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Набор скоро начнётся NCT07437144

Exploring the Effects of Shangshou Daoyin Method on Improving Sleep Quality, Quality of Life, and TCM Constitution in Breast Cancer Patients With Insomnia

Без фазы С лечением Breast Cancer Patients Diagnosed With Stage 0-III

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: Shangshou Daoyin Method, Routine Nursing Care.
Кому может быть актуально
Состояния в реестре: Breast Cancer Patients Diagnosed With Stage 0-III. Базовые параметры: от 20 лет · Женщины.
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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Обзор

Breast cancer patients often experience insomnia and physical imbalances during and after treatment, indirectly affecting their quality of life. Therefore, the sleep quality, quality of life, and TCM constitution of breast cancer patients need to be taken seriously. Oral sleep aids are prone to causing additional side effects; therefore, in addition to medication, non-pharmacological therapies can be used to alleviate the insomnia caused by breast cancer patients, thereby improving their quality of life. Because guided exercises are simple to learn, gentle, safe, and can be performed without time constraints, clinicians can apply them to the care of breast cancer patients. It is hoped that the results of this study can provide a reference for other related research.

Вмешательства

  • Поведенческое Shangshou Daoyin Method
    During the trial, the intervention involved performing Shangshou Daoyin Method exercises at least three times a week,while the control group received only routine care for 12 weeks. During the intervention, daily reminders were sent via Line (to wear an activity tracker 30 minutes before bedtime to monitor sleep time and efficiency, and to review the sleep log every morning), and weekly reminders were sent to submit sleep time, efficiency, and seven-day sleep log results.
  • Поведенческое Routine Nursing Care
    Researchers provided individualized routine care and administered activity recorders, along with paper logbooks. Participants were instructed on how to fill out the logbook and use the activity recorder. After joining the official Line group, participants were instructed on how to use Line. In addition to daily reminders and support via Line, participants were asked to wear the activity recorder 30 minutes before bedtime and to regularly submit data via Line.

Первичные конечные точки

  • Chinese version of the Pittsburgh Sleep Quality Index (CPSQI) [Срок оценки: Baseline (Pre-test), Week 4, Week 8, and Week 12.]
Вторичные конечные точки (2)
  • European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire(EORTC QLQ-C30) [Срок оценки: Baseline (Pre-test), Week 4, Week 8, and Week 12.]
  • Body Constitution Questionnaire(BCQ) [Срок оценки: Baseline (Pre-test), Week 12.]

Критерии участия

Критерии включения

  • Breast cancer patients aged ≥20 years diagnosed with 0-III cancer, without any signs of metastasis or recurrence
  • Cases who have completed surgery, targeted therapy, chemotherapy, or radiotherapy at least 3 months ago.
  • Cases who have started taking anti-hormone inhibitors and traditional Chinese medicine for 3 months.
  • Pittsburgh Sleep Quality Scale (CPSQI) score ≥5.
  • Cases who are willing to participate and complete the consent form.

Критерии исключения

  • Patients with other cancers.
  • Illiterate
  • Patients with physical disabilities or inability to perform physical activities.
  • Patients diagnosed with mental illness by a physician.

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
Открытое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07437144 · CMUH114-REC2-225 · DMR-115-140

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗