Acupressure for Cough in Lung Cancer Survivors

Официальное название

Acupressure for Cough in Lung Cancer Survivors: A Randomized Controlled Trial

Обзор

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).

Подробное описание

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.

Вмешательства

• Поведенческое acupressure
  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.
• Другое Education
  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.

Первичные конечные точки

• Cough [Срок оценки: 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)]

Вторичные конечные точки (7)

• Cough-related quality of life [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Pre-intervention (T0, baseline); Post-intervention (T2, 8 weeks after T0); Follow-up (T3, 16 weeks after T0)]
• Health-related quality of life [Срок оценки: 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)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 1 центр

• University of Hong Kong-Shenzhen Hospital — Шэньчжэнь

Гонконг · 1 центр

• Queen Mary Hospital — Гонконг

Публикации

• 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. PMID 38704342
• 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. PMID 38348918
• 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. PMID 38886988
• 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. PMID 40265563
• 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. PMID 33847150
• 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 PMID 36283797
• 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. PMID 37874760
• 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. PMID 21398089

Идентификаторы

NCT: NCT07315672 · UW24615

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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