LeukemiaNCT04136665
Physical Activity Adapted at Home Supervised by Videoconferencing in Post-cancer for Children / AYA Treated for Leukemia (ONCOPED SAPATIC)
A study testing Physical Activity Adapted program in people with Leukemia, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Leukemia
- What is being tested?
- Physical Activity Adapted program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 14 Dec 2019to 6 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Contraindication to the practice of an APA program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Activity Adapted at Home Supervised by Videoconferencing in Post-cancer for Children / AYA Treated for Leukemia: Reduction of Territorial and Social Inequalities Due to E-health - Feasibility Study (ONCOPED SAPATIC)
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.
Read the detailed description
Leukemia is the most common form of cancer (29%) in children, adolescents, and young adults (AYA). 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. However, some publications show clearly the benefits of an APA program for this population. It is important to note that these studies (and therefore the evaluated APA programs) were carried out during hospitalization, where a significant sedentary situation was reported in children/AYA with cancer, especially on their return home. The main barriers to the practice of APA, recently described in the literature, are: 1 / Patient's distance from the health center (geographical and social inequality); 2 / Insufficient involvement of the family environment (social inequality); 3 / Social rupture of the child / AYA. To neutralize these particularly marked inequalities in post-cancer period, the introduction of a home-based APA program represents an innovative and relevant solution. Thus, it was reported that 91% (out of 1500 participants) of children / AYAs with cancer wish to engage in physical activity at home regardless the time of the care course. In addition, the use of new information and communication technologies (ICT) such as videoconferencing does not constitute a barrier to the practice of APA for this young population familiar with connected tools. The practice of APA could even be an important lever in the fight against sedentary lifestyle by inducing a long-term change in behavior. In order to achieve these objectives, the APA programs in children/AYA with cancer should meet 3 major criteria: 1 / Professionally supervised sessions; 2 / Progressive increase in number and intensity of sessions; 3 / Accompanying the patient to an independent practice of regular physical activity. To date, the studies reported in literature have proposed "APA follow-ups" at home only by mail, telephone or via internet applications. Their effects appear limited on physical capacities for children/AYAs with cancer. However, according to these authors, setting up a home-based APA program through the use of ICTs would maximize the benefits on the physical capabilities and quality of life of all these patients. To the investigator's knowledge, no study has yet been conducted to evaluate the feasibility of such a program, and its consequences on patients.
- Conditions
- Leukemia
- Being tested
- Physical Activity Adapted program
- Keywords
- children, leukemia, physical activity adapted
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity Adapted programOther
6-month APA home program, supervised by videoconferencing in post-cancer for children / AYA treated for leukemia
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Adapted program | Experimental | Not described Receives: Other: Physical Activity Adapted program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (4)
evaluate the impact of a 6-month APA home program on the muscle strength of lower limbs
Assessment of the muscle strength of lower limbs by the 30s chair test at the beginning and at the end of the APA home program
Measured: 6 months
evaluate the impact of a 6-month APA home program on the exercise capacity
Assessment of the exercise capacity by the six minutes walk test at the beginning and the end of the study
Measured: 6 months
evaluate the impact of a 6-month APA home program on the muscle flexibility
Assessment of the muscle flexibility by the sit and reach test at the beginning and the end of the study
Measured: 6 months
evaluate the impact of a 6-month APA home program on the quality of life: PedsQL
Assessment of the quality of life by the PedsQL at the beginning and the end of study
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start14 Dec 2019
- Primary completion6 Sep 2022
- Study completion6 Sep 2022
Why it stopped: Not enough patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- mooven society
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136665
- Sponsor's protocol ID
- RECHMPL19_0181
- Status last verified
- Jan 2022
- First submitted
- 18 Oct 2019
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Adapted at Home Supervised by Videoconferencing in Post-cancer for Children / AYA Treated for Leukemia: Reduction of Territorial and Social Inequalities Due to E-health - Feasibility Study (ONCOPED SAPATIC)
- ClinicalTrials.gov ID
- NCT04136665
- Acronym / sponsor ID
- RECHMPL19_0181
- Conditions
- Leukemia
- Keywords
- children, leukemia, physical activity adapted
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough patient
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- mooven society
- Study start
- 14 Dec 2019 (actual)
- Primary completion
- 6 Sep 2022 (actual)
- Study completion
- 6 Sep 2022 (actual)
- First posted
- 23 Oct 2019 (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.
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.
Detailed description
Leukemia is the most common form of cancer (29%) in children, adolescents, and young adults (AYA). 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. However, some publications show clearly the benefits of an APA program for this population. It is important to note that these studies (and therefore the evaluated APA programs) were carried out during hospitalization, where a significant sedentary situation was reported in children/AYA with cancer, especially on their return home. The main barriers to the practice of APA, recently described in the literature, are: 1 / Patient's distance from the health center (geographical and social inequality); 2 / Insufficient involvement of the family environment (social inequality); 3 / Social rupture of the child / AYA. To neutralize these particularly marked inequalities in post-cancer period, the introduction of a home-based APA program represents an innovative and relevant solution. Thus, it was reported that 91% (out of 1500 participants) of children / AYAs with cancer wish to engage in physical activity at home regardless the time of the care course. In addition, the use of new information and communication technologies (ICT) such as videoconferencing does not constitute a barrier to the practice of APA for this young population familiar with connected tools. The practice of APA could even be an important lever in the fight against sedentary lifestyle by inducing a long-term change in behavior. In order to achieve these objectives, the APA programs in children/AYA with cancer should meet 3 major criteria: 1 / Professionally supervised sessions; 2 / Progressive increase in number and intensity of sessions; 3 / Accompanying the patient to an independent practice of regular physical activity. To date, the studies reported in literature have proposed "APA follow-ups" at home only by mail, telephone or via internet applications. Their effects appear limited on physical capacities for children/AYAs with cancer. However, according to these authors, setting up a home-based APA program through the use of ICTs would maximize the benefits on the physical capabilities and quality of life of all these patients. To the investigator's knowledge, no study has yet been conducted to evaluate the feasibility of such a program, and its consequences on patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Adapted program | Experimental | Other: Physical Activity Adapted program |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Contraindication to the practice of an APA program.
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 |
|---|---|---|
| Physical Activity Adapted program6-month APA home program, supervised by videoconferencing in post-cancer for children / AYA treated for leukemia | Other | Physical Activity Adapted program |
Primary outcome
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
Time frame: 6 months
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
4 secondary outcomes
evaluate the impact of a 6-month APA home program on the muscle strength of lower limbs
Time frame: 6 months
evaluate the impact of a 6-month APA home program on the exercise capacity
Time frame: 6 months
evaluate the impact of a 6-month APA home program on the muscle flexibility
Time frame: 6 months
evaluate the impact of a 6-month APA home program on the quality of life: PedsQL
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Not enough patient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Adapted program in people with Leukemia, run by University Hospital, Montpellier 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 3 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: stopped early, as of the sponsor's last update on 22 Dec 2022. 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?
The study was stopped early (reason given: Not enough patient). Results are not available in the source record.
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?
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 (time frame: 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 22 Dec 2022.