Clinical trial NCT03595787: COaching and Prehabilitation: Faisability Study in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndromes
Keywords: prehabilitation
coaching
nutritional support
physical activity
allogeneic stem cells transplantation
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2018-07-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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


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.

Primary outcomes:
measure: feasibility to the adapted multidisciplinary program
timeFrame: 6 months
Secondary outcomes:
measure: Evaluate change in functional capacity
timeFrame: 6 months
measure: Evaluate changes in upper limb strengt
timeFrame: 6 months
measure: Evaluate changes in lower limb strength
timeFrame: 6 months
measure: Evaluate physical activity sessions modalities
timeFrame: 6 months
measure: Evaluate physical activity sessions feasability
timeFrame: 6 months
measure: Evaluate positive and negative affect
timeFrame: 6 months
measure: Evaluate life satisfaction
timeFrame: 6 months
measure: Evaluate the level of depression
timeFrame: 6 months
measure: Evaluate the quality of the trainer-trainee relationship
timeFrame: 6 months
measure: Evaluate self-efficacy
timeFrame: 6 months
measure: Evaluate relationship dynamics
timeFrame: 6 months
measure: Evaluate QoL
timeFrame: 6 months
measure: Evaluate the cancer related fatigue
timeFrame: 6 months
measure: Evaluate correlation between APA coaching sessions undertaken and NRM
timeFrame: 6 months
measure: Evaluate correlation between APA coaching sessions undertaken and survival
timeFrame: 6 months
measure: Evaluate correlation between APA coaching sessions undertaken and QoL
timeFrame: 6 months
measure: Evaluate correlation between APA coaching sessions undertaken and fatigue
timeFrame: 6 months
measure: Evaluate changes in weight
timeFrame: 6 months
measure: Evaluate body mass index
timeFrame: 6 months
measure: changes in impedancemetry data
timeFrame: 6 months
measure: Evaluate muscle mass
timeFrame: 6 months
measure: Evaluate fat mass
timeFrame: 6 months
measure: Evaluate skeletal muscle mass index (SMI) change in the course of the treatment
timeFrame: 6 months
measure: Evaluate adherence to nutrition programme
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
measure: Complete remision
timeFrame: 6 months
measure: - Evaluate number of infections documented
timeFrame: 6 months
measure: evaluate number of days of hospitalisation
timeFrame: 6 months
measure: evaluate rate of early mortality
timeFrame: 30 days
measure: evaluate rate of overall mortality
timeFrame: 30 days
measure: evaluate cause of overall mortality
timeFrame: 6 months
measure: Evaluate rate of non relapse Mortality (RNM)
timeFrame: 6 months
measure: evaluate overall survival
timeFrame: 6 months
measure: evaluate survival without relapse
timeFrame: 6 monts
measure: evaluate survival without events
timeFrame: 6 monts
measure: evaluate number of allotransplant patients
timeFrame: 6 monts
measure: evalaute number of patients disqualified for allotransplant
timeFrame: 6 monts
measure: degree of digestive GVH disease
timeFrame: 6 monts
measure: Evaluation of the severity of digestive GVH disease
timeFrame: 6 monts
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
Study officials:
affiliation: Institut Paoli-Calmettes
name: Cécile Bannier Braticevic, MD
role: PRINCIPAL_INVESTIGATOR
References: