NCT07737418

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P75+ for not_applicable leukemia

Timeline
37mo left

Started Jan 2027

Typical duration for not_applicable leukemia

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

3 years

First QC Date

July 24, 2026

Last Update Submit

July 30, 2026

Conditions

Keywords

LeukemiaPhysical ActivitySelf-EfficacyParent-Child DyadQuality of LifeRandomized Controlled TrialMaintenance TherapyUnder treatmentExerciseDyadic interventionPediatric oncology

Outcome Measures

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).

    Baseline and 12 months(T4)

Secondary Outcomes (3)

  • Self-Reported Physical Activity Level

    Baseline, 3 months (T1), 6 months (T2), 9 months (T3), and 12 months (T4)

  • Health-Related Quality of Life Score (EQ-5D-Y-5L)

    Baseline, 3 months (T1), 6 months (T2), 9 months (T3), and 12 months (T4)

  • Physical Activity Self-Efficacy Score

    Baseline, 3 months (T1), 6 months (T2), 9 months (T3), and 12 months (T4)

Study Arms (3)

Dyadic Intervention

EXPERIMENTAL

Parent-child dyads complete a 3-month, 12-session physical activity program together, with intensity tailored to each child.

Behavioral: Dyadic Physical Activity Intervention

Individual Intervention

ACTIVE COMPARATOR

Children complete the same 3-month, 12 weekly sessions physical activity program as the dyadic group, but without parental participation.

Behavioral: Individual Intervention

Control

ACTIVE COMPARATOR

Children receive 12 weekly sessions of simple psychological support over 3 months, without a physical activity component.

Behavioral: Psychological Support

Interventions

Parent-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.

Dyadic Intervention

Children 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.

Individual Intervention

Children receive 12 weekly sessions of simple psychological support over 3 months, delivered by a trained Research Assistant, without a physical activity component.

Control

Eligibility Criteria

Age9 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children aged 9-18 years old
  • Diagnosed with leukaemia
  • Currently undergoing maintenance therapy
  • Have a parent willing to participate in the study
  • Both the child and participating parent speak Cantonese and read Chinese

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

LeukemiaSedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 24, 2026

First Posted

July 30, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

July 31, 2026

Record last verified: 2026-07