Adhesion of Children and Adolescents Treated for Cancer to Personalized Support in Adapted Physical Activity Program

NCT06230016 | Unknown

• 1 other identifier: 2023-A02343-42
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Adapted physical activity session with a formed professional is proposed in standard care since 2022 in the immuno-hematological service to all children with newly diagnosed cancer or relapse. The aim of this study is to keep the children in the APA programm during all the treatment lenght. This study aims to evaluate by questionnaires the motivation keys and restraint from children and parents before the APA program starts (at diagnosis or relapse if not previously participating to an APA programm) and after 4 to 6 months of APA programm. The final expected fallout is to enhance children adhesion to long term APA program by implementing tools in current practice to overcome restraints from young patients and their parents

Conditions

Childhood Cancer; Adapted Physical Activity

Keywords

motivation; restraint

Outcome Measures

Primary Outcomes (1)

• Adhesion to an APA programm

  Adherence of children and adolescents undergoing cancer treatment to personalized support in Adapted Physical Activity \[APA\] offered at an early stage and for a minimum duration of 4 to 6 months : patients following the whole APA program/patients included, in percent

  4 to 6 months

Secondary Outcomes (3)

• Motivation and restraints

  4 to 6 months

• Quality of life measure

  4 to 6 months

• Representation of physical activity

  4 to 6 months

Interventions

questionnaires OTHER

human and social science questionnaire (specifically designed by the expert lab of Grenoble) on motivation and restraint perceived by patient and parents, elaborated especially for this study. Questionnaire administred before the start of current care APA programm and after 4 to 6 months.

PedsQL quality of life questionnaires OTHER

validated PedsQL (The Pediatric Quality of Life Inventory) questionnaires administred to children (if adequate) and parents before the start of current care APA programm and after 4 to 6 months

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with cancer taken in charge in the paediatric immuno haematology service of the Grenoble Alpes University Hospital

You may qualify if:

• Patients aged 3 years to under 18 years under care at Grenoble Alpes University Hospital
• New cancer diagnosis or relapse in the absence of previous APA treatment
• All cancer pathologies:
• Diagnosis of acute or chronic hematological malignancy OR Central nervous system tumors OR Other solid tumors
• Regardless of therapeutic pathway
• Parents and patient over 5 years old understanding french langage
• Patient and parents who have not objected to participation after being informed

You may not qualify if:

• Patient with a strict medical contraindication to physical activity identified by the referring physician or another specialist physician, particularly the sports physician (unstabilized heart or lung disease, uncontrolled diabetes, etc.)

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• University Grenoble Alps: collaborator

Study Sites (1)

CHU Grenoble Alpes

Grenoble, Isere, 38000, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Leila Gofti Laroche, MD

  CHU Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle Schiff, PHD

CONTACT

+33476766561; ISchiff@chu-grenoble.fr

Laura Chambon

CONTACT

33 4 76 76 89 35; lchambon@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 29, 2024
• Study Start: February 16, 2024
• Primary Completion: August 16, 2025
• Study Completion: January 31, 2026
• Last Updated: September 23, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)