Digitalized Exercise Fit Tool Intervention for Adolescents With Blood Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorThe Hong Kong Polytechnic University
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
(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;
Disqualifiers
(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
Trial design
Design model
Parallel
Treatments tested in this trial
Digitalized Exercise Fit Tool Intervention
BehavioralParticipants 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.
Usual Care
BehavioralParticipants in the control group will receive usual care with treatment and follow-ups from the hospital.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Digitalised EFT interventionExperimental treatment 1 intervention
Group B: usual carePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Screening rate
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)2
Eligibility rate
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)3
Consent rate
Calculated by dividing the number of participants who consent to join the study by the number who are eligible.
Time frame
During the recruitment period (up to 6 months)4
Randomization rate
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)Secondary outcomes
1
Physical activity (PA) levels
Physical activity (PA) levels assessed via accelerometers.
Time frame
Time Point 1 (at 1 month after intervention), Time Point 3 (at 6 months after the intervention)2
Physical activity (PA) levels
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)3
Physical Activity Self-Efficacy (PASE)
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)4
Quality of life (QoL)
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
Time frame
Time Point 1 (at 1 month after the intervention), Time Point 3 (at 6 months after the intervention)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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