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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Hong Kong Special Administrative Region
The Hong Kong Polytechnic University
RECRUITING
Hong Kong
Contact Information
Primary
Yan LI
yan-nursing.li@polyu.edu.hk
2766 6388
Time Frame
Start Date: 2025-08-12
Estimated Completion Date: 2027-07-30
Participants
Target number of participants: 50
Treatments
Experimental: Mindfulness-Oriented Respiratory Distress Symptom Intervention (M-RDSI)
Patients in the M-RDSI group will receive a 6-week intervention, 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.
Active_comparator: Usual care
Usual care will receive health educational booklets and routine follow-ups offered by the oncology nurse in the cancer center that patients with lung cancer usually receive during the same 6 weeks.
Related Therapeutic Areas
Sponsors
Leads: The Hong Kong Polytechnic University

This content was sourced from clinicaltrials.gov