Tai-Chi and Aerobic Exercise to Improve Emotional Symptom Cluster in Late-stage Lung Cancer Patients

Обзор

The goal of this randomized controlled trial is to investigate the effects of Tai-Chi and aerobic exercise on the emotional symptom cluster, and the underlying mechanism of that cluster, in late-stage lung cancer patients. Participants will be randomized into one of three groups: 1) Tai-Chi group, 2) aerobic exercise group, or 3) self-management control group. Both the Tai-Chi and aerobic exercise groups will attend twice-weekly group classes for 16 weeks (32 total contact hours). The self-management control group will receive written information regarding the recommended level of physical activity.

Подробное описание

Late-stage lung cancer patients (n = 318) meeting the inclusion criteria will be recruited and randomized into one of three groups: 1) Tai-Chi group, 2) aerobic exercise group, or 3) self-management control group. Both the Tai-Chi and aerobic exercise groups will attend twice-weekly group classes for 16 weeks (32 total contact hours). The self-management control group will receive written information regarding the recommended level of physical activity. To evaluate the effectiveness of Tai-Chi and aerobic exercise in alleviating the emotional symptom cluster (primary outcome) and individual symptoms (sleep disturbance, anxiety, depression, fatigue), outcome measures will be conducted at baseline, 8 weeks (mid-point assessment), 16 weeks (post-intervention), and 28 weeks (12-weeks post-intervention). A linear mixed-effects model will be used to study the between-group differences in outcomes. In addition, emotion regulation, mindfulness, and cardiorespiratory fitness will be evaluated at each data collection point, and structural equation modeling will be used for subsequent mediation analysis to determine their mediating role in outcome changes. Qualitative interviews will be conducted to understand patients' experience and evaluation of the interventions.

Вмешательства

• Поведенческое Tai-Chi intervention
  The standardized 16-form Yang-style Tai-Chi exercise set will be adopted. Group classes will take place in a community center twice a week for 16 weeks, with each class lasting approximately 60 minutes. Classes will be taught by an experienced Tai-Chi master. Patients will be instructed to practice the Tai-Chi exercises at home at least 3 times a week (30 min each time for a total of 90 min). Patients will be provided with a daily exercise log to record their exercise type, frequency, and intens
• Поведенческое Aerobic exercise intervention
  The aerobic exercise class will be designed to cover both aerobic and resistance exercises. Group classes will take place in an exercise center twice a week for 16 weeks, with each class lasting approximately 60 minutes. Each class will be led by a certified exercise specialist. Patients will be provided with a daily exercise log to record their exercise type, frequency, and intensity.

Первичные конечные точки

• Change from Baseline Emotional symptom cluster at 8 weeks [Срок оценки: 8 weeks]
• Change from Baseline Emotional symptom cluster at 16 weeks [Срок оценки: 16 weeks]
• Change from Baseline Emotional symptom cluster at 28 weeks [Срок оценки: 28 weeks]

Вторичные конечные точки (12)

• Change from Baseline Sleep disturbance at 8 weeks [Срок оценки: 8 weeks]
• Change from Baseline Sleep disturbance at 16 weeks [Срок оценки: 16 weeks]
• Change from Baseline Sleep disturbance at 28 weeks [Срок оценки: 28 weeks]
• Change from Baseline Fatigue at 8 weeks [Срок оценки: 8 weeks]
• Change from Baseline Fatigue at 16 weeks [Срок оценки: 16 weeks]
• Change from Baseline Fatigue at 28 weeks [Срок оценки: 28 weeks]
• Change from Baseline Anxiety and depression at 8 weeks [Срок оценки: 8 weeks]
• Change from Baseline Anxiety and depression at 16 weeks [Срок оценки: 16 weeks]
• Change from Baseline Anxiety and depression at 28 weeks [Срок оценки: 28 weeks]
• Change from Baseline Emotion regulation at 8 weeks [Срок оценки: 8 weeks]
• Change from Baseline Emotion regulation at 16 weeks [Срок оценки: 16 weeks]
• Change from Baseline Emotion regulation at 28 weeks [Срок оценки: 28 weeks]

Критерии участия

Критерии включения

• diagnosed with stage IIIB or IV non-small cell lung cancer confirmed by pathology, with no other cancer diagnosis within the previous year;
• a current Eastern Cooperative Oncology Group Performance Status of 0-2;
• experience of sleep disturbance, anxiety, depression, and fatigue in the past week (rating of 1 or more on a 0-10 numeric rating scale \[NRS\] for each symptom);
• able to communicate in Cantonese, Mandarin, or English;
• conscious and alert

Критерии исключения

• suffering from a condition that hinders exercise performance (e.g., active neurological disorder, recent heart attack);
• currently participating in any other exercise or mind-body classes; or 3) performing regular exercises, defined as at least 150 minutes of moderate-intensity exercise weekly

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

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Гонконг · 1 центр

• Queen Mary Hospital — Гонконг

Идентификаторы

NCT: NCT05778708 · UW22-583

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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