Mindfulness-Oriented Respiratory Distress Symptom Intervention for Lung Cancer

NCT07281300 | Recruiting

• 1 other identifier: HSEARS20250424001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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.

  Baseline

• 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.

  Immediately after intervention and at 12-weeks follow-up

• 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.

  Immediately after intervention and at 12-weeks follow-up

• Adherence rate

  The adherence rate will be calculated as the percentage of participants who complete the 6-week intervention.

  Immediately after intervention

• Participants' satisfaction

  The participants' satisfaction will be assessed through one-to-one interviews by well-trained PhD students or research assistants.

  At 12-weeks follow-up

Secondary Outcomes (9)

• Breathlessness

  Baseline, immediately after intervention, and at 12-weeks follow-up

• Breathlessness expectation

  Baseline, immediately after intervention, and at 12-weeks follow-up

• Cough

  Baseline, immediately after intervention, and at 12-weeks follow-up

• Fatigue

  Baseline, immediately after intervention, and at 12-weeks follow-up

• Mindfulness

  Baseline, immediately after intervention, and at 12-weeks follow-up

Study Arms (2)

Mindfulness-Oriented Respiratory Distress Symptom Intervention (M-RDSI)

EXPERIMENTAL

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.

Behavioral: Mindfulness-Oriented Respiratory Distress Symptom Intervention (M-RDSI)

Usual care

ACTIVE COMPARATOR

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.

Other: Usual Care

Interventions

Usual Care OTHER

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.

Usual care

Mindfulness-Oriented Respiratory Distress Symptom Intervention (M-RDSI) BEHAVIORAL

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.

Mindfulness-Oriented Respiratory Distress Symptom Intervention (M-RDSI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Syndrome; Dyspnea; Cough; Fatigue

Condition Hierarchy (Ancestors)

Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms

Central Study Contacts

Yan LI

CONTACT

2766 6388; yan-nursing.li@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants cannot be blinded due to the nature of the intervention. However, they will be instructed to maintain confidentiality and avoid discussing intervention details with other participants to minimize potential biases. The outcomes assessor who collects the participant's information will be blinded to the group allocation. However, the statistician responsible for quantitative data analysis will work with de-identified and de-grouped datasets to ensure blinding during the analysis phase.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: December 15, 2025
• Study Start: August 12, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: April 17, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)