Acupressure for Cough in Lung Cancer Survivors

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong

About this 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:

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • acupressure

    Behavioral

    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.

  • Education

    Other intervention

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: AcupressureExperimental treatment 1 intervention
Group B: EducationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cough

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.

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)

Secondary outcomes

1

Cough-related quality of life

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.

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)
2

Dyspnea-cough-fatigue symptom cluster

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).

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)
3

Dyspnea

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).

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)
4

Fatigue

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.

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)

Other outcomes

Sponsors and contacts

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The University of Hong Kong

Lead sponsor

The University of Hong Kong-Shenzhen Hospital

Collaborator

Queen Mary Hospital, Hong Kong

Collaborator