Mindfulness-based breathing program for respiratory distress in lung cancer

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

This trial will try a 6-week mindfulness-oriented breathing program plus usual care to see if it reduces breathlessness, cough, fatigue, anxiety, and depression for Cantonese-speaking adults with lung cancer in Hong Kong.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Hong Kong Polytechnic University (Academic / other)
• Locations: 1 site (Hong Kong)
• Trial ID: NCT07281300 on ClinicalTrials.gov

What this trial studies

The study uses a two-phase design that first co-develops and culturally adapts a mindfulness-oriented respiratory distress symptom intervention (M-RDSI) with input from patients and clinicians, then tests the intervention in a randomized trial. In Phase II, 64 participants will be randomized to receive 6 weeks of M-RDSI plus usual care or usual care alone, with a 12-week follow-up period. Outcomes include feasibility and acceptability (recruitment, retention, adherence, satisfaction), patient-reported symptom and psychological measures (breathlessness, cough, fatigue, mindfulness, anxiety, depression, quality of life), and neurophysiological measures including fMRI. Qualitative interviews and generalized estimating equation models will be used to explore participant experience and preliminary intervention effects.

Who should consider this trial

Good fit: Adults (18+) in Hong Kong who speak Cantonese, have a confirmed intrathoracic malignancy (including small cell, non-small cell, or mesothelioma), report breathlessness plus at least one other symptom (cough or fatigue), have WHO performance status 0–2, can undergo fMRI, and have an expected lifespan greater than six months.

Not a fit: Patients with significant cognitive impairment or severe psychosis, those already participating in mindfulness or other psychological/symptom-management programs, those unable to undergo fMRI, or those with very limited life expectancy or poor performance status are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the program could reduce respiratory symptoms and related anxiety or depression, improving overall quality of life and daily functioning for people with lung cancer.

How similar studies have performed: A multi-component Respiratory Distress Symptom Intervention (RDSI) developed in England showed clinical benefit for lung cancer symptoms but limited effects on psychological distress, while separate mindfulness interventions have shown promise for both symptom and psychological improvements, so this combined, culturally adapted approach builds on prior work but is relatively novel.

Eligibility criteria

Inclusion Criteria:

* HK patients who can understand Cantonese, aged 18 years or older;
* A confirmed diagnosis of an intrathoracic malignancy, including small cell lung cancer, non-small cell lung cancer, or mesothelioma; at any stage of cancer treatment or palliative care;
* Self-reported impact on daily life from at least two of the three symptoms, where one symptom is breathlessness;
* Stability of COPD, if present;
* WHO Performance Status of 0-2;
* fMRI can be conducted;
* Expected lifespan of more than six months.

Exclusion Criteria:

* Cognitive impairments, severe psychotic symptoms, or other medical conditions that might hinder participation;
* Participating in mindfulness or other psychological support interventions or symptom management interventions.

Where this trial is running

Hong Kong

• The Hong Kong Polytechnic University — Hong Kong, Hong Kong (Recruiting)

Study contacts

• Study coordinator: Yan LI

Conditions Symptom Cluster; Breathlessness; Coughing; Fatigue Symptom; Lung Cancer Patients; Brain Activity