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
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Ka Wai Katherine LAM
- Номер телефона: +852 27666420
- Электронная почта: kw-katherine.lam@polyu.edu.hk
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
Принимает здоровых добровольцев
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
|
|
Активный компаратор: 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.
|
|
Активный компаратор: 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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Physical Activity Level
Временное ограничение: 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）
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Self-Reported Physical Activity Level
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
|
Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- Dyadic PA Child Cancer
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .