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Mindfulness-Oriented Respiratory Distress Symptom Intervention for Lung Cancer

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary endpoints: details revised at 1 of 5 entries Show 8 more changesShow less
    • Enrollment closed, study ongoing
    • Primary completion moved earlier from Jun 30, 2027 to Nov 30, 2026
    • Study completion moved earlier from Jul 30, 2027 to Dec 30, 2026
    • Enrollment target: estimated 64 to confirmed 70
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 8 of 9 entries
    • Study description revised
    • Site details revised
  2. Minor Enrollment target: 50 to 64
    • Study description expanded, about 5 words
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07281300
Lead Sponsor The Hong Kong Polytechnic University
Conditions
(from sponsor)
Symptom Cluster, Breathlessness, Coughing, Fatigue Symptom, Lung Cancer Patients, Brain Activity
Related terms Cough, Dyspnea, Fatigue, Syndrome
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov