Dyadic Physical Activity Intervention for Children Undergoing Cancer Treatment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-18
SponsorThe Hong Kong Polytechnic University
About this trial
The goal of this study is to learn if a parent-child dyadic physical activity (PA) intervention works to improve physical activity levels in children with leukaemia. It will also learn about the intervention's effects on children's self-confidence in doing physical activity and their quality of life. The main questions it aims to answer are:
Does the dyadic PA intervention increase the amount of physical activity children do, compared with an individual PA intervention or usual care? Does the dyadic PA intervention improve children's confidence in doing physical activity and their overall quality of life? What is the cost-effectiveness of the dyadic intervention relative to the individual intervention and psychological support control group?
Researchers will compare three groups: children and parents doing physical activity together (dyadic intervention), children doing physical activity individually (individual intervention), and children receiving psychological support sessions only (control group), to see if involving parents makes a difference.
Participants will:
Attend weekly sessions for 3 months (12 sessions total) Wear an activity tracker for 7 days and complete questionnaires at 5 different time points over 12 months Some participants will also be invited to take part in an interview about their experience
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged 9-18 years old
Diagnosed with leukaemia
Currently undergoing maintenance therapy
Have a parent willing to participate in the study
Disqualifiers
Children under palliative care with evidence of cancer recurrence or second malignancies
Children with medical contraindications for PA, such as thrombosis, as documented by physicians
Children or parents with physical impairment or cognitive and learning problems (identified from medical records)
Participants in the team's other interventional studies
Trial design
Design model
Parallel
Treatments tested in this trial
Dyadic Physical Activity Intervention
BehavioralParent-child dyads receive a structured physical activity intervention delivered by a trained Research Assistant over 12 weekly sessions across 3 months. Parents perform the physical activity together with their child in each session. Exercise intensity is individually tailored to each child.
Individual Intervention
BehavioralChildren receive the same structured 12-session, weekly physical activity intervention as the dyadic group, delivered over 3 months by a trained Research Assistant, without parental participation. Exercise intensity is individually tailored to each child.
Psychological Support
BehavioralChildren receive 12 weekly sessions of simple psychological support over 3 months, delivered by a trained Research Assistant, without a physical activity component.
Treatment groups
198 Participants
are divided into 3 treatment groupsGroup A: Dyadic InterventionExperimental treatment 1 intervention
Group B: Individual InterventionActive comparator 1 intervention
Group C: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Physical Activity Level
Children's physical activity levels will be objectively measured using ActiGraph GT3X accelerometers, worn for 7 consecutive days at each assessment timepoint. The primary outcome is the minutes engaged in moderate-to-vigorous physical activity (MVPA).
Time frame
Baseline and 12 months（T4）Secondary outcomes
1
Self-Reported Physical Activity Level
Children's self-reported PA levels measured using the Chinese University of Hong Kong: Physical Activity Rating for Children and Youth, an 11-point scale (0-10) asking children to self-rate their PA levels in the past 7 days, from 0 (no exercise at all) to 10 (vigorous exercise on most days).
Time frame
Baseline, 3 months (T1), 6 months (T2), 9 months (T3), and 12 months (T4)2
Health-Related Quality of Life Score (EQ-5D-Y-5L)
Children's health-related quality of life will be measured using the EQ-5D-Y-5L. It includes a descriptive system covering five health dimensions, each scored from 1 to 5, with higher scores indicating worse outcomes, and the EQ visual analogue scale , scored from 0 to 100, with higher scores indicating better outcomes.
Time frame
Baseline, 3 months (T1), 6 months (T2), 9 months (T3), and 12 months (T4)3
Physical Activity Self-Efficacy Score
Children's physical activity self-efficacy will be assessed using the five-item Physical Activity Self-Efficacy Scale. Each item is rated on a three-point Likert scale. Total scores range from 5 to 15, with higher scores indicating greater physical activity self-efficacy.
Time frame
Baseline, 3 months (T1), 6 months (T2), 9 months (T3), and 12 months (T4)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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