NCT Number: NCT07621887
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:
1. Is it feasible to conduct a larger randomised controlled trial of the digitalised EFT intervention? 2. 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:
1. Receive a 20-minute educational session on how to use the mobile application 2. Use the mobile application to self-assess their appropriate physical activity level and exercise with a virtual coach 3. Complete questionnaires and wear an accelerometer at 1, 3, and 6 months after enrollment 4. Attend a 20-30-minute individual interview at 6 months (intervention group only, 10 participants)
Trial opening soon.
Get Notified12 year–18 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Participants in the control group will receive usual care with treatment and follow-ups from the hospital.
Time frame: 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.
Time frame: During the recruitment period (up to 6 months)
Calculated by dividing the number of participants who are eligible by the number who are screened.
Time frame: 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.
Time frame: 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.
Time frame: Time Point 1 (at 1 month after intervention)
Calculated by dividing the number of participants who complete the intervention by those who are randomized
Time frame: 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 frame: 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 frame: 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)
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.
Time frame: 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 frame: 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 frame: Time Point 1 (at 1 month after intervention), Time Point 3 (at 6 months after the intervention)
Physical activity (PA) levels assessed via accelerometers.
Time frame: 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.
Time frame: 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.
Time frame: 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
Contact information is provided by the study sponsor or research team.
The Hong Kong Polytechnic University
Other
Digitalised Exercise Fit Tool Intervention for Adolescents With Hematologic Cancer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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