RecruitingNot ApplicableNCT07281300

Mindfulness-Oriented Respiratory Distress Symptom Intervention for Lung Cancer

Mindfulness-Oriented Respiratory Distress Symptom Intervention for Patients With Lung Cancer: A Feasibility Randomized Controlled Trial


Sponsor

The Hong Kong Polytechnic University

Enrollment

64 participants

Start Date

Aug 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Lung cancer is the leading cause of cancer mortality, posing a critical public health challenge in both Hong Kong and global populations. Patients with lung cancer frequently experience a distressing symptom cluster characterized by breathlessness-driven respiratory distress, accompanied by persistent cough and fatigue, which collectively impose a substantial disease burden. While our research team leader previously developed and validated a multi-component Respiratory Distress Symptom Intervention (RDSI) in England, demonstrating clinical efficacy for lung cancer management, its impact on psychological distress (anxiety and depression) proved limited. This limitation may reflect insufficient integration of psychological components, a crucial consideration given the well-established bidirectional relationship between respiratory symptoms and psychological distress. Emerging evidence indicates that mindfulness interventions provide dual therapeutic benefits by improving patient adherence and effectively addressing both physical symptoms, such as breathlessness and fatigue, as well as psychological distress, including anxiety and depression. Meanwhile, current evaluation methodologies have mainly focused on behavioral data collection, such as self-reported questionnaires, to reflect the effect before and after the intervention. Neuroimaging data can help understand the brain mechanisms underlying breathlessness and elucidate the effectiveness of interventions, thereby improving intervention strategies.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a mindfulness-based program to help lung cancer patients manage three common and distressing symptoms: breathlessness, fatigue, and pain. Researchers want to see if this approach improves quality of life and changes brain activity. **You may be eligible if...** - You live in Hong Kong and can understand Cantonese - You are 18 or older - You have been diagnosed with lung cancer (including small cell, non-small cell, or mesothelioma) at any stage - At least two of the following bother your daily life: breathlessness, fatigue, or pain — and one of them must be breathlessness - Your doctor rates your ability to carry out daily activities as fairly good (WHO Performance Status 0–2) - You are expected to live more than six months - You are able to undergo a brain MRI scan **You may NOT be eligible if...** - You have significant cognitive difficulties, severe psychiatric symptoms, or other conditions that would prevent participation - You are currently enrolled in another mindfulness, psychological support, or symptom management program Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMindfulness-Oriented Respiratory Distress Symptom Intervention (M-RDSI)

Patients in the M-RDSI group will receive a 6-week intervention and begin with a training session (ideally face-to-face at the cancer center or the research center or an online meeting as backup for around 60 minutes, including 1) mindfulness training, such as mindful breathing and relaxation; 2) controlled breathing techniques, cough suppression techniques, acupressure, and exercise; and 3) using mindful breathing, relaxation, and attitudes to orientate the practice of RDSI. A second group training session will be conducted 3 weeks later to review the intervention and discuss any questions participants may have. The training sessions will be delivered by a well-trained research assistant from experienced clinicians and the research team. Participants will be guided by the M-RDSI web-based educational materials (e.g., text, pictures, and videos) and a detailed intervention manual for their daily home practice.

OTHERUsual Care

Usual care will receive health educational booklets, including brief tips for symptom management designed by the research team, and routine follow-ups offered by the oncology nurse in the cancer center that patients with lung cancer usually receive.


Locations(1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

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NCT07281300


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