COaching and Prehabilitation: Faisability Study in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
- Conditions
- Acute Myeloid LeukemiaMyelodysplastic Syndromes
- Interventions
- Procedure: Coaching and Habilitation
- Registration Number
- NCT03595787
- Lead Sponsor
- Institut Paoli-Calmettes
- Brief Summary
This faisability study aims to evaluate the adhesion of the patient to a multidisciplinary program (adapted physical activity, coaching and nutrition)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Prehabilitation program Coaching and Habilitation 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
- Primary Outcome Measures
Name Time Method feasibility to the adapted multidisciplinary program 6 months proportion of patients who will complete more than 50% of the APA/coaching sessions prescribed
- Secondary Outcome Measures
Name Time Method Evaluate correlation between APA coaching sessions undertaken and fatigue 6 months Correlation between number of APA sessions and Fact-Fa
evaluate number of days of hospitalisation 6 months number of days of hospitalisation mesured in nights
evaluate cause of overall mortality 6 months cause of premature mortality
Evaluate changes in upper limb strengt 6 months Prehension strength with handgrip
evalaute number of patients disqualified for allotransplant 6 monts number of patients with transplant indication disqualified for allotransplant
Evaluate physical activity sessions modalities 6 months Data from connected watch
Evaluate positive and negative affect 6 months Outcomes of questionaries : PANAS,
Evaluate body mass index 6 months Change in body mass index (BMI= Weight/Height²)
Evaluate muscle mass 6 months Change in muscle mass (impedancemetry data via connected weighing machine)
- Evaluate number of infections documented 6 months number of infections documented
Evaluate the quality of the trainer-trainee relationship 6 months Outcomes of questionaries CART-Q
Evaluate QoL 6 months Outcomes of questionaries FACT-Leu
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 physical activity sessions feasability 6 months Number of sessions not undertaken and reason for refusal
Evaluate changes in weight 6 months Change in weight (impedancemetry data via connected weighing machine)
evaluate rate of overall mortality 30 days rate of overall mortality
Evaluate rate of non relapse Mortality (RNM) 6 months Rate of NRM
evaluate survival without events 6 monts survival without events rate
Evaluation of the severity of digestive GVH disease 6 monts severity of GVH desease
Evaluate changes in lower limb strength 6 months Quadriceps strength with dynamometer
Evaluate self-efficacy 6 months Outcomes of questionaries Self-efficacy
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 survival 6 months Correlation between number of APA sessions and survival rates
Evaluate life satisfaction 6 months Outcomes of questionaries LSS
Evaluate the level of depression 6 months Outcomes of questionaries HADS
Evaluate relationship dynamics 6 months Semi-directive interviews
Evaluate the cancer related fatigue 6 months Outcomes of questionaries FACT-Fa
changes in impedancemetry data 6 months Impedaneimetry mesures (connected weighing machine): body mass index variations,
Evaluate fat mass 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
evaluate rate of early mortality 30 days rate of premature mortality
degree of digestive GVH disease 6 monts GVH disease grade
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)
Complete remision 6 months Complete remision rate
evaluate overall survival 6 months overal survival rate
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
evaluate survival without relapse 6 monts survival without relapse rate
evaluate number of allotransplant patients 6 monts number of allotransplant patients
Trial Locations
- Locations (1)
Institut Paoli Calmettes
🇫🇷Marseille, France