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

Childhood Cancer Clinical Trial

— APADHOP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06230016
• Other study ID #: 2023-A02343-42
• Status: Recruiting
• Start date: February 16, 2024
• Est. completion date: January 31, 2025

Study information

• Verified date: December 2023
• Source: University Hospital, Grenoble
• Contact: Isabelle Schiff, PHD
• Phone: +33476766561
• Email: ISchiff[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: January 31, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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

• 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.)

Related Conditions & MeSH terms

• Adapted Physical Activity
• Childhood Cancer
• Tissue Adhesions

Intervention

Other:
• questionnaires
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
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

Locations

Country	Name	City	State
France	CHU Grenoble Alpes	Grenoble	Isere

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	University Grenoble Alps

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Motivation and restraints	This outcome is measured through a semi directive questionnaire elaborated by the SENS laboratory (Laboratory of physical exercice and social environment, Grenoble, France). It measures attitudes and motivations that have been identified as key factors in behavior change, within the framework of the main health psychology models of behavior change, such as the theory of planned behavior, the health action process approach, or self-determination theory .In order to measure these constructs, tools adapted to children from 8 years old and scientifically validated were identified in the scientific literature and adapted for the APADHOP project.; Children with cancer over 8 years old and one or both parents will answer to questions at the start of the adapted physical activity programm ((APA) and after 4 to 6 months of APA personnalised support.; There is no scoring as this is a descriptive outcome (after been analyzed by a humanities and social sciences researcher)	4 to 6 months
Secondary	Quality of life measure	Quality of life will be measured by international validated PedsQL questionnaires V4.0 (paediatric quality of Life Inventory) according to the age of the patient: For parents of children aged 2-4 years: For parents of children aged 5 to 7; For parents of children aged 8 to 12; For parents of children aged 13 to 18; For children aged 5 to 7; For children aged 8 to 12; For children aged 13 to 18 This questionnaires will be administrated at the start of the adapted physical activity (APA) programm and after 4 to 6 months of personalized APA support.; Each item of the questionnaire is scored between 0 and 4 and the total score of the questionnaire is between 0 an 100. The higher score means a better quality of life.; To be able to measure the score at least 50% of the items must be answered. The results will be analysed only for patients and parents who have answered to the questionnaires at both evaluation time.	4 to 6 months
Secondary	Representation of physical activity	The evaluation of the representation of physical activity Activity of children and parents at diagnosis and after 4 to 6 months of personalized APA support will be performed through a semi directive questionnaire elaborated by the SENS Laboratory (Laboratory of physical exercice and social environment, Grenoble University in France).; The questionnaires will be administred to patients over 8 years and parents at the start of the adapted physical activity (APA) programm and after 4 to 6 months of personalized APA support. The effect of personalized support will also be studied by carrying out pre/post analyzes of these dimensions.; There is no scoring as this is a descriptive outcome that will be analysed by humanities and social siences university researchers.	4 to 6 months