NCT04136665

Brief Summary

Leukemia is the most common form of cancer (29%) in children, adolescents, and young adults (AYA) (CNIB Report, 2017). Current treatments for leukemia (conventional chemotherapy or hematopoietic stem cell transplantation) can lead to significant side effects, acute or chronic, which can lead to impaired physical abilities and reduced quality of life for patients in short, medium or long term. For children and AYA with cancer, adapted physical activity (APA) is now recommended even if the scientific evidence of its benefit is still insufficient.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable leukemia

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
terminated

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

October 18, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 23, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

December 14, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2022

Completed
Last Updated

December 22, 2022

Status Verified

January 1, 2022

Enrollment Period

2.7 years

First QC Date

October 18, 2019

Last Update Submit

December 21, 2022

Conditions

Keywords

childrenleukemiaphysical activity adapted

Outcome Measures

Primary Outcomes (1)

  • evaluate the feasibility of a 6-month APA home program, supervised by videoconferencing in post-cancer for children / AYA treated for leukemia: number of completed session / number of theorical session

    Assessment of the feasibility of a 6-month APA home program, supervised by videoconferencing in post-cancer for children / AYA treated for leukemia : number of completed session / number of theorical session

    6 months

Secondary Outcomes (4)

  • evaluate the impact of a 6-month APA home program on the muscle strength of lower limbs

    6 months

  • evaluate the impact of a 6-month APA home program on the exercise capacity

    6 months

  • evaluate the impact of a 6-month APA home program on the muscle flexibility

    6 months

  • evaluate the impact of a 6-month APA home program on the quality of life: PedsQL

    6 months

Study Arms (1)

Physical Activity Adapted program

EXPERIMENTAL
Other: Physical Activity Adapted program

Interventions

6-month APA home program, supervised by videoconferencing in post-cancer for children / AYA treated for leukemia

Physical Activity Adapted program

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patient with Leukemia and followed in intensive post-treatment or with lymphoma and followed in post autologous graft, patient aged 12 to 25 years old (child/AYA), included in the CHU Montpellier and identified by the mobile support team AYA Occitanie-Est, and or the Occitanie-Est Pediatric Division of the Oncology Network of the Occitanie Region,
  • Having completed and signed a consent form for the study (Signature of consent by the parents if the patient is a minor)
  • affiliated to a safety social regime

You may not qualify if:

  • Contraindication to the practice of an APA program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Design

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

Study Record Dates

First Submitted

October 18, 2019

First Posted

October 23, 2019

Study Start

December 14, 2019

Primary Completion

September 6, 2022

Study Completion

September 6, 2022

Last Updated

December 22, 2022

Record last verified: 2022-01

Locations