Digitalized Exercise Fit Tool Intervention for Adolescents With Blood Cancer
2026年7月24日 更新者：Dr Katherine Lam、The Hong Kong Polytechnic University
Digitalised Exercise Fit Tool Intervention for Adolescents With Hematologic Cancer
The goal of this clinical trial is to learn if a digitalised Exercise Fit Tool (EFT) mobile application can promote physical activity in adolescents aged 12-18 years who have completed treatment for hematologic cancer (e.g., leukaemia and lymphoma). The main questions it aims to answer are:
- Is it feasible to conduct a larger randomised controlled trial of the digitalised EFT intervention?
- Does the digitalised EFT intervention improve physical activity levels, physical activity self-efficacy, and quality of life at 6 months?
Researchers will compare the digitalised EFT intervention group to a usual care group to see if the mobile application can promote physical activity levels, physical activity self-efficacy, and quality of life in adolescents with hematologic cancer.Participants will:
- Receive a 20-minute educational session on how to use the mobile application
- Use the mobile application to self-assess their appropriate physical activity level and exercise with a virtual coach
- Complete questionnaires and wear an accelerometer at 1, 3, and 6 months after enrollment
- Attend a 20-30-minute individual interview at 6 months (intervention group only, 10 participants)
研究概览
研究类型
介入性
注册 (估计的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Ka Wai Katherine LAM, Doctor of Philosophy
- 电话号码：+852 27666420
- 邮箱：kw-katherine.lam@polyu.edu.hk
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
- (1) they are 12-18 years old;
- (2) they had been diagnosed with hematologic cancer such as leukaemia and lymphoma;
- (3) they are regarded by the responsible physicians as stable, able to conduct PA, and without any PA restrictions,
- (4) they completed all cancer treatment;
- (5) they speak Cantonese and read Chinese.
Exclusion Criteria:
- (1) Receiving palliative care
- (2) Have physical or cognitive impairment and learning problems as identified from medical records
- (3) Identified by physicians that no physical activity should be conducted at the time of recruitment
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：日常护理
|
Participants in the control group will receive usual care with treatment and follow-ups from the hospital.
|
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实验性的：Digitalised EFT intervention
|
Participants in the intervention group will be delivered a 20-minute educational session to the participants.
During this session, participants will be educated about the introduction and operation of the mobile application.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Screening rate
大体时间：During the recruitment period (up to 6 months)
|
Calculated as the number of participants screened at participating hospital divided by number of participants at participated hospitals during the recruitment period.
|
During the recruitment period (up to 6 months)
|
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Eligibility rate
大体时间：During the recruitment period (up to 6 months)
|
Calculated by dividing the number of participants who are eligible by the number who are screened.
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During the recruitment period (up to 6 months)
|
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Consent rate
大体时间：During the recruitment period (up to 6 months)
|
Calculated by dividing the number of participants who consent to join the study by the number who are eligible.
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During the recruitment period (up to 6 months)
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Randomization rate
大体时间：Time Point 1 (at 1 month after intervention)
|
Calculated by dividing the number of participants who are randomized into intervention and control groups by those who provide consent.
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Time Point 1 (at 1 month after intervention)
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Attendance rate
大体时间：Time Point 1 (at 1 month after intervention)
|
Calculated by dividing the number of participants who complete the intervention by those who are randomized
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Time Point 1 (at 1 month after intervention)
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Retention rate
大体时间：Time Point 3 (at 6 months after intervention)
|
Calculated by dividing the number of participants who remain in the study by those who are randomized.
Retention rates for the intervention and control groups will be calculated at each follow-up.
|
Time Point 3 (at 6 months after intervention)
|
|
Adherence rate
大体时间：Time Point 1 (at 1 month after intervention)
|
Calculated by dividing the number of participants students who follow the intervention protocol by those who are randomized.
|
Time Point 1 (at 1 month after intervention)
|
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Complete rate
大体时间：Time Point 1 (at 1 month after the intervention), Time Point 2 (at 3 month after intervention), Time Point 3 (at 6 months after intervention)
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Calculated by dividing the number of participants who returned questionnaires by the number of questionnaires distributed.
This will be calculated by groups at baseline and each follow-up.
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Time Point 1 (at 1 month after the intervention), Time Point 2 (at 3 month after intervention), Time Point 3 (at 6 months after intervention)
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Proportion of missing data
大体时间：Time Point 3 (at 6 months after the intervention)
|
Calculated as the percentage of missing values in the dataset.
Unknown or blank values will be considered missing values.
|
Time Point 3 (at 6 months after the intervention)
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Adverse events
大体时间：Time Point 3 (at 6 months after the intervention)
|
Adverse events are defined as unfavourable and unintended events that are not present at baseline or appear to have worsened during the study.
|
Time Point 3 (at 6 months after the intervention)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Physical activity (PA) levels
大体时间：Time Point 1 (at 1 month after intervention), Time Point 3 (at 6 months after the intervention)
|
Physical activity (PA) levels assessed via accelerometers.
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Time Point 1 (at 1 month after intervention), Time Point 3 (at 6 months after the intervention)
|
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Physical activity (PA) levels
大体时间：Time Point 1 (at 1 month after the intervention), Time Point 3 (at 6 months after the intervention)
|
Physical activity (PA) levels assessed via self-reports.
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Time Point 1 (at 1 month after the intervention), Time Point 3 (at 6 months after the intervention)
|
|
Physical Activity Self-Efficacy (PASE)
大体时间：Time Point 1 (at 1 month after the intervention), Time Point 3 (at 6 months after the intervention)
|
It comprises five items on a three-point Likert scale, with scores ranging from 5 to 15.
Higher scores indicate higher levels of PASE.
Its psychometric properties have been examined in Chinese adolescents with cancer, with good content validity and test.
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Time Point 1 (at 1 month after the intervention), Time Point 3 (at 6 months after the intervention)
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|
Quality of life (QoL)
大体时间：Time Point 1 (at 1 month after the intervention), Time Point 3 (at 6 months after the intervention)
|
Participants' QoL will be measured using child specific EQ-5D-Y-5L scale, which is validated in ages 8-15 via self-report.
A published algorithm will be used to convert the scores into a single utility score.
Scores range from 0 to 100, with higher scores indicating better QoL
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Time Point 1 (at 1 month after the intervention), Time Point 3 (at 6 months after the intervention)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月20日
初级完成 (估计的)
2027年7月19日
研究完成 (估计的)
2027年12月31日
研究注册日期
首次提交
2026年5月19日
首先提交符合 QC 标准的
2026年6月1日
首次发布 (实际的)
2026年6月2日
研究记录更新
最后更新发布 (实际的)
2026年7月27日
上次提交的符合 QC 标准的更新
2026年7月24日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.