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Набор скоро начнётся NCT07737418

Dyadic Physical Activity Intervention for Children Undergoing Cancer Treatment

Без фазы С лечением Leukemia Physical Inactivity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Dyadic Physical Activity Intervention, Individual Intervention, Psychological Support.
Кому может быть актуально
Состояния в реестре: Leukemia, Physical Inactivity. Базовые параметры: 9 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Dyadic-based Physical Activity Intervention for Children Who Are Undergoing Cancer Treatment: A Randomized Controlled Trial

Обзор

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

Вмешательства

  • Поведенческое Dyadic Physical Activity Intervention
    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.
  • Поведенческое Individual Intervention
    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.
  • Поведенческое Psychological Support
    Children receive 12 weekly sessions of simple psychological support over 3 months, delivered by a trained Research Assistant, without a physical activity component.

Первичные конечные точки

  • Physical Activity Level [Срок оценки: Baseline and 12 months（T4）]
Вторичные конечные точки (3)
  • Self-Reported Physical Activity Level [Срок оценки: Baseline, 3 months (T1), 6 months (T2), 9 months (T3), and 12 months (T4)]
  • Health-Related Quality of Life Score (EQ-5D-Y-5L) [Срок оценки: Baseline, 3 months (T1), 6 months (T2), 9 months (T3), and 12 months (T4)]
  • Physical Activity Self-Efficacy Score [Срок оценки: Baseline, 3 months (T1), 6 months (T2), 9 months (T3), and 12 months (T4)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07737418 · Dyadic PA Child Cancer

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗