Acupressure, Coughing, Lung Cancer (Diagnosis), Symptom Cluster
Conditions
Keywords
Acupressure, Cough, Lung Cancer, Dyspnea, Symptom Cluster, Symptom Burden, Fatigue, Quality of Life
Brief summary
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: 1. Acupressure can alleviate cough in lung cancer survivors; 2. Acupressure can reduce a cough-related symptom cluster (dyspnea-cough-fatigue) experienced by lung cancer survivors; 3. 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).
Detailed description
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.
Interventions
BEHAVIORALacupressure
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.
OTHEREducation
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.
Sponsors
The University of Hong Kong
The University of Hong Kong-Shenzhen Hospital
Queen Mary Hospital, Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cough | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| 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) | 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). |
| 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) | 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). |
| 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) | 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. |
| 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) | 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. |
| Functional capacity | Pre-intervention (T0, baseline); Post-intervention (T2, 8 weeks after T0); Follow-up (T3, 16 weeks after T0) | Functional capacity will be assessed using the 6-minute Walking Test (6MWT), a valid and widely used test among patients with respiratory diseases. |
| 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) | 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. |
Countries
China, Hong Kong
Contacts
CONTACTMengyao Cao
STUDY_DIRECTORDenise Shuk Ting Cheung, PhD
The University of Hong Kong
Outcome results
None listed