NCT03595787

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 23, 2018

Completed
3.7 years until next milestone

Study Start

First participant enrolled

April 4, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2025

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

3.1 years

First QC Date

July 11, 2018

Last Update Submit

December 13, 2024

Conditions

Acute Myeloid LeukemiaMyelodysplastic Syndromes

Keywords

prehabilitationcoachingnutritional supportphysical activityallogeneic stem cells transplantation

Outcome Measures

Primary Outcomes (1)

  • feasibility to the adapted multidisciplinary program

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

    6 months

Secondary Outcomes (39)

  • Evaluate change in functional capacity

    6 months

  • Evaluate changes in upper limb strengt

    6 months

  • Evaluate changes in lower limb strength

    6 months

  • Evaluate physical activity sessions modalities

    6 months

  • Evaluate physical activity sessions feasability

    6 months

  • +34 more secondary outcomes

Study Arms (1)

Prehabilitation program

EXPERIMENTAL

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

Coaching and HabilitationPROCEDURE

nutritional support, adapted physical activity and coaching

Prehabilitation program

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Paoli Calmettes

Marseille, 13009, France

Location

Related Publications (1)

  • Saillard C, Cuvelier S, Villaron-Goetgheluck C, Boher JM, Almeida-Lopez L, Le Corroller AG, Denis P, Rivieccio C, Calvin S, Vey N, Bannier-Braticevic C. Tripartite prehabilitation of patients with acute myeloid leukaemia and high-risk myelodysplastic syndromes during intensive chemotherapy before allogeneic haematopoietic stem cell transplantation (COHABILIT): protocol for an innovating prospective multicentre study. BMJ Open. 2024 Mar 29;14(3):e076321. doi: 10.1136/bmjopen-2023-076321.

    PMID: 38553062DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic SyndromesMotor Activity

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow DiseasesBehavior

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Cécile Bannier Braticevic, MD

    Institut Paoli-Calmettes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2018

First Posted

July 23, 2018

Study Start

April 4, 2022

Primary Completion

May 4, 2025

Study Completion

May 4, 2025

Last Updated

December 18, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)