Childhood CancerAPADHOPNCT06230016
Adhesion of Children and Adolescents Treated for Cancer to Personalized Support in Adapted Physical Activity Program
An observational study of Childhood Cancer and Adapted Physical Activity, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Childhood Cancer, Adapted Physical Activity
- What is being tested?
- questionnaires and PedsQL quality of life questionnaires
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 16 Feb 2024to 31 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with cancer taken in charge in the paediatric immuno haematology service of the Grenoble Alpes University Hospital
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Adhesion of Children and Adolescents Treated for Cancer to Personalized Support in Adapted Physical Activity
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.
Read more
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
Read the 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.
- Conditions
- Childhood Cancer, Adapted Physical Activity
- Being tested
- questionnaires, PedsQL quality of life questionnaires
- Keywords
- motivation, restraint
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
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 questionnairesOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 to 6 months
Secondary outcomes (3)
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)
Measured: 4 to 6 months
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.
Measured: 4 to 6 months
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.
Measured: 4 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start16 Feb 2024
- Primary completion27 Feb 2026
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- University Grenoble Alps
- Responsible party
- Sponsor
- Investigators
- Leila Gofti Laroche, MD, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230016
- Sponsor's protocol ID
- 2023-A02343-42
- Acronym
- APADHOP
- Status last verified
- May 2026
- First submitted
- 26 Dec 2023
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data sharing
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Adhesion of Children and Adolescents Treated for Cancer to Personalized Support in Adapted Physical Activity
- ClinicalTrials.gov ID
- NCT06230016
- Acronym / sponsor ID
- APADHOP / 2023-A02343-42
- Conditions
- Childhood Cancer, Adapted Physical Activity
- Keywords
- motivation, restraint
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- University Grenoble Alps
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with cancer taken in charge in the paediatric immuno haematology service of the Grenoble Alpes University Hospital
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaireshuman 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. | Other | – |
| PedsQL quality of life questionnairesvalidated 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 | Other | – |
Primary outcome
Adhesion to an APA programm
Time frame: 4 to 6 months
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
3 secondary outcomes
Motivation and restraints
Time frame: 4 to 6 months
Quality of life measure
Time frame: 4 to 6 months
Representation of physical activity
Time frame: 4 to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No. No individual participant data sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leila Gofti Laroche, MD principal investigator
CHU Grenoble Alpes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Cancer and Adapted Physical Activity, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adhesion to an APA programm (time frame: 4 to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.