Effects of Acceptance and Commitment Therapy on Fatigue Interference in Patients With Advanced Lung Cancer and Caregiver Burden: A Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Recruimtment rate
研究概览
简要总结
Lung cancer is a malignant tumour 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 stages. Cancer-related fatigue is the most common and distressing symptom reported by lung cancer patients. For cancer patients, fatigue has a lasting impact on physical, psychological and social functions, and interferes with activities and participating in life events, thereby worsening the health-related quality of life. Family members have a key role in providing advanced lung cancer patients with informational, instrumental, and emotional support, which is crucial to patients' adaptation to the advanced illness and living a meaningful cancer life. Acceptance and Commitment Therapy (ACT) is the third-wave cognitive behavioural therapy to improve functioning and health-related quality of life by increasing psychological flexibility. The study aims to examine test the feasibility and acceptability, and preliminary effects of online ACT on fatigue interference in patients with advanced lung cancer and caregiver burden.
详细描述
A two-arm, assessor-blind randomised controlled trial will be conducted to investigate the effects of ACT on advanced lung cancer patients and caregivers compared to educational control. Participants in the same ward will be randomised 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 sizes of 4 and 6 to avoid selection bias. The study aims to examine the feasibility and acceptability, and preliminary effects of online ACT on fatigue interference in patients with advanced lung cancer and caregiver burden. The Specific objectives are:
- To investigate the feasibility and acceptability of the online 6-week ACT in patients with advanced lung cancer and caregivers in rural areas in China;
- To investigate the preliminary effects of the online 6-week ACT in patients with advanced lung cancer and caregivers in rural areas in China;
- To explore how patients and caregivers perceive the ACT experience during the intervention process.
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 assessor who is independent of 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;
- •lived in rural areas;
- •experienced unexplained fatigue syndrome: the score of 3 or more on the Fatigue Symptom Inventory (FSI);
- •able to provide informed consent and effectively collect data;
- •a consenting primary family caregiver; and
- •working phone service
排除标准
- •diagnosed with cognitive dysfunction or other mental illnesses that may interfere with their completion of treatment;
- •who are at critical condition; 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
Recruimtment rate
时间窗: Before baseline
The recruitment rate is defined as the percentage of participants who consented to participate in the study amongst the participants eligible for the study
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 6-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 from baseline in the score of caregiver burden assessed by The Zarit Caregiver Burden Inventory at one week after the intervention
时间窗: Baseline (T0) and post-intervention (T1, one week after the 6-week intervention)
12 items score from 1(not always) to 5 (always) to assess caregiver burdens of caregivers of advanced lung cancer patients, including three domains: role strain, self-criticism, and negative emotion. The overall score can be obtained by adding all subscale scores. 12 indicates low caregiver burden and 60 indicates the highest caregiver burden.
Adherence rate
时间窗: After the 6-week intervention
The adherence rate is defined as the frequency of the practice of mindfulness and session attendance
Eligibility rate
时间窗: Before baseline
The eligiblity rate is defined as the percentage of participants fulfilling the inclusion criteria amongst the participants screened for the eligibility
Attrition rate
时间窗: After the 6-week intervention
The attrition rate is defined as the percentage of participants who withdrew from the study before completion
次要结局
- Change from baseline in the score of mindful attention assessed by Mindful Attention Awareness Scale at one week after the intervention(Baseline (T0) and post-intervention (T1, one week after the 6-week intervention))
- Change from baseline in the score of meanfing of life assessed by The Meaning of Life questionnaire (MLQ) at one week after the intervention(Baseline (T0) and post-intervention (T1, one week after the 6-week intervention))
- 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(Baseline (T0) and post-intervention (T1, one week after the 6-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 post-intervention (T1, one week after the 6-week intervention))
研究者
Huiyuan LI
Principal Investigator
Chinese University of Hong Kong