Mindfulness-Oriented Respiratory Distress Symptom Intervention for Lung Cancer

April 14, 2026 updated by: The Hong Kong Polytechnic University

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study aims to develop and evaluate a mindfulness-oriented respiratory distress symptom intervention (M-RDSI) for patients with lung cancer. This study uses a two-phase experimental design to develop the M-RDSI and to evaluate the M-RDSI intervention's clinical and neurophysiological effects. In Phase I, the aim is to develop and content-validate the M-RDSI, including cultural adaptation adjustment and co-design of the M-RDSI intervention, including intervention teaching materials, through an expert panel consisting of patients with lung cancer and healthcare professionals. In Phase II, sixty-four participants will be randomized into the intervention group, receiving a 6-week M-RDSI intervention in addition to usual care followed by a 12-week follow-up, or the control group, which will receive usual care during the same period. During Phase IIa, the feasibility, acceptability, and preliminary clinical outcomes will be evaluated. Feasibility will be assessed through recruitment, dropout, and retention rates. Acceptability will be measured by treatment adherence rates and participant satisfaction, gathered through qualitative interviews. Preliminary clinical effectiveness will include self-reported outcomes such as breathlessness, cough, fatigue, mindfulness, anxiety, depression, and quality of life. The generalized estimating equation will be employed to analyze the intervention effects. Additionally, one-on-one qualitative interviews will be conducted post-intervention to gather participants' feedback on the perceived effectiveness, acceptability, strengths, limitations, and suggestions for improving the M-RDSI program. In Phase IIb, a task-based fMRI will be conducted at baseline and post-intervention, using a set of breathlessness-related word cues as stimuli to assess changes in brain activity. Analysis will be corrected for multiple comparisons. A general linear model will be constructed for the first-level fMRI analysis. A 2-by-2 factorial ANOVA will assess the group-by-time interaction of brain activity, and a paired t-test will evaluate pre- and post-treatment changes within the intervention group for the group analysis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Mindfulness-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.
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.
Other: Usual 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: Baseline
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
Time Frame: Immediately after intervention and at 12-weeks follow-up
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
Time Frame: Immediately after intervention and at 12-weeks follow-up
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
Time Frame: Immediately after intervention
The adherence rate will be calculated as the percentage of participants who complete the 6-week intervention.
Immediately after intervention
Participants' satisfaction
Time Frame: At 12-weeks follow-up
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Breathlessness
Time Frame: Baseline, immediately after intervention, and at 12-weeks follow-up
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.
Baseline, immediately after intervention, and at 12-weeks follow-up
Breathlessness expectation
Time Frame: Baseline, immediately after intervention, and at 12-weeks follow-up
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.
Baseline, immediately after intervention, and at 12-weeks follow-up
Cough
Time Frame: Baseline, immediately after intervention, and at 12-weeks follow-up
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.
Baseline, immediately after intervention, and at 12-weeks follow-up
Fatigue
Time Frame: Baseline, immediately after intervention, and at 12-weeks follow-up
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.
Baseline, immediately after intervention, and at 12-weeks follow-up
Mindfulness
Time Frame: Baseline, immediately after intervention, and at 12-weeks follow-up
This will be measured by the Mindful Attention Awareness Scale. Participants will be asked to rate 15 items, each scored on a six-point Likert scale from 1 to 6. The overall score is obtained by averaging the scores of all items, with higher mean scores indicating a greater level of mindfulness.
Baseline, immediately after intervention, and at 12-weeks follow-up
Depression
Time Frame: Baseline, immediately after intervention, and at 12-weeks follow-up
This will be measured by the Center for Epidemiologic Studies Depression Scale. Participants will be asked to rate 20 items, each scored on a four-point Likert scale from 0 to 3. The total score ranges from 0 to 60, with higher scores indicating more severe depressive symptoms.
Baseline, immediately after intervention, and at 12-weeks follow-up
Anxiety
Time Frame: Baseline, immediately after intervention, and at 12-weeks follow-up
This will be measured by the State-Trait Anxiety Inventory, which consists of two subscales: the State Anxiety Scale and the Trait Anxiety Scale. Each subscale contains 20 items, with each item scored on a four-point Likert scale from 1 to 4. The total score for each subscale ranges from 20 to 80, with higher scores indicating greater levels of state or trait anxiety.
Baseline, immediately after intervention, and at 12-weeks follow-up
Quality of life (QoL)
Time Frame: Baseline, immediately after intervention, and at 12-weeks follow-up
This will be measured by the EuroQoL 5-Dimension 5-Level. Participants will be asked to rate five domains-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each on a five-level scale ranging from no problems to extreme problems. Participants will also be asked to provide an overall assessment of their health using a visual analogue scale from 0 to 100, with higher visual analogue scale scores indicating better quality of life.
Baseline, immediately after intervention, and at 12-weeks follow-up
Breathlessness expectation-related brain activity
Time Frame: Baseline and immediately after intervention.
A task-based fMRI technology will be used to measure breathlessness expectation using a breathlessness word cue set.
Baseline and immediately after intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 12, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSEARS20250424001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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