Mindfulness-Oriented Respiratory Distress Symptom Intervention for Lung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Hong Kong Polytechnic University
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Mindfulness-Oriented Respiratory Distress Symptom Intervention (M-RDSI)
BehavioralPatients 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.
Usual Care
Other interventionUsual 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.
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: Mindfulness-Oriented Respiratory Distress Symptom Intervention (M-RDSI)Experimental treatment 1 intervention
Group B: Usual careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment rate
The recruitment rate will be calculated as the percentage of eligible participants who enroll in the study out of the total number of eligible participants.
Time frame
Baseline2
Retention rate
The retention rate will be calculated as the percentage of participants who completed the entire research process (including the follow-up) out of the initial recruitment number.
Time frame
Immediately after intervention and at 12-weeks follow-up3
Drop-out rate
The drop-out rate will be calculated as the percentage of participants who voluntarily withdrew from the study out of the initial recruitment number.
Time frame
Immediately after intervention and at 12-weeks follow-up4
Adherence rate
The adherence rate will be calculated as the percentage of participants who complete the 6-week intervention.
Time frame
Immediately after interventionSecondary outcomes
1
Breathlessness
This will be measured by the Dyspnoea-12. Participants will be asked to rate 12 items, with each item scored on a scale from 0 to 3. The total score ranges from 0 to 36, with higher scores indicating more severe symptoms of breathlessness.
Time frame
Baseline, immediately after intervention, and at 12-weeks follow-up2
Breathlessness expectation
This will be measured by the Breathlessness word cue set. Participants will be asked to rate 23 items using two Visual Analogue Scales: one for breathlessness and the other for breathlessness-anxiety. Each item ranges from 0% to 100%, with higher scores indicating greater levels of breathlessness or breathlessness-anxiety.
Time frame
Baseline, immediately after intervention, and at 12-weeks follow-up3
Cough
This will be measured by the Leicester Cough Questionnaire. Participants will be asked to rate 19 items, each scored on a scale from 1 to 7. The total score is calculated by converting the item scores, yielding a possible range from 3 to 21, with higher scores indicating less severe cough symptoms.
Time frame
Baseline, immediately after intervention, and at 12-weeks follow-up4
Fatigue
This will be measured by the Functional Assessment of Chronic Illness Therapy-Fatigue. Participants will be asked to rate 13 items, each scored on a five-point Likert scale from 0 to 4. The total score ranges from 0 to 52, with higher scores indicating less severe fatigue symptoms.
Time frame
Baseline, immediately after intervention, and at 12-weeks follow-upSponsors and contacts
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Source ClinicalTrials.gov