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

Acute Myeloid Leukemia Clinical Trial

— COHABILIT  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03595787
• Other study ID #: COHABILIT-IPC 2017-046
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2022
• Est. completion date: May 4, 2025

Study information

• Verified date: February 2024
• Source: Institut Paoli-Calmettes
• Contact: Dominique Genre, MD
• Phone: +33491223778
• Email: drci.up[@]ipc.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 4, 2025
• Est. primary completion date: May 4, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Procedure:
• Coaching and Habilitation
nutritional support, adapted physical activity and coaching

Locations

Country	Name	City	State
France	Institut Paoli Calmettes	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility to the adapted multidisciplinary program	proportion of patients who will complete more than 50% of the APA/coaching sessions prescribed	6 months
Secondary	Evaluate change in functional capacity	Test SPPB	6 months
Secondary	Evaluate changes in upper limb strengt	Prehension strength with handgrip	6 months
Secondary	Evaluate changes in lower limb strength	Quadriceps strength with dynamometer	6 months
Secondary	Evaluate physical activity sessions modalities	Data from connected watch	6 months
Secondary	Evaluate physical activity sessions feasability	Number of sessions not undertaken and reason for refusal	6 months
Secondary	Evaluate positive and negative affect	Outcomes of questionaries : PANAS,	6 months
Secondary	Evaluate life satisfaction	Outcomes of questionaries LSS	6 months
Secondary	Evaluate the level of depression	Outcomes of questionaries HADS	6 months
Secondary	Evaluate the quality of the trainer-trainee relationship	Outcomes of questionaries CART-Q	6 months
Secondary	Evaluate self-efficacy	Outcomes of questionaries Self-efficacy	6 months
Secondary	Evaluate relationship dynamics	Semi-directive interviews	6 months
Secondary	Evaluate QoL	Outcomes of questionaries FACT-Leu	6 months
Secondary	Evaluate the cancer related fatigue	Outcomes of questionaries FACT-Fa	6 months
Secondary	Evaluate correlation between APA coaching sessions undertaken and NRM	Correlation between number of APA sessions and NRM	6 months
Secondary	Evaluate correlation between APA coaching sessions undertaken and survival	Correlation between number of APA sessions and survival rates	6 months
Secondary	Evaluate correlation between APA coaching sessions undertaken and QoL	Correlation between number of APA sessions and Fact-Leu	6 months
Secondary	Evaluate correlation between APA coaching sessions undertaken and fatigue	Correlation between number of APA sessions and Fact-Fa	6 months
Secondary	Evaluate changes in weight	Change in weight (impedancemetry data via connected weighing machine)	6 months
Secondary	Evaluate body mass index	Change in body mass index (BMI= Weight/Height²)	6 months
Secondary	changes in impedancemetry data	Impedaneimetry mesures (connected weighing machine): body mass index variations,	6 months
Secondary	Evaluate muscle mass	Change in muscle mass (impedancemetry data via connected weighing machine)	6 months
Secondary	Evaluate fat mass	Abdominal scan by L3 cross-section: Skeletal Muscle Mass Index (SMI= skeletal muscle mass/height)	6 months
Secondary	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
Secondary	Evaluate adherence to nutrition programme	Number of days enteral and parenteral nutrition	6 months
Secondary	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
Secondary	Complete remision	Complete remision rate	6 months
Secondary	- Evaluate number of infections documented	number of infections documented	6 months
Secondary	evaluate number of days of hospitalisation	number of days of hospitalisation mesured in nights	6 months
Secondary	evaluate rate of early mortality	rate of premature mortality	30 days
Secondary	evaluate rate of overall mortality	rate of overall mortality	30 days
Secondary	evaluate cause of overall mortality	cause of premature mortality	6 months
Secondary	Evaluate rate of non relapse Mortality (RNM)	Rate of NRM	6 months
Secondary	evaluate overall survival	overal survival rate	6 months
Secondary	evaluate survival without relapse	survival without relapse rate	6 monts
Secondary	evaluate survival without events	survival without events rate	6 monts
Secondary	evaluate number of allotransplant patients	number of allotransplant patients	6 monts
Secondary	evalaute number of patients disqualified for allotransplant	number of patients with transplant indication disqualified for allotransplant	6 monts
Secondary	degree of digestive GVH disease	GVH disease grade	6 monts
Secondary	Evaluation of the severity of digestive GVH disease	severity of GVH desease	6 monts