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NCT Number: NCT03595787

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Acute Myeloid Leukemia Behavior Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Motor Activity Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Paoli Calmettes

Marseille, 13009, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Coaching and Habilitation

Procedure

nutritional support, adapted physical activity and coaching

Primary outcomes

  1. feasibility to the adapted multidisciplinary program

    Time frame: 6 months

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

Secondary outcomes

  1. Evaluate change in functional capacity

    Time frame: 6 months

    Test SPPB

  2. Evaluate changes in upper limb strengt

    Time frame: 6 months

    Prehension strength with handgrip

  3. Evaluate changes in lower limb strength

    Time frame: 6 months

    Quadriceps strength with dynamometer

  4. Evaluate physical activity sessions modalities

    Time frame: 6 months

    Data from connected watch

  5. Evaluate physical activity sessions feasability

    Time frame: 6 months

    Number of sessions not undertaken and reason for refusal

  6. Evaluate positive and negative affect

    Time frame: 6 months

    Outcomes of questionaries : PANAS,

  7. Evaluate life satisfaction

    Time frame: 6 months

    Outcomes of questionaries LSS

  8. Evaluate the level of depression

    Time frame: 6 months

    Outcomes of questionaries HADS

  9. Evaluate the quality of the trainer-trainee relationship

    Time frame: 6 months

    Outcomes of questionaries CART-Q

  10. Evaluate self-efficacy

    Time frame: 6 months

    Outcomes of questionaries Self-efficacy

  11. Evaluate relationship dynamics

    Time frame: 6 months

    Semi-directive interviews

  12. Evaluate QoL

    Time frame: 6 months

    Outcomes of questionaries FACT-Leu

  13. Evaluate the cancer related fatigue

    Time frame: 6 months

    Outcomes of questionaries FACT-Fa

  14. Evaluate correlation between APA coaching sessions undertaken and NRM

    Time frame: 6 months

    Correlation between number of APA sessions and NRM

  15. Evaluate correlation between APA coaching sessions undertaken and survival

    Time frame: 6 months

    Correlation between number of APA sessions and survival rates

  16. Evaluate correlation between APA coaching sessions undertaken and QoL

    Time frame: 6 months

    Correlation between number of APA sessions and Fact-Leu

  17. Evaluate correlation between APA coaching sessions undertaken and fatigue

    Time frame: 6 months

    Correlation between number of APA sessions and Fact-Fa

  18. Evaluate changes in weight

    Time frame: 6 months

    Change in weight (impedancemetry data via connected weighing machine)

  19. Evaluate body mass index

    Time frame: 6 months

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

  20. changes in impedancemetry data

    Time frame: 6 months

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

  21. Evaluate muscle mass

    Time frame: 6 months

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

  22. Evaluate fat mass

    Time frame: 6 months

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

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

    Time frame: 6 months

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

  24. Evaluate adherence to nutrition programme

    Time frame: 6 months

    Number of days enteral and parenteral nutrition

  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.

    Time frame: 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

  26. Complete remision

    Time frame: 6 months

    Complete remision rate

  27. - Evaluate number of infections documented

    Time frame: 6 months

    number of infections documented

  28. evaluate number of days of hospitalisation

    Time frame: 6 months

    number of days of hospitalisation mesured in nights

  29. evaluate rate of early mortality

    Time frame: 30 days

    rate of premature mortality

  30. evaluate rate of overall mortality

    Time frame: 30 days

    rate of overall mortality

  31. evaluate cause of overall mortality

    Time frame: 6 months

    cause of premature mortality

  32. Evaluate rate of non relapse Mortality (RNM)

    Time frame: 6 months

    Rate of NRM

  33. evaluate overall survival

    Time frame: 6 months

    overal survival rate

  34. evaluate survival without relapse

    Time frame: 6 monts

    survival without relapse rate

  35. evaluate survival without events

    Time frame: 6 monts

    survival without events rate

  36. evaluate number of allotransplant patients

    Time frame: 6 monts

    number of allotransplant patients

  37. evalaute number of patients disqualified for allotransplant

    Time frame: 6 monts

    number of patients with transplant indication disqualified for allotransplant

  38. degree of digestive GVH disease

    Time frame: 6 monts

    GVH disease grade

  39. Evaluation of the severity of digestive GVH disease

    Time frame: 6 monts

    severity of GVH desease

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Official study 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

Acronym: COHABILIT

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2018
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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