Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
440 participants
INTERVENTIONAL
2020-08-14
2023-07-31
Brief Summary
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Detailed Description
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1. The aim for Year 1 is as follows:
Aim 1: To explore parents' experience of caring for promoting a child's exercise among parents of children and adolescents with cancer.
2. The aims for Year 2 are as follows:
Aim 2-1: To examine the associations between the degree of muscle wasting and health-related variables (fatigue level, symptom distress level, physical activity involvement, dietary intake, and QoL) among children and adolescents with cancer.
Aim 2-2: To examine the trends of changes in muscle wasting and health-related variables (fatigue level, symptom distress level, physical activity involvement, dietary intake, and QoL) during the first 6 months of cancer treatment among children and adolescents with cancer.
3. The aim for Year 3 is as follows:
Aim 3: To examine the effectiveness of a multidisciplinary approach with a personalized walking exercise program on changes in body composition and health-related variables (fatigue level, symptom distress level, subjective physical activity involvement, objective physical activity measurement, dietary intake, and QoL) among children and adolescents with cancer.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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control group
The patients in the control group will not receive any walking exercise education until the 4-week intervention ends. They will then receive the same education material ("How walking is beneficial to your health") and will be told about the benefits of walking.
No interventions assigned to this group
experimental group
Participants in the experimental group will also be educated on the general use of the ActiGraph through verbal and written information and will be asked to wear the ActiGraph during week 0 for 3 consecutive days. The collected physical activity parameters will be the baseline data.Afterward, participants in the experimental group will be educated with the educational materials "How walking is beneficial to muscle mass and your health." And then the ActiGraph will be collected by the research assistant in order to analyze the physical activity parameters, including time spent walking and walking steps. A final assessment will be conducted at week 4. The participant will be reminded that the ActiGraph and the post-test questionnaires will be picked up at the end of week 4.
Multidisciplinary care with a personalized care
During the 4-week intervention, participants will be given stickers by the research assistant to increase their motivation to walk. A sticker will be given once a participant reaches a daily walking-time goal. The number of stickers participants receive depends on the number of days they reach their daily goals. The stickers can be redeemed for the participant's choice of gift in the gift shelf of the ward or on a gift card. A final assessment will be conducted at week 4. The participant will be reminded that the ActiGraph and the post-test questionnaires will be picked up at the end of week 4
Interventions
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Multidisciplinary care with a personalized care
During the 4-week intervention, participants will be given stickers by the research assistant to increase their motivation to walk. A sticker will be given once a participant reaches a daily walking-time goal. The number of stickers participants receive depends on the number of days they reach their daily goals. The stickers can be redeemed for the participant's choice of gift in the gift shelf of the ward or on a gift card. A final assessment will be conducted at week 4. The participant will be reminded that the ActiGraph and the post-test questionnaires will be picked up at the end of week 4
Eligibility Criteria
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Inclusion Criteria
* Aim 2-1:(1) children and adolescents diagnosed with malignancies at 3-18 years old, (2) who are previously or currently treated for cancer, and (3) who are willing to participate in the study. Two hundred patients will be recruited.
* Aim 2-2:(1) children and adolescents diagnosed with malignancies at 3-18 years old, (2) newly diagnosed with cancer within the past 1 month, and (3) willing to participate in the study. One hundred participants will be recruited.
* Aim 3:(1) children and adolescents aged 3-18 years old and are undergoing treatment, and (2) who are willing to participate in the study.
Exclusion Criteria
3 Years
18 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Wei-Wen Wu, PhD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University, College of Medicine
Locations
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NTUH
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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202001023RINA
Identifier Type: -
Identifier Source: org_study_id
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