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Active, not recruitingNCT03595787COHABILITUpdated Dec 18, 2024

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

An interventional study of Coaching and Habilitation in Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Institut Paoli-Calmettes. Active, not recruiting at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-12-18.

Sponsored by Institut Paoli-Calmettes · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Acute Myeloid Leukemia
  • Myelodysplastic Syndromes

Keywords

  • prehabilitation
  • coaching
  • nutritional support
  • physical activity
  • allogeneic stem cells transplantation
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's planned enrollment of 50 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Institut Paoli-Calmettes is the lead sponsor of 168 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Prehabilitation program

    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

    Procedure: Coaching and Habilitation

Interventions

  • ProcedureCoaching and Habilitation

    nutritional support, adapted physical activity and coaching

06

What researchers measure

Primary outcomes

  1. 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

  1. Evaluate change in functional capacity

    Test SPPB

    Time frame: 6 months

  2. Evaluate changes in upper limb strengt

    Prehension strength with handgrip

    Time frame: 6 months

  3. Evaluate changes in lower limb strength

    Quadriceps strength with dynamometer

    Time frame: 6 months

  4. Evaluate physical activity sessions modalities

    Data from connected watch

    Time frame: 6 months

  5. Evaluate physical activity sessions feasability

    Number of sessions not undertaken and reason for refusal

    Time frame: 6 months

  6. Evaluate positive and negative affect

    Outcomes of questionaries : PANAS,

    Time frame: 6 months

  7. Evaluate life satisfaction

    Outcomes of questionaries LSS

    Time frame: 6 months

  8. Evaluate the level of depression

    Outcomes of questionaries HADS

    Time frame: 6 months

  9. Evaluate the quality of the trainer-trainee relationship

    Outcomes of questionaries CART-Q

    Time frame: 6 months

  10. Evaluate self-efficacy

    Outcomes of questionaries Self-efficacy

    Time frame: 6 months

  11. Evaluate relationship dynamics

    Semi-directive interviews

    Time frame: 6 months

  12. Evaluate QoL

    Outcomes of questionaries FACT-Leu

    Time frame: 6 months

  13. Evaluate the cancer related fatigue

    Outcomes of questionaries FACT-Fa

    Time frame: 6 months

  14. Evaluate correlation between APA coaching sessions undertaken and NRM

    Correlation between number of APA sessions and NRM

    Time frame: 6 months

  15. Evaluate correlation between APA coaching sessions undertaken and survival

    Correlation between number of APA sessions and survival rates

    Time frame: 6 months

  16. Evaluate correlation between APA coaching sessions undertaken and QoL

    Correlation between number of APA sessions and Fact-Leu

    Time frame: 6 months

  17. Evaluate correlation between APA coaching sessions undertaken and fatigue

    Correlation between number of APA sessions and Fact-Fa

    Time frame: 6 months

  18. Evaluate changes in weight

    Change in weight (impedancemetry data via connected weighing machine)

    Time frame: 6 months

  19. Evaluate body mass index

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

    Time frame: 6 months

  20. changes in impedancemetry data

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

    Time frame: 6 months

  21. Evaluate muscle mass

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

    Time frame: 6 months

  22. Evaluate fat mass

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

    Time frame: 6 months

  23. 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

  24. Evaluate adherence to nutrition programme

    Number of days enteral and parenteral nutrition

    Time frame: 6 months

  25. 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

  26. Complete remision

    Complete remision rate

    Time frame: 6 months

  27. - Evaluate number of infections documented

    number of infections documented

    Time frame: 6 months

  28. evaluate number of days of hospitalisation

    number of days of hospitalisation mesured in nights

    Time frame: 6 months

  29. evaluate rate of early mortality

    rate of premature mortality

    Time frame: 30 days

  30. evaluate rate of overall mortality

    rate of overall mortality

    Time frame: 30 days

  31. evaluate cause of overall mortality

    cause of premature mortality

    Time frame: 6 months

  32. Evaluate rate of non relapse Mortality (RNM)

    Rate of NRM

    Time frame: 6 months

  33. evaluate overall survival

    overal survival rate

    Time frame: 6 months

  34. evaluate survival without relapse

    survival without relapse rate

    Time frame: 6 monts

  35. evaluate survival without events

    survival without events rate

    Time frame: 6 monts

  36. evaluate number of allotransplant patients

    number of allotransplant patients

    Time frame: 6 monts

  37. evalaute number of patients disqualified for allotransplant

    number of patients with transplant indication disqualified for allotransplant

    Time frame: 6 monts

  38. degree of digestive GVH disease

    GVH disease grade

    Time frame: 6 monts

  39. Evaluation of the severity of digestive GVH disease

    severity of GVH desease

    Time frame: 6 monts

07

Study locations

1 site
  • Institut Paoli Calmettes
    Marseille, 13009, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03595787
Lead sponsor
Institut Paoli-Calmettes
Responsible party
Sponsor
First posted
Jul 23, 2018
Start date
Apr 4, 2022
Primary completion
May 4, 2025 (estimated)
Completion
May 4, 2025 (estimated)
Last update
Dec 18, 2024

Study contacts

Cécile Bannier Braticevic, MD
principal investigator · Institut Paoli-Calmettes

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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