Dyadic Physical Activity Intervention for Children Undergoing Cancer Treatment (DYAD-PA)
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
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Ka Wai Katherine LAM
- Telefoonnummer: +852 27666420
- E-mail: kw-katherine.lam@polyu.edu.hk
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Dyadic Intervention
Parent-child dyads complete a 3-month, 12-session physical activity program together, with intensity tailored to each child.
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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.
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Actieve vergelijker: Individual Intervention
Children complete the same 3-month, 12 weekly sessions physical activity program as the dyadic group, but without parental participation.
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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.
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Actieve vergelijker: Control
Children receive 12 weekly sessions of simple psychological support over 3 months, without a physical activity component.
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Children receive 12 weekly sessions of simple psychological support over 3 months, delivered by a trained Research Assistant, without a physical activity component.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Physical Activity Level
Tijdsspanne: Baseline and 12 months（T4）
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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).
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Baseline and 12 months（T4）
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Self-Reported Physical Activity Level
Tijdsspanne: Baseline, 3 months (T1), 6 months (T2), 9 months (T3), and 12 months (T4)
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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).
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Baseline, 3 months (T1), 6 months (T2), 9 months (T3), and 12 months (T4)
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Physical Activity Self-Efficacy Score
Tijdsspanne: Baseline, 3 months (T1), 6 months (T2), 9 months (T3), and 12 months (T4)
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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.
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Baseline, 3 months (T1), 6 months (T2), 9 months (T3), and 12 months (T4)
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Health-Related Quality of Life Score (EQ-5D-Y-5L)
Tijdsspanne: Baseline, 3 months (T1), 6 months (T2), 9 months (T3), and 12 months (T4)
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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.
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Baseline, 3 months (T1), 6 months (T2), 9 months (T3), and 12 months (T4)
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Dyadic PA Child Cancer
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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