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Набор скоро начнётся NCT07621887

Digitalized Exercise Fit Tool Intervention for Adolescents With Blood Cancer

Без фазы С лечением Hematologic Cancer Leukaemia Lymphoma Physical Activity

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: Digitalized Exercise Fit Tool Intervention, Usual Care.
Кому может быть актуально
Состояния в реестре: Hematologic Cancer, Leukaemia, Lymphoma, Physical Activity. Базовые параметры: 12 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

Digitalised Exercise Fit Tool Intervention for Adolescents With Hematologic Cancer

Обзор

The goal of this clinical trial is to learn if a digitalised Exercise Fit Tool (EFT) mobile application can promote physical activity in adolescents aged 12-18 years who have completed treatment for hematologic cancer (e.g., leukaemia and lymphoma). The main questions it aims to answer are: 1. Is it feasible to conduct a larger randomised controlled trial of the digitalised EFT intervention? 2. Does the digitalised EFT intervention improve physical activity levels, physical activity self-efficacy, and quality of life at 6 months? Researchers will compare the digitalised EFT intervention group to a usual care group to see if the mobile application can promote physical activity levels, physical activity self-efficacy, and quality of life in adolescents with hematologic cancer.Participants will: 1. Receive a 20-minute educational session on how to use the mobile application 2. Use the mobile application to self-assess their appropriate physical activity level and exercise with a virtual coach 3. Complete questionnaires and wear an accelerometer at 1, 3, and 6 months after enrollment 4. Attend a 20-30-minute individual interview at 6 months (intervention group only, 10 participants)

Вмешательства

  • Поведенческое Digitalized Exercise Fit Tool Intervention
    Participants in the intervention group will be delivered a 20-minute educational session to the participants. During this session, participants will be educated about the introduction and operation of the mobile application.
  • Поведенческое Usual Care
    Participants in the control group will receive usual care with treatment and follow-ups from the hospital.

Первичные конечные точки

  • Screening rate [Срок оценки: During the recruitment period (up to 6 months)]
  • Eligibility rate [Срок оценки: During the recruitment period (up to 6 months)]
  • Consent rate [Срок оценки: During the recruitment period (up to 6 months)]
  • Randomization rate [Срок оценки: Time Point 1 (at 1 month after intervention)]
  • Attendance rate [Срок оценки: Time Point 1 (at 1 month after intervention)]
  • Retention rate [Срок оценки: Time Point 3 (at 6 months after intervention)]
  • Adherence rate [Срок оценки: Time Point 1 (at 1 month after intervention)]
  • Complete rate [Срок оценки: Time Point 1 (at 1 month after the intervention), Time Point 2 (at 3 month after intervention), Time Point 3 (at 6 months after intervention)]
  • Proportion of missing data [Срок оценки: Time Point 3 (at 6 months after the intervention)]
  • Adverse events [Срок оценки: Time Point 3 (at 6 months after the intervention)]
Вторичные конечные точки (4)
  • Physical activity (PA) levels [Срок оценки: Time Point 1 (at 1 month after intervention), Time Point 3 (at 6 months after the intervention)]
  • Physical activity (PA) levels [Срок оценки: Time Point 1 (at 1 month after the intervention), Time Point 3 (at 6 months after the intervention)]
  • Physical Activity Self-Efficacy (PASE) [Срок оценки: Time Point 1 (at 1 month after the intervention), Time Point 3 (at 6 months after the intervention)]
  • Quality of life (QoL) [Срок оценки: Time Point 1 (at 1 month after the intervention), Time Point 3 (at 6 months after the intervention)]

Критерии участия

Критерии включения

  • (1) they are 12-18 years old;
  • (2) they had been diagnosed with hematologic cancer such as leukaemia and lymphoma;
  • (3) they are regarded by the responsible physicians as stable, able to conduct PA, and without any PA restrictions,
  • (4) they completed all cancer treatment;
  • (5) they speak Cantonese and read Chinese.

Критерии исключения

  • (1) Receiving palliative care
  • (2) Have physical or cognitive impairment and learning problems as identified from medical records
  • (3) Identified by physicians that no physical activity should be conducted at the time of recruitment

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
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07621887 · dEFT Adolescent

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗