A Brief Mobile SMART Exercise Support Program to Improve Fatigue in Patients With Advanced Lung Cancer - A Pragmatic Randomized Controlled Trial With Outcome and Process Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in fatigue level
研究概览
简要总结
Lung cancer (LC) is a common cancer in the world. Among all symptoms, Fatigue is considered as the most distressing medical condition of LC. Prior studies revealed that physical activity effectively relieve fatigue and related problems. The current study attempt to explore the effectiveness of SMART Exercise Support Program (SES) with the use of mobile instant messaging application, on reducing symptoms such as fatigue, and improving physical activity level, physical fitness performance, sleep quality and habits, and quality of life in advanced lung cancer (ALC) patients.
详细描述
Lung cancer (LC) is the most and second most common cancer globally and locally, respectively. Nearly half of LC patients are diagnosed in the advanced stage. Fatigue is perceived to be the most distressing symptom. Physical activity has been proposed as an alternative treatment to relieve fatigue and related problems.
Mobile instant messaging applications (e.g. WhatsApp/WeChat) are popular and inexpensive for interactive messaging. A systematic review showed a majority of messaging interventions were effective in diabetes self-management, weight loss, physical activity (PA), smoking cessation, and medication adherence.
The proposed randomized controlled trial (RCT) aims to examine the effectiveness of SES on relieving fatigue, pain, dyspnea, happiness, anxiety and depression symptoms, physical activity level, physical fitness performance, sleep quality and habits, and quality of life in ALC patients (SES group), compared to the General Hygiene Information (GHI, control) group.
Questionnaires and simple fitness tests will be used at baseline, 6-week, and 24-week assessments. Qualitative feedback will be obtained at the completion of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor did not aware of which groups the patients belongs to.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years and above;
- •Diagnosis of Stage III or IV non-small cell lung cancer;
- •Edmonton Symptom Assessment System Scale fatigue symptom score ≥4 out of 10
- •Self-reported engagement of <150 minutes of moderate intensity PA each week,
- •Ambulatory and capable of all self-care activities (European Co-operative Oncology Group (ECOG) Performance Status of ≤2)
- •Either undergoing or finished oncology therapy, biological agents and/or support care;
- •Mentally, cognitively and physically fit to join the trial as determined by the doctor in-charge and responsible clinical investigators;
- •Able to speak and read Chinese;
- •Willing to complete the patient-reported outcome questionnaire;
- •Completion of the Physical Activity Readiness Questionnaire; and
- •Possession of a smartphone with instant messaging functions such as WhatsApp or WeChat.
排除标准
- •Those preparing for lung operation;
- •Skeletal fragility;
- •Serious active infection;
- •Inability to walk;
- •Previously untreated symptomatic brain metastases;
- •Severe respiratory insufficiency;
- •Uncontrolled pain; or
- •Diagnosed psychiatric illness with or without medication such as major depressive disorder.
结局指标
主要结局
Change in fatigue level
时间窗: Baseline and 6 weeks
Measured by a 13-item Functional Assessment of Cancer Therapy - Fatigue subscale. The level of fatigue is measured on a five-point Likert scale. The scale range is 0 to 52, with 0 being the worst possible score and 52 being the best possible score indicating no fatigue.
次要结局
- Change in depression symptoms(Baseline, 6 weeks, 6 months)
- Change in grip strength(Baseline, 6 weeks and 6 months)
- Change in exercise self-efficacy(Baseline, 6 weeks and 6 months)
- Change in balance(Baseline, 6 weeks and 6 months)
- Change in flexibility(Baseline, 6 weeks, and 6 months)
- Change in sleep and wake intervals(Baseline, 6 weeks , and 6 months)
- Change in anxiety symptoms(Baseline, 6 weeks, 6 months)
- Change in health-related quality of life(Baseline, 6 weeks, 6 months)
- Change in objective physical activity levels, including duration, frequency and intensity(Baseline, 6 weeks, and 6 months)
- Change in exercise capacity(Baseline, 6 weeks and 6 months)
- Change in fatigue level(Baseline and 6 months)
- Change in physical activity level(Baseline, 6 weeks, 6 months)
- Change in social and family support(Baseline, 6 weeks and 6 months)
- Change in lower limb strength(Baseline, 6 weeks, and 6 months)
- Change in sleep quality(Baseline, 6 weeks, 6 months)
- Change in happiness level(Baseline, 6 weeks, 6 months)
- Change in cancer-related symptoms(Baseline, 6 weeks and 6 months)
- Change in acceptance of illness(Baseline, 6 weeks and 6 months)
研究者
Dr. Agnes Yuen-Kwan Lai
Assistant professor
The University of Hong Kong