Symptom ClusterNCT07281300
Mindfulness-Oriented Respiratory Distress Symptom Intervention for Lung Cancer
A study testing Mindfulness-Oriented Respiratory Distress Symptom Intervention (M-RDSI) in people with Symptom Cluster and Breathlessness, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Symptom Cluster, Breathlessness, Coughing
- What is being tested?
- Mindfulness-Oriented Respiratory Distress Symptom Intervention (M-RDSI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteHong Kong
- Study dates
- 12 Aug 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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, seventy 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.
- Conditions
- Symptom Cluster, Breathlessness, Coughing, Fatigue Symptom, Lung Cancer Patients, Brain Activity
- Being tested
- Mindfulness-Oriented Respiratory Distress Symptom Intervention (M-RDSI), Usual Care
- Medical subject headings
- Syndrome, Dyspnea, Cough, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Oriented Respiratory Distress Symptom Intervention (M-RDSI)Behavioural
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.
Usual CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately after intervention
Participants' satisfaction
The participants' satisfaction will be assessed through one-to-one interviews by well-trained PhD students or research assistants.
Measured: At 12-weeks follow-up
Secondary outcomes (9)
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.
Measured: Baseline, immediately after intervention, and at 12-weeks follow-up
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.
Measured: Baseline, immediately after intervention, and at 12-weeks follow-up
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.
Measured: Baseline, immediately after intervention, and at 12-weeks follow-up
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.
Measured: Baseline, immediately after intervention, and at 12-weeks follow-up
Mindfulness
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.
Measured: Baseline, immediately after intervention, and at 12-weeks follow-up
Depression
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.
Measured: Baseline, immediately after intervention, and at 12-weeks follow-up
Anxiety
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.
Measured: Baseline, immediately after intervention, and at 12-weeks follow-up
Quality of life (QoL)
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.
Measured: Baseline, immediately after intervention, and at 12-weeks follow-up
Breathlessness expectation-related brain activity
A task-based fMRI technology will be used to measure breathlessness expectation using a breathlessness word cue set.
Measured: Baseline and immediately after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start12 Aug 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptom ClusterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281300
- Sponsor's protocol ID
- HSEARS20250424001
- Status last verified
- Apr 2026
- First submitted
- 5 Jun 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Oriented Respiratory Distress Symptom Intervention for Patients With Lung Cancer: A Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07281300
- Acronym / sponsor ID
- HSEARS20250424001
- Conditions
- Symptom Cluster, Breathlessness, Coughing, Fatigue Symptom, Lung Cancer Patients, Brain Activity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, seventy 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Oriented Respiratory Distress Symptom Intervention (M-RDSI) | Experimental | Behavioral: 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. |
| Usual care | Active comparator | Other: Usual CareUsual 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Mindfulness-Oriented Respiratory Distress Symptom Intervention (M-RDSI) |
| Usual CareUsual 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. | Other | Usual care |
Primary outcome
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.
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.
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.
Adherence rate
Time frame: Immediately after intervention
The adherence rate will be calculated as the percentage of participants who complete the 6-week 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.
9 secondary outcomes
Breathlessness
Time frame: Baseline, immediately after intervention, and at 12-weeks follow-up
Breathlessness expectation
Time frame: Baseline, immediately after intervention, and at 12-weeks follow-up
Cough
Time frame: Baseline, immediately after intervention, and at 12-weeks follow-up
Fatigue
Time frame: Baseline, immediately after intervention, and at 12-weeks follow-up
Mindfulness
Time frame: Baseline, immediately after intervention, and at 12-weeks follow-up
Depression
Time frame: Baseline, immediately after intervention, and at 12-weeks follow-up
Anxiety
Time frame: 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
Breathlessness expectation-related brain activity
Time frame: Baseline and immediately after intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Oriented Respiratory Distress Symptom Intervention (M-RDSI) in people with Symptom Cluster and Breathlessness, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.