Effectiveness of Acceptance and Commitment Therapy on Fatigue Interference and Health-related Quality of Life Among Patients With Advanced Lung Cancer: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Change from baseline in the score of the score of fatigue interference assessed by The Fatigue Symptom Inventory at three months after the 4-week intervention
研究概览
简要总结
Lung cancer is a malignant tumor that has transformed from a single cancer disease into one of the most striking global health problems. Lung cancer has an insidious onset, and most patients are first diagnosed with the middle and advanced stage. Cancer related fatigue is the most common and distressing symptom reported by lung cancer patients. For cancer patients, fatigue has lasting impact on physical, psychological and social functions, interferes with activities and participating in life events, thereby worsening the health-related quality of life. Acceptance and Commitment Therapy (ACT) is the third-wave cognitive behavioral therapy to improve functioning and health-related quality of life by increasing psychological flexibility. The study aims to examine the effectiveness of ACT on fatigue interference and health-related quality of life in patients with advanced lung cancer.
详细描述
A two-arm, assessor-blind randomized controlled trial will be conducted to investigate the effects of ACT on advanced lung cancer patients compared to usual care. Participants in the same ward will be randomized at a 1:1 ratio to the intervention group or control group. Block randomization will be conducted by an independent research assistant using randomly varying block size of 4, 6 to avoid selection bias. The study aims to examine the effectiveness of ACT on fatigue interference and health-related quality of life in patients with advanced lung cancer. The Specific objectives are: 1) To investigate the effects of ACT on primary outcomes: fatigue interference and health-related quality of life compared to control group at post-intervention and three months follow-up. 2) To investigate the effects of ACT on the secondary outcomes: cancer-related fatigue, depressive symptoms, anxiety, distress and exercise capacity and process outcomes including psychological flexibility, ACT related variables (acceptance and cognitive defusion) at post-intervention and three months follow-up.
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 outcomes assessors who are independent with the research will be trained before formally conducting data collecting.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18 or over;
- •diagnosed with stage III or stage IV lung cancer by pathological section or cytology;
- •experienced unexplained fatigue syndrome: the score of 3 or more on the Fatigue Symptom Inventory (FSI); and
- •able to provide informed consent and effectively collect data.
排除标准
- •diagnosed with cognitive dysfunction or other mental illnesses that may interfere with their completion of treatment;
- •who are with a life expectancy <3 months, or whose physical conditions are considered ineligible for the present study based on the physician's judgment; and
- •who are receiving or have just completed other lung cancer-related intervention programs within the last six months
结局指标
主要结局
Change from baseline in the score of the score of fatigue interference assessed by The Fatigue Symptom Inventory at three months after the 4-week intervention
时间窗: Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)
A 13-item instrument that measures the intensity and interference of fatigue over the previous 7 days. The first four items are used to assess the intensity of fatigue, Item 5 - Item 11 are to assess the degree to which fatigue in the past week was judged to interfere with different aspects, such as general activity, bathe and dress ability, work activity, concentration ability, relation with others, enjoyment of life and mood, using a 11-point Likert scale ranging from 0 (no interference) to 10 (extreme interference). 0 indicates no fatigue and 127 indicates the worst fatigue intensity and interference. Change= (Three months after the intervention score - Baseline score)
Change from baseline in the score of health-related quality of life assessed by Functional Assessment of Cancer Therapy - Lung, Version 4 at one week after the intervention
时间窗: Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)
36 items scored from 0 (not at all) to 4 (very much) to assess QoL of lung cancer patients, including 5 domains: physical, social/family, emotional, and functional well-being, and additional concerns about lung cancer. The overall score can be obtained by adding all subscale scores. 0 indicates no quality of life and 144 indicates the highest quality of life. Change= (One week after the intervention score - Baseline score)
Change from baseline in the score of health-related quality of life assessed by Functional Assessment of Cancer Therapy - Lung, Version 4 at three months after the 4-week intervention
时间窗: Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)
36 items scored from 0 (not at all) to 4 (very much) to assess QoL of lung cancer patients, including 5 domains: physical, social/family, emotional, and functional well-being, and additional concerns about lung cancer. The overall score can be obtained by adding all subscale scores. 0 indicates no quality of life and 144 indicates the highest quality of life. Change= (Three months after the intervention score - Baseline score)
Change from baseline in the score of fatigue interference assessed by The Fatigue Symptom Inventory at one week after the intervention
时间窗: Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)
A 13-item instrument that measures the intensity and interference of fatigue over the previous 7 days. The first four items are used to assess the intensity of fatigue, Item 5 - Item 11 are to assess the degree to which fatigue in the past week was judged to interfere with different aspects, such as general activity, bathe and dress ability, work activity, concentration ability, relation with others, enjoyment of life and mood, using a 11-point Likert scale ranging from 0 (no interference) to 10 (extreme interference). 0 indicates no fatigue and 127 indicates the worst fatigue intensity and interference. Change= (One week after the intervention score - Baseline score)
次要结局
- Change from baseline in the score of cancer related fatigue assessed by The Multidimensional Fatigue Inventory at one week after the intervention(Baseline (T0) and post-intervention (T1, one week after the 4-week intervention))
- Change from baseline in the score of cancer related fatigue assessed by The Multidimensional Fatigue Inventory at three months after the intervention(Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention))
- Change from baseline in the score of anxiety assessed by Generalized Anxiety Disorder Scale (GAD-7) at three months after the intervention.(Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention))
- Change from baseline in the score of depressive symptoms assessed by The Patient Health Questionnaire (PHQ-9) at one week after the intervention.(Baseline (T0) and post-intervention (T1, one week after the 4-week intervention))
- Change from baseline in the score of depressive symptoms assessed by The Patient Health Questionnaire (PHQ-9) at three months after the intervention.(Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention))
- Change from baseline in the score of anxiety assessed by Generalized Anxiety Disorder Scale (GAD-7) at one week after the intervention.(Baseline (T0) and post-intervention (T1, one week after the 4-week intervention))
- Change from baseline in the score of psychological distress assessed by Impact of Events Scale -Revised version at one week after the intervention.(Baseline (T0) and post-intervention (T1, one week after the 4-week intervention))
- Change from baseline in the score of psychological distress assessed by Impact of Events Scale -Revised version at three months after the intervention.(Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention))
- Change from baseline in the score of psychological flexibility assessed by Comprehensive assessment of Acceptance and Commitment Therapy processes at one week after the intervention(Baseline (T0) and post-intervention (T1, one week after the 4-week intervention))
- Change from baseline in exercise capacity assessed by self-designed questions at one week after the intervention(Baseline (T0) and post-intervention (T1, one week after the 4-week intervention))
- Change from baseline in exercise capacity assessed by self-designed questions at three months after the intervention(Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention))
- Change from baseline in the score of psychological flexibility assessed by Comprehensive assessment of Acceptance and Commitment Therapy processes at three months after the intervention(Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention))
- Change from baseline in the score of acceptance assessed by Acceptance and Action Cancer Questionnaire at one week after the intervention(Baseline (T0) and post-intervention (T1, one week after the 4-week intervention))
- Change from baseline in the score of acceptance assessed by Acceptance and Action Cancer Questionnaire at three months after the intervention(Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention))
- Change from baseline in the score of cognitive fusion assessed by Cognitive Fusion Questionnaire at one week after the intervention(Baseline (T0) and post-intervention (T1, one week after the 4-week intervention))
- Change from baseline in the score of cognitive fusion assessed by Cognitive Fusion Questionnaire at three months after the intervention(Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention))
研究者
Huiyuan LI
Principal Investigator
Chinese University of Hong Kong