Childhood CancerNCT06476951
The Effects of Parent-Child Activity Program on PA of Children With Cancer
A study testing Parent-Child Physical Activity Program in people with Childhood Cancer and Physical Activity, run by Ke Liu at 1 site in China.
Trial summary
The goal of this clinical trial is to test the effect of Parent-Child activity program on physical activity of children with cancer. The main question it aims to answer is: Whether the Parent-Child activity program has effectiveness for children with cancer on their physical Activity, Physical Activity Self-Efficacy… Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Childhood Cancer, Physical Activity, Intervention Program
- What is being tested?
- Parent-Child Physical Activity Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 31 Dec 2025
- 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 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- aged 6-14 years when they are recruited
- diagnosed with cancer
- are undergoing cancer treatment when they are recruited
- are able to communicate in Chinese
- are able to communicate in Chinese and read Chinese
- are able to use a smart phone with the instant messaging application WeChat
Who cannot join
- have physical impairment
- have cognitive impairment
- have impaired mental status
- have emotional or psychiatric disorders
- have cognitive problems
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Yijie Dong, Bachelor, 86 13592034212, dongyj35@mail2.sysu.edu.cn
About this study
Official title: The Effects of Parent-Child Activity Program on Physical Activity of Children With Cancer
The goal of this clinical trial is to test the effect of Parent-Child activity program on physical activity of children with cancer. The main question it aims to answer is:
- Whether the Parent-Child activity program has effectiveness for children with cancer on their physical Activity, Physical Activity Self-Efficacy, Physical Activity Enjoyment, Family Support, and for parents on Physical Activity based on the Youth Physical Activity Promotion Model.
Read more
Participants will:
- Receive a handbook on information related to physical activity and Parent-Child physical activity when the child is undergoing treatment.
- Participate in Parent-Child activities, such as throw ball catch game, which are organized by the professionals.
- Parents or/and children receive subscriptions on physical activity through WeChat, including the benefits of physical activities and Parent-Child activities, common physical activities and Parent-Child activities, and follow-up video.
Researchers will compare control group to see if there are differences between usual care on physical activity and Parent-Child activity program
Read the detailed description
The intervention includes three main contents:
- Establishment and use of WeChat group - information support Nurses in the intervention group establish a WeChat group and invite children with cancer and/or their parents to join the WeChat group, and the children and their parents were regularly subscribed the knowledge related to physical activity on a weekly basis. The contents mainly include the following modules: ① the benefits and importance of physical activity for patients with cancer and the harm of sedentary activities; ② the expert advice and guidelines on physical activity for patients with cancer; ③ common types of physical activities for children with cancer; ④ the suitable amount, frequency and intensity of physical activities for children with cancer; ⑤ the important role of the parents in their children's physical activities and the significance of parent-child activities; ⑥ the measures to ensure the safety of the children during the course of their physical activities; ⑦ emergency treatment plan for any uncomfortable symptoms. In addition, every Monday morning at 8 a.m., the researcher sent a physical activity record list to them, inviting children and parents to record the physical activity accordingly, in order to calculate the amount of exercise per week.
- Use of WeChat Official account - information and skills support Using the WeChat Official account of the hospital's Department of Paediatric Oncology, tweets and video content related to physical activity are published every Thursday, Saturday and Sunday, mainly including knowledge of physical activity and videos on common types of physical activity and parent-child physical activity. Demonstrations and follow-up exercises videos are provided so that children and parents can choose suitable physical activities for exercise according to their own physical conditions and preferences. Among them, the knowledge of the benefits of physical activity, the importance and significance of parent-child activities and how to ensure safety during exercise; physical activity videos include: ① common warm-up and stretching exercises and action points; ② common aerobic exercises (such as brisk walking, jogging, cycling, jumping rope, aerobics, etc.) and action points; ③ common resistance exercises (such as sit-ups, push-ups, high leg lifts, dumbbell exercises, etc.) and action points; ③ common resistance exercises (such as sit-ups, push-ups, high leg lifts, dumbbell exercises, etc.) and action points. (e.g. sit-ups, push-ups, elevated leg exercises, dumbbell exercises, etc.) and the main points of the movements; (4) common parent-child activities (e.g. relay running, two-person aerobics, two-person games, ball games, swinging sports, jumping grids, throwing sandbags, jumping hoops, etc.) and the main points of the movements; (5) common outdoor family sports (e.g. mountain climbing, rowing, etc.) and the strategies and precautions.
- Face-to-face parent-child group activities - venue support The children and their parents were told to follow up for every 4 weeks, and on the day of their return to the hospital for review, 5-7 pairs of children and their parents from the review were organised to participate in face-to-face parent-child group activities together for 90-120 minutes each time. The researcher provided them with venues and sports items (e.g., jump ropes, batons, elastic bands, sports videos, etc.), and organised them to participate in parent-child activities and competitions by using open, flat and safe venues in the hospital. The main contents of the group parent-child activities included: ① warm-up and stretching activities (following the demonstration exercises); ② parent-child games and competitions: such as jumping lattice, relay running, wooden man, throwing sandbags, badminton, ball-carrying running, tug-of-war, etc.; and③parent-child dance demonstration and evaluation.
The intervention will last for 12 weeks, and followed up will be organized for 3 months after the completion of all interventions.
- Being tested
- Parent-Child Physical Activity Program
- Keywords
- Childhood Cancer, Physical Activity, Parent-Child Activity Program
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-Child Physical Activity ProgramBehavioural
The program includes online education, parent-child games, parent-child dancing, and other parent-child physical activity activities.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | No specific care in physical activity |
| Parent-Child Physical Activity Program | Experimental | Parent-Child Physical Activity Program Receives: Behavioral: Parent-Child Physical Activity Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Leisure Activities Study Survey Chinese
To calculate the time that children spend in sedentary behavior, low-intensity physical activity, and moderate-to-vigorous physical activity in last seven days.
Measured: At baseline, and 1, 2, 3 months during the intervention, and 3 months after intervention
Secondary outcomes (9)
International Physical Activity Questionnaire
To calculate the time that parents spend in sedentary behavior, low-intensity physical activity, and moderate-to-vigorous physical activity in last seven days.
Measured: At baseline, and 1, 2, 3 months during the intervention, and 3 months after intervention
Shortened Chinese Version Physical Activity Self-efficacy Scale
To measure the physical activity self-efficacy of children with cancer. Higher scores mean a better outcome.
Measured: At baseline, and 1, 2, 3 months during the intervention, and 3 months after intervention
Short-form Physical Activity Enjoyment Scale
To measure the enjoyment of physical activity in children with cancer. Higher scores mean a worse outcome.
Measured: At baseline, and 1, 2, 3 months during the intervention, and 3 months after intervention
the Social Support for Physical Activity Scale
To measure the perceived family support of physical activity in children with cancer. Higher scores mean a better outcome.
Measured: At baseline, 3 months during the intervention, and 3 months after intervention
Body mass index (BMI)
Weight in kilograms, height in meters and weight and height will be combined to report BMI in kg/m^2
Measured: At baseline, 3 months during the intervention, and 3 months after intervention
Body fat mass
Weight of body fat mass in kilograms
Measured: At baseline, 3 months during the intervention, and 3 months after intervention
Muscle
Weight of muscle mass in kilograms
Measured: At baseline, 3 months during the intervention, and 3 months after intervention
Body fat percentage
Body fat percentage in percentage
Measured: At baseline, 3 months during the intervention, and 3 months after intervention
Muscle percentage
Muscle percentage in percentage
Measured: At baseline, 3 months during the intervention, and 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start1 Sep 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (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.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ke Liu
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, National Natural Science Foundation of China
- Responsible party
- Sponsor-investigator, Ke Liu, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476951
- Sponsor's protocol ID
- L2023SYSU-HL-020
- Other IDs
- SYSKY-2024-148-02
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Parent-Child Activity Program on Physical Activity of Children With Cancer
- ClinicalTrials.gov ID
- NCT06476951
- Acronym / sponsor ID
- L2023SYSU-HL-020
- Keywords
- Childhood Cancer, Physical Activity, Parent-Child Activity Program
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Ke LiuUniversity, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, National Natural Science Foundation of China
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Jun 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.
The goal of this clinical trial is to test the effect of Parent-Child activity program on physical activity of children with cancer. The main question it aims to answer is:
- Whether the Parent-Child activity program has effectiveness for children with cancer on their physical Activity, Physical Activity Self-Efficacy, Physical Activity Enjoyment, Family Support, and for parents on Physical Activity based on the Youth Physical Activity Promotion Model.
Participants will:
- Receive a handbook on information related to physical activity and Parent-Child physical activity when the child is undergoing treatment.
- Participate in Parent-Child activities, such as throw ball catch game, which are organized by the professionals.
- Parents or/and children receive subscriptions on physical activity through WeChat, including the benefits of physical activities and Parent-Child activities, common physical activities and Parent-Child activities, and follow-up video.
Researchers will compare control group to see if there are differences between usual care on physical activity and Parent-Child activity program
Detailed description
The intervention includes three main contents:
- Establishment and use of WeChat group - information support Nurses in the intervention group establish a WeChat group and invite children with cancer and/or their parents to join the WeChat group, and the children and their parents were regularly subscribed the knowledge related to physical activity on a weekly basis. The contents mainly include the following modules: ① the benefits and importance of physical activity for patients with cancer and the harm of sedentary activities; ② the expert advice and guidelines on physical activity for patients with cancer; ③ common types of physical activities for children with cancer; ④ the suitable amount, frequency and intensity of physical activities for children with cancer; ⑤ the important role of the parents in their children's physical activities and the significance of parent-child activities; ⑥ the measures to ensure the safety of the children during the course of their physical activities; ⑦ emergency treatment plan for any uncomfortable symptoms. In addition, every Monday morning at 8 a.m., the researcher sent a physical activity record list to them, inviting children and parents to record the physical activity accordingly, in order to calculate the amount of exercise per week.
- Use of WeChat Official account - information and skills support Using the WeChat Official account of the hospital's Department of Paediatric Oncology, tweets and video content related to physical activity are published every Thursday, Saturday and Sunday, mainly including knowledge of physical activity and videos on common types of physical activity and parent-child physical activity. Demonstrations and follow-up exercises videos are provided so that children and parents can choose suitable physical activities for exercise according to their own physical conditions and preferences. Among them, the knowledge of the benefits of physical activity, the importance and significance of parent-child activities and how to ensure safety during exercise; physical activity videos include: ① common warm-up and stretching exercises and action points; ② common aerobic exercises (such as brisk walking, jogging, cycling, jumping rope, aerobics, etc.) and action points; ③ common resistance exercises (such as sit-ups, push-ups, high leg lifts, dumbbell exercises, etc.) and action points; ③ common resistance exercises (such as sit-ups, push-ups, high leg lifts, dumbbell exercises, etc.) and action points. (e.g. sit-ups, push-ups, elevated leg exercises, dumbbell exercises, etc.) and the main points of the movements; (4) common parent-child activities (e.g. relay running, two-person aerobics, two-person games, ball games, swinging sports, jumping grids, throwing sandbags, jumping hoops, etc.) and the main points of the movements; (5) common outdoor family sports (e.g. mountain climbing, rowing, etc.) and the strategies and precautions.
- Face-to-face parent-child group activities - venue support The children and their parents were told to follow up for every 4 weeks, and on the day of their return to the hospital for review, 5-7 pairs of children and their parents from the review were organised to participate in face-to-face parent-child group activities together for 90-120 minutes each time. The researcher provided them with venues and sports items (e.g., jump ropes, batons, elastic bands, sports videos, etc.), and organised them to participate in parent-child activities and competitions by using open, flat and safe venues in the hospital. The main contents of the group parent-child activities included: ① warm-up and stretching activities (following the demonstration exercises); ② parent-child games and competitions: such as jumping lattice, relay running, wooden man, throwing sandbags, badminton, ball-carrying running, tug-of-war, etc.; and③parent-child dance demonstration and evaluation.
The intervention will last for 12 weeks, and followed up will be organized for 3 months after the completion of all interventions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –No specific care in physical activity |
| Parent-Child Physical Activity Program | Experimental | Behavioral: Parent-Child Physical Activity ProgramParent-Child Physical Activity Program |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- aged 6-14 years when they are recruited
- diagnosed with cancer
- are undergoing cancer treatment when they are recruited
- are able to communicate in Chinese
- are able to communicate in Chinese and read Chinese
Key exclusion criteria (5 listed)
- have physical impairment
- have cognitive impairment
- have impaired mental status
- have emotional or psychiatric disorders
- have cognitive problems
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 |
|---|---|---|
| Parent-Child Physical Activity ProgramThe program includes online education, parent-child games, parent-child dancing, and other parent-child physical activity activities. | Behavioural | Parent-Child Physical Activity Program |
Primary outcome
Children's Leisure Activities Study Survey Chinese
Time frame: At baseline, and 1, 2, 3 months during the intervention, and 3 months after intervention
To calculate the time that children spend in sedentary behavior, low-intensity physical activity, and moderate-to-vigorous physical activity in last seven days.
9 secondary outcomes
International Physical Activity Questionnaire
Time frame: At baseline, and 1, 2, 3 months during the intervention, and 3 months after intervention
Shortened Chinese Version Physical Activity Self-efficacy Scale
Time frame: At baseline, and 1, 2, 3 months during the intervention, and 3 months after intervention
Short-form Physical Activity Enjoyment Scale
Time frame: At baseline, and 1, 2, 3 months during the intervention, and 3 months after intervention
the Social Support for Physical Activity Scale
Time frame: At baseline, 3 months during the intervention, and 3 months after intervention
Body mass index (BMI)
Time frame: At baseline, 3 months during the intervention, and 3 months after intervention
Body fat mass
Time frame: At baseline, 3 months during the intervention, and 3 months after intervention
Muscle
Time frame: At baseline, 3 months during the intervention, and 3 months after intervention
Body fat percentage
Time frame: At baseline, 3 months during the intervention, and 3 months after intervention
Muscle percentage
Time frame: At baseline, 3 months during the intervention, and 3 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Childhood Cancer
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingObservational study
Psychological Benefits of a Normalized Camping Experience for Children With Cancer
Pediatric Cancer
Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
RecruitingObservational study
The Decision To Enroll In Therapeutic Clinical Trials In A Pediatric Cancer Clinical Network
Knowledge, Attitudes, Practice
Recruiting
Facial Expression Awareness Training to Understand and Recognize Emotions
Survivors of Pediatric Brain Tumors, Pediatric Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-Child Physical Activity Program in people with Childhood Cancer and Physical Activity, run by Ke Liu at 1 site in China.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Jun 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yijie Dong, Bachelor (86 13592034212, dongyj35@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Leisure Activities Study Survey Chinese (time frame: At baseline, and 1, 2, 3 months during the intervention, and 3 months after intervention). 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 27 Jun 2024.