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
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Ka Wai Katherine LAM
- Telefonnummer: +852 27666420
- E-Mail: kw-katherine.lam@polyu.edu.hk
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
|
Aktiver Komparator: Individual Intervention
Children complete the same 3-month, 12 weekly sessions physical activity program as the dyadic group, but without parental participation.
|
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.
|
|
Aktiver Komparator: Control
Children receive 12 weekly sessions of simple psychological support over 3 months, without a physical activity component.
|
Children receive 12 weekly sessions of simple psychological support over 3 months, delivered by a trained Research Assistant, without a physical activity component.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Physical Activity Level
Zeitfenster: 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）
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Self-Reported Physical Activity Level
Zeitfenster: 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
Zeitfenster: 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.
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Baseline, 3 months (T1), 6 months (T2), 9 months (T3), and 12 months (T4)
|
|
Health-Related Quality of Life Score (EQ-5D-Y-5L)
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Dyadic PA Child Cancer
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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