Clinical trial NCT06230016: Adhesion of Children and Adolescents Treated for Cancer to Personalized Support in Adapted Physical Activity Program
Official title: Evaluation of the Adhesion of Children and Adolescents Treated for Cancer to Personalized Support in Adapted Physical Activity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Childhood Cancer
Adapted Physical Activity
Keywords: motivation
restraint
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: University Grenoble Alps
First posted: 2024-01-29
Enrollment: 48
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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

Detailed description: The literature and the French Cancer Plan confirm the benefits of physical activity for cancer patients, and underline the importance of developing appropriate physical activity support for children and adolescents, given their specific needs and the societal and public health challenge represented by these budding patients.

Despite the abundance of studies relating to physical activity in oncology, few data are available, particularly in the pediatric and adolescent/young adult population :

* on physical activity interventions initiated early and sustained over time
* on personalized physical activity interventions integrated into the patient's care/life trajectory
* on factors favoring adhesion to an adapted physical activity program \[APA\] during and/or after cancer treatment

This is a prospective, exploratory, monocentric study to explore these points.

As part of routine management in the immunohaemato-oncology \[IHO\] department of the Grenoble Alpes University Hospital, a personalized physical activity \[PA\] program is systematically proposed by a PA professional, with a program adapted to the child, his or her motivations and limitations.

As part of the protocol, a questionnaire-based assessment of motivations and obstacles, as well as quality of life, will be carried out at the start of the PA program and again after 4 to 6 months. Criteria for adherence to the APA program will also be collected.

EXPECTED OUTPUTS

* Propose an organizational model in pediatric oncology for the early and sustained practice of APA with children and adolescents hospitalized for cancer.
* Finalize assessment and follow-up materials for children receiving APA support in pediatric oncology (information leaflets, certificate of no contra-indication to APA, assessment and follow-up form, questionnaire on attitude and motivation to APA, etc.).
* Provide guidance to help young cancer patients adhere more effectively to APA program.
* Participate in the promotion of APA and the development of APA recommendations for children and adolescents treated for cancer, in conjunction with the SFCE (Children Cancer French Society) national working group on APA for children and adolescents with cancer.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.)

Primary outcomes:
measure: Adhesion to an APA programm
timeFrame: 4 to 6 months
Secondary outcomes:
measure: Motivation and restraints
timeFrame: 4 to 6 months
measure: Quality of life measure
timeFrame: 4 to 6 months
measure: Representation of physical activity
timeFrame: 4 to 6 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble Alpes
state: Isere
Study officials:
affiliation: CHU Grenoble Alpes
name: Leila Gofti Laroche, MD
role: PRINCIPAL_INVESTIGATOR
References: