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
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ka Wai Katherine LAM
- 電話番号：+852 27666420
- メール：kw-katherine.lam@polyu.edu.hk
参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Physical Activity Level
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Self-Reported Physical Activity Level
時間枠：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
時間枠：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)
時間枠：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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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