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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndromes
• Intervention / Treatment: Procedure: Coaching and Habilitation

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13009
    • Institut Paoli Calmettes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; nutritional support, adapted physical activity and coaching

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
feasibility to the adapted multidisciplinary program	proportion of patients who will complete more than 50% of the APA/coaching sessions prescribed	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate change in functional capacity	Test SPPB	6 months
Evaluate changes in upper limb strengt	Prehension strength with handgrip	6 months
Evaluate changes in lower limb strength	Quadriceps strength with dynamometer	6 months
Evaluate physical activity sessions modalities	Data from connected watch	6 months
Evaluate physical activity sessions feasability	Number of sessions not undertaken and reason for refusal	6 months
Evaluate positive and negative affect	Outcomes of questionaries : PANAS,	6 months
Evaluate life satisfaction	Outcomes of questionaries LSS	6 months
Evaluate the level of depression	Outcomes of questionaries HADS	6 months
Evaluate the quality of the trainer-trainee relationship	Outcomes of questionaries CART-Q	6 months
Evaluate self-efficacy	Outcomes of questionaries Self-efficacy	6 months
Evaluate relationship dynamics	Semi-directive interviews	6 months
Evaluate QoL	Outcomes of questionaries FACT-Leu	6 months
Evaluate the cancer related fatigue	Outcomes of questionaries FACT-Fa	6 months
Evaluate correlation between APA coaching sessions undertaken and NRM	Correlation between number of APA sessions and NRM	6 months
Evaluate correlation between APA coaching sessions undertaken and survival	Correlation between number of APA sessions and survival rates	6 months
Evaluate correlation between APA coaching sessions undertaken and QoL	Correlation between number of APA sessions and Fact-Leu	6 months
Evaluate correlation between APA coaching sessions undertaken and fatigue	Correlation between number of APA sessions and Fact-Fa	6 months
Evaluate changes in weight	Change in weight (impedancemetry data via connected weighing machine)	6 months
Evaluate body mass index	Change in body mass index (BMI= Weight/Height²)	6 months
changes in impedancemetry data	Impedaneimetry mesures (connected weighing machine): body mass index variations,	6 months
Evaluate muscle mass	Change in muscle mass (impedancemetry data via connected weighing machine)	6 months
Evaluate fat mass	Abdominal scan by L3 cross-section: Skeletal Muscle Mass Index (SMI= skeletal muscle mass/height)	6 months
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)	6 months
Evaluate adherence to nutrition programme	Number of days enteral and parenteral nutrition	6 months
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	6 months
Complete remision	Complete remision rate	6 months
- Evaluate number of infections documented	number of infections documented	6 months
evaluate number of days of hospitalisation	number of days of hospitalisation mesured in nights	6 months
evaluate rate of early mortality	rate of premature mortality	30 days
evaluate rate of overall mortality	rate of overall mortality	30 days
evaluate cause of overall mortality	cause of premature mortality	6 months
Evaluate rate of non relapse Mortality (RNM)	Rate of NRM	6 months
evaluate overall survival	overal survival rate	6 months
evaluate survival without relapse	survival without relapse rate	6 monts
evaluate survival without events	survival without events rate	6 monts
evaluate number of allotransplant patients	number of allotransplant patients	6 monts
evalaute number of patients disqualified for allotransplant	number of patients with transplant indication disqualified for allotransplant	6 monts
degree of digestive GVH disease	GVH disease grade	6 monts
Evaluation of the severity of digestive GVH disease	severity of GVH desease	6 monts

Collaborators and Investigators

• Sponsor: Institut Paoli-Calmettes
• Investigators: Principal Investigator: Cécile Bannier Braticevic, MD, Institut Paoli-Calmettes

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Estimated): May 4, 2025
• Study Completion (Estimated): May 4, 2025

Study Registration Dates

• First Submitted: July 11, 2018
• First Submitted That Met QC Criteria: July 11, 2018
• First Posted (Actual): July 23, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: physical activity; prehabilitation; coaching; nutritional support; allogeneic stem cells transplantation
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Histologic Type; Disease; Hematologic Diseases; Precancerous Conditions; Bone Marrow Diseases; Syndrome; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Myelodysplastic Syndromes
• Other Study ID Numbers: COHABILIT-IPC 2017-046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No