Acupressure for Cough in Lung Cancer Survivors: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Cough
研究概览
简要总结
The goal of this randomized controlled trial is to examine the effect of an acupressure intervention in alleviating cough and reducing co-occurring symptoms (dyspnea, cough, and fatigue) in patients with lung cancer.
The hypotheses are:
- Acupressure can alleviate cough in lung cancer survivors;
- Acupressure can reduce a cough-related symptom cluster (dyspnea-cough-fatigue) experienced by lung cancer survivors;
- Acupressure can reduce the symptom burden and improve the health-related quality of life and functional capacity of lung cancer survivors experiencing cough.
Participants will:
Receive acupressure for 8 weeks or receive an education booklet; Keep a diary of their acupressure practice and symptoms; Be assessed at baseline (T0), early intervention (T1), post-intervention (T2), and 8 weeks after the intervention period (T3).
详细描述
Lung cancer survivors often exhibit multiple symptoms, among which cough and its co-occurring symptoms have been identified as a group of prevalent and persistent symptoms that substantially impact their quality of life and overall survival. Research has identified cough as the sentinel symptom of the respiratory symptom cluster in lung cancer patients, underscoring the critical need for effective management strategies. This randomized controlled trial aims to evaluate the effect of a safe and self-administerable acupressure intervention on alleviating cough, reducing the dyspnea-cough-fatigue symptom cluster, and improving symptom burden, functional capacity, and quality of life in this patient population.
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
- None
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
- •be at least 18 years of age;
- •have a diagnosis of LC at any stage and of any pathological type;
- •have a cough symptom rating ≥3 on a 0 to 10 numeric rating scale within 7 days preceding enrollment;
- •can perform acupressure independently in daily activities;
- •be able to read Chinese and communicate in Cantonese or Mandarin;
- •be able to provide informed consent.
排除标准
- •have unstable chronic diseases other than LC;
- •have received acupressure or acupuncture within the three months preceding study enrollment;
- •have serious illnesses or other conditions that prevent the participants from following the intervention protocols;
- •have a life expectancy of less than 3 months;
- •Be currently participating in other research programs that may affect the outcomes under investigation.
研究组 & 干预措施
Acupressure
Participants will receive an 8-week acupressure intervention. After completing two hospital training sessions, the participants will perform acupressure every day for eight consecutive weeks in their daily activities following an evidence-based acupressure protocol, which will be developed based on the Chinese meridian theory, expert consensus and a comprehensive literature review of previous evidence on LC cough management. In the first week, two training sessions will be conducted to ensure the competency of the participants in performing acupressure. Afterwards, participants will be instructed to press each of the 15 designated acupoints until they experience sensations of soreness, numbness or distension, for 1 minute per time, at least two prescribed times daily (once between 9-11 am and once between 5-7 pm), and additionally during cough episodes, wherever they feel appropriate.
干预措施: acupressure (Behavioral)
Education
Participants will receive an educational booklet that includes information on the disease and treatments of LC, causes and consequences of cough, and advice on cough prevention and management.
干预措施: Education (Other)
结局指标
主要结局
Cough
时间窗: Pre-intervention (T0, baseline); Early intervention (T1, 1 week after T0); Post-intervention (T2, 8 weeks after T0); Follow-up (T3, 16 weeks after T0)
The cough will be evaluated using the Cough Evaluation Test (CET). The 5-item instrument assesses cough under physical, psychological and social domains, with each item graded on a five-point scale, with a higher total score indicating a greater level of symptom and an MCID of 2 points.
次要结局
- Dyspnea(Pre-intervention (T0, baseline); Early intervention (T1, 1 week after T0); Post-intervention (T2, 8 weeks after T0); Follow-up (T3, 16 weeks after T0))
- Functional capacity(Pre-intervention (T0, baseline); Post-intervention (T2, 8 weeks after T0); Follow-up (T3, 16 weeks after T0))
- Cough-related quality of life(Pre-intervention (T0, baseline); Early intervention (T1, 1 week after T0); Post-intervention (T2, 8 weeks after T0); Follow-up (T3, 16 weeks after T0))
- Dyspnea-cough-fatigue symptom cluster(Pre-intervention (T0, baseline); Early intervention (T1, 1 week after T0); Post-intervention (T2, 8 weeks after T0); Follow-up (T3, 16 weeks after T0))
- Fatigue(Pre-intervention (T0, baseline); Early intervention (T1, 1 week after T0); Post-intervention (T2, 8 weeks after T0); Follow-up (T3, 16 weeks after T0))
- Symptom burden(Pre-intervention (T0, baseline); Early intervention (T1, 1 week after T0); Post-intervention (T2, 8 weeks after T0); Follow-up (T3, 16 weeks after T0))
- Health-related quality of life(Pre-intervention (T0, baseline); Early intervention (T1, 1 week after T0); Post-intervention (T2, 8 weeks after T0); Follow-up (T3, 16 weeks after T0))
研究者
Cheung Shuk-Ting
Assistant Professor
The University of Hong Kong