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

Primary Purpose

Acute Myeloid Leukemia, Myelodysplastic Syndromes

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Coaching and Habilitation
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Myeloid Leukemia focused on measuring prehabilitation, coaching, nutritional support, physical activity, allogeneic stem cells transplantation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institut Paoli CalmettesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prehabilitation program

Arm Description

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

Outcomes

Primary Outcome Measures

feasibility to the adapted multidisciplinary program
proportion of patients who will complete more than 50% of the APA/coaching sessions prescribed

Secondary Outcome Measures

Full Information

First Posted
July 11, 2018
Last Updated
February 13, 2023
Sponsor
Institut Paoli-Calmettes
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1. Study Identification

Unique Protocol Identification Number
NCT03595787
Brief Title
COaching and Prehabilitation: Faisability Study in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 4, 2022 (Actual)
Primary Completion Date
May 4, 2025 (Anticipated)
Study Completion Date
May 4, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Myelodysplastic Syndromes
Keywords
prehabilitation, coaching, nutritional support, physical activity, allogeneic stem cells transplantation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prehabilitation program
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Coaching and Habilitation
Intervention Description
nutritional support, adapted physical activity and coaching
Primary Outcome Measure Information:
Title
feasibility to the adapted multidisciplinary program
Description
proportion of patients who will complete more than 50% of the APA/coaching sessions prescribed
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique Genre, MD
Phone
+33491223778
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jihane Pakradouni, PharmD, PhD
Phone
+33491223778
Email
drci.up@ipc.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cécile Bannier Braticevic, MD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique Genre, MD
Phone
33 (0)4 91 22 37 78
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Jihane Pakradouni, PharmD, PhD
Phone
33 (0)4 91 22 37 78
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Cécile Braticevic, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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