Acute Myeloid Leukemia, Myelodysplastic Syndromes
Conditions
Keywords
prehabilitation, coaching, nutritional support, physical activity, allogeneic stem cells transplantation
Brief summary
This faisability study aims to evaluate the adhesion of the patient to a multidisciplinary program (adapted physical activity, coaching and nutrition)
Interventions
PROCEDURECoaching and Habilitation
nutritional support, adapted physical activity and coaching
Sponsors
Institut Paoli-Calmettes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| feasibility to the adapted multidisciplinary program | 6 months | proportion of patients who will complete more than 50% of the APA/coaching sessions prescribed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate self-efficacy | 6 months | Outcomes of questionaries Self-efficacy |
| Evaluate relationship dynamics | 6 months | Semi-directive interviews |
| Evaluate QoL | 6 months | Outcomes of questionaries FACT-Leu |
| Evaluate the cancer related fatigue | 6 months | Outcomes of questionaries FACT-Fa |
| Evaluate correlation between APA coaching sessions undertaken and NRM | 6 months | Correlation between number of APA sessions and NRM |
| Evaluate correlation between APA coaching sessions undertaken and QoL | 6 months | Correlation between number of APA sessions and Fact-Leu |
| Evaluate change in functional capacity | 6 months | Test SPPB |
| Evaluate changes in upper limb strengt | 6 months | Prehension strength with handgrip |
| Evaluate changes in lower limb strength | 6 months | Quadriceps strength with dynamometer |
| Evaluate physical activity sessions modalities | 6 months | Data from connected watch |
| Evaluate physical activity sessions feasability | 6 months | Number of sessions not undertaken and reason for refusal |
| Evaluate positive and negative affect | 6 months | Outcomes of questionaries : PANAS, |
| Evaluate life satisfaction | 6 months | Outcomes of questionaries LSS |
| Evaluate the level of depression | 6 months | Outcomes of questionaries HADS |
| Evaluate the quality of the trainer-trainee relationship | 6 months | Outcomes of questionaries CART-Q |
| Evaluate correlation between APA coaching sessions undertaken and fatigue | 6 months | Correlation between number of APA sessions and Fact-Fa |
| Evaluate changes in weight | 6 months | Change in weight (impedancemetry data via connected weighing machine) |
| Evaluate body mass index | 6 months | Change in body mass index (BMI= Weight/Height²) |
| changes in impedancemetry data | 6 months | Impedaneimetry mesures (connected weighing machine): body mass index variations, |
| Evaluate correlation between APA coaching sessions undertaken and survival | 6 months | Correlation between number of APA sessions and survival rates |
| Evaluate fat mass | 6 months | Abdominal scan by L3 cross-section: Skeletal Muscle Mass Index (SMI= skeletal muscle mass/height) |
| Evaluate skeletal muscle mass index (SMI) change in the course of the treatment | 6 months | Abdominal scan by L3 cross-section: Skeletal Muscle Mass Index (SMI= skeletal muscle mass/height) |
| Evaluate adherence to nutrition programme | 6 months | Number of days enteral and parenteral nutrition |
| 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 | 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 |
| Complete remision | 6 months | Complete remision rate |
| - Evaluate number of infections documented | 6 months | number of infections documented |
| evaluate number of days of hospitalisation | 6 months | number of days of hospitalisation mesured in nights |
| evaluate rate of early mortality | 30 days | rate of premature mortality |
| evaluate rate of overall mortality | 30 days | rate of overall mortality |
| evaluate cause of overall mortality | 6 months | cause of premature mortality |
| Evaluate rate of non relapse Mortality (RNM) | 6 months | Rate of NRM |
| evaluate overall survival | 6 months | overal survival rate |
| evaluate survival without relapse | 6 monts | survival without relapse rate |
| evaluate survival without events | 6 monts | survival without events rate |
| evaluate number of allotransplant patients | 6 monts | number of allotransplant patients |
| evalaute number of patients disqualified for allotransplant | 6 monts | number of patients with transplant indication disqualified for allotransplant |
| degree of digestive GVH disease | 6 monts | GVH disease grade |
| Evaluation of the severity of digestive GVH disease | 6 monts | severity of GVH desease |
| Evaluate muscle mass | 6 months | Change in muscle mass (impedancemetry data via connected weighing machine) |
Countries
France
Outcome results
None listed