate rate of overall mortality

rate of overall mortality

Time frame: 30 days

evaluate cause of overall mortality

cause of premature mortality

Time frame: 6 months

Evaluate rate of non relapse Mortality (RNM)

Rate of NRM

Time frame: 6 months

evaluate overall survival

overal survival rate

Time frame: 6 months

evaluate survival without relapse

survival without relapse rate

Time frame: 6 monts

evaluate survival without events

survival without events rate

Time frame: 6 monts

evaluate number of allotransplant patients

number of allotransplant patients

Time frame: 6 monts

evalaute number of patients disqualified for allotransplant

number of patients with transplant indication disqualified for allotransplant

Time frame: 6 monts

degree of digestive GVH disease

GVH disease grade

Time frame: 6 monts

Evaluation of the severity of digestive GVH disease

severity of GVH desease

Time frame: 6 monts