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
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ka Wai Katherine LAM
- 전화번호: +852 27666420
- 이메일: kw-katherine.lam@polyu.edu.hk
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Dyadic Intervention
Parent-child dyads complete a 3-month, 12-session physical activity program together, with intensity tailored to each child.
|
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.
|
|
활성 비교기: 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.
|
|
활성 비교기: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Physical Activity Level
기간: 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）
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Self-Reported Physical Activity Level
기간: 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
기간: 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)
기간: 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)
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .