- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07315672
Acupressure for Cough in Lung Cancer Survivors
Acupressure for Cough in Lung Cancer Survivors: A Randomized Controlled Trial
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).
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mengyao Cao
- Phone Number: +852-96733602
- Email: u3590805@connect.hku.hk
Study Locations
-
-
Guangdong
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Shenzhen, Guangdong, China, 0755
- Recruiting
- University of Hong Kong-Shenzhen Hospital
-
Contact:
- Xian Chen
- Phone Number: +86 13728867748
- Email: chenx1@hku-szh.org
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Principal Investigator:
- Xian Chen
-
-
-
-
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Hong Kong, Hong Kong, 0000
- Not yet recruiting
- Queen Mary Hospital
-
Contact:
- Mengyao Cao
- Phone Number: +852-96733602
- Email: u3590805@connect.hku.hk
-
Contact:
- Email: u3590805@connect.hku.hk
-
Principal Investigator:
- Mengyao Cao
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
Participants will perform acupressure for 8 weeks and keep practice records in a diary log.
Trainers will follow up with the participants twice weekly via phone or face-to-face to assess and reinforce their practice and address acupressure-related questions.
|
|
Active Comparator: 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.
|
Participants will receive an educational booklet in the first week after the baseline assessment and complete evaluations concurrently with the experimental group.
Upon study completion, they will be offered a place on a waitlist for the same acupressure intervention provided to the experimental group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cough
Time Frame: 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.
|
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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cough-related quality of life
Time Frame: 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 Mandarin Chinese version of the Leicester Cough Questionnaire (LCQ-MC) will be used to assess cough-related quality of life.
The widely adopted questionnaire has established satisfactory internal consistency (with Cronbach's α between 0.74 and 0.90) and test-retest reliability (with intraclass correlation coefficients between 0.89 and 0.95).
The 19-item LCQ-MC has an MCID of 3.0 points.
A lower total score indicates a greater level of symptom severity and poorer 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
Time Frame: 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 dyspnea-cough-fatigue symptom cluster will be assessed in terms of the occurrence and severity.
The presence of the symptom cluster is defined as having all three symptoms.
Severity of the dyspnea-cough-fatigue symptom cluster will be quantified using the average score of all three items (dyspnea, cough, and fatigue) from the MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC).
|
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)
|
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Dyspnea
Time Frame: 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)
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Dyspnea will be measured using Dyspnea-12 (D-12).
The 12-item instrument consists of two subscales (physical and affective), with each item graded on a 4-point scale from 0 (no dyspnea) to 3 (severe dyspnea).
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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
Time Frame: 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 9-item Brief Fatigue Inventory (BFI) will be used to measure fatigue levels.
The instrument has two dimensions - severity and interference, with a higher total score indicating a greater 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)
|
|
Symptom burden
Time Frame: 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)
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The symptom burden of the participants will be measured using the MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC), which consists of 16 symptom items and 6 interference items.
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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)
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Functional capacity
Time Frame: Pre-intervention (T0, baseline); Post-intervention (T2, 8 weeks after T0); Follow-up (T3, 16 weeks after T0)
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Functional capacity will be assessed using the 6-minute Walking Test (6MWT), a valid and widely used test among patients with respiratory diseases.
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Pre-intervention (T0, baseline); Post-intervention (T2, 8 weeks after T0); Follow-up (T3, 16 weeks after T0)
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Health-related quality of life
Time Frame: 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)
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Health-related quality of life will be measured with the 36-item Functional Assessment of Cancer Therapy-Lung (FACT-L) under five dimensions: physical, emotional, social, functional well-being, and LC-specific symptoms.
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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)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Denise Shuk Ting Cheung, PhD, The University of Hong Kong
Publications and helpful links
General Publications
- Luo Y, Luo J, Su Q, Yang Z, Miao J, Zhang L. Exploring Central and Bridge Symptoms in Patients with Lung Cancer: A Network Analysis. Semin Oncol Nurs. 2024 Jun;40(3):151651. doi: 10.1016/j.soncn.2024.151651. Epub 2024 May 3.
- Zhou X, Lei C, Wei X, Dai W, Xu W, Ao Y, Li X, Qiao G, Shi Q. Patient's experiences of coughing after lung cancer surgery: A multicenter qualitative study. Cancer Med. 2024 Jan;13(2):e6993. doi: 10.1002/cam4.6993.
- Yang X, Bai J, Zhang J, Wang Y, Zhao H, Zhu X. Symptom clusters and their impacts on the quality of life of patients with lung cancer receiving immunotherapy: A cross-sectional study. J Clin Nurs. 2025 May;34(5):1725-1740. doi: 10.1111/jocn.17321. Epub 2024 Jun 17.
- Takemura N, Yorke J. Respiratory symptom cluster in people with lung cancer. Curr Opin Support Palliat Care. 2025 Jun 1;19(2):71-76. doi: 10.1097/SPC.0000000000000754. Epub 2025 Mar 19.
- Molassiotis A, Vu DV, Ching SSY. The Effectiveness of Qigong in Managing a Cluster of Symptoms (Breathlessness-Fatigue-Anxiety) in Patients with Lung Cancer: A Randomized Controlled Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211008253. doi: 10.1177/15347354211008253.
- Yorke J, Johnson MJ, Punnett G, Smith J, Blackhall F, Lloyd Williams M, Mackereth P, Haines J, Ryder D, Krishan A, Davies L, Khan A, Molassiotis A. Respiratory distress symptom intervention for non-pharmacological management of the lung cancer breathlessness-cough-fatigue symptom cluster: randomised controlled trial. BMJ Support Palliat Care. 2024 Jan 8;13(e3):e1181-e1190. doi: 10.1136/spcare-2022-003924.
- Karlsson K, Olsson C, Erlandsson A, Ahlberg KM, Larsson M. Exploring Symptom Clusters and Their Measurements in Patients With Lung Cancer: A Scoping Review for Practice and Research. Oncol Nurs Forum. 2023 Oct 19;50(6):783-815. doi: 10.1188/23.ONF.783-815.
- Cheville AL, Novotny PJ, Sloan JA, Basford JR, Wampfler JA, Garces YI, Jatoi A, Yang P. The value of a symptom cluster of fatigue, dyspnea, and cough in predicting clinical outcomes in lung cancer survivors. J Pain Symptom Manage. 2011 Aug;42(2):213-21. doi: 10.1016/j.jpainsymman.2010.11.005. Epub 2011 Mar 12.
- Molassiotis A, Lowe M, Blackhall F, Lorigan P. A qualitative exploration of a respiratory distress symptom cluster in lung cancer: cough, breathlessness and fatigue. Lung Cancer. 2011 Jan;71(1):94-102. doi: 10.1016/j.lungcan.2010.04.002. Epub 2010 May 2.
- Li Y, Wang Q, Liu C, Hu X. Symptom clusters and their impact on quality of life among Chinese patients with lung cancer: A cross-sectional study. Eur J Oncol Nurs. 2023 Dec;67:102465. doi: 10.1016/j.ejon.2023.102465. Epub 2023 Nov 7.
- Chen K, Yang D, Li F, Gao L, Tian Y, Xu B, Xu X, Xu Q, Cao J. Changes in the symptom clusters of elderly patients with lung cancer over the course of postoperative rehabilitation and their correlation with frailty and quality of life: A longitudinal study. Eur J Oncol Nurs. 2023 Dec;67:102388. doi: 10.1016/j.ejon.2023.102388. Epub 2023 Jul 24.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Respiratory Tract Diseases
- Lung Diseases
- Respiration Disorders
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Signs and Symptoms, Respiratory
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Syndrome
- Lung Neoplasms
- Disease
- Fatigue
- Cough
- Dyspnea
- Therapeutics
- Complementary Therapies
- Physical Therapy Modalities
- Socioeconomic Factors
- Population Characteristics
- Rehabilitation
- Therapy, Soft Tissue
- Musculoskeletal Manipulations
- Educational Status
- Acupressure
Other Study ID Numbers
- UW24615
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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