Dyadic Physical Activity Intervention for Children Undergoing Cancer Treatment (DYAD-PA)

July 30, 2026 updated by: Dr Katherine Lam, The Hong Kong Polytechnic University

Dyadic-based Physical Activity Intervention for Children Who Are Undergoing Cancer Treatment: A Randomized Controlled 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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
198

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dyadic Intervention
Parent-child dyads complete a 3-month, 12-session physical activity program together, with intensity tailored to each child.
Behavioral: Dyadic Physical Activity Intervention
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.
Active Comparator: Individual Intervention
Children complete the same 3-month, 12 weekly sessions physical activity program as the dyadic group, but without parental participation.
Behavioral: Individual 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.
Active Comparator: Control
Children receive 12 weekly sessions of simple psychological support over 3 months, without a physical activity component.
Behavioral: Psychological Support
Children receive 12 weekly sessions of simple psychological support over 3 months, delivered by a trained Research Assistant, without a physical activity component.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Physical Activity Level
Time Frame: Baseline and 12 months（T4）
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-Reported Physical Activity Level
Time Frame: Baseline, 3 months (T1), 6 months (T2), 9 months (T3), and 12 months (T4)
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).
Baseline, 3 months (T1), 6 months (T2), 9 months (T3), and 12 months (T4)
Physical Activity Self-Efficacy Score
Time Frame: Baseline, 3 months (T1), 6 months (T2), 9 months (T3), and 12 months (T4)
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.
Baseline, 3 months (T1), 6 months (T2), 9 months (T3), and 12 months (T4)
Health-Related Quality of Life Score (EQ-5D-Y-5L)
Time Frame: Baseline, 3 months (T1), 6 months (T2), 9 months (T3), and 12 months (T4)
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.
Baseline, 3 months (T1), 6 months (T2), 9 months (T3), and 12 months (T4)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Dyadic PA Child Cancer

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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