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

50 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

Inclusion Criteria7

  • 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 Criteria2

  • 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.

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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