CancerNCT07782710
Effectiveness of A Multi-Component Self-Management Intervention for Anxiety and Respiratory-Related Symptoms in Patients With Lung Cancer
A study testing M-RDSI and RDSI in people with Cancer, run by The Hong Kong Polytechnic University.
Trial summary
The study aims to examine the effectiveness of M-RDSI (Mindfulness-Respiratory Distress Symptom Intervention) in Hong Kong (HK) Chinese patients with lung cancer (LC). Investigators will conduct a three-arm mixed-methods randomized controlled trial (RCT) involving 189 patients with LC.The three groups are M-RDSI, RDSI… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- M-RDSI and RDSI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 189 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Jan 2030
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) HK residents who understand Cantonese, 18 years or older;
- 2) diagnosed intrathoracic malignancy (small/non-small cell LC, secondary LC, mesothelioma); receiving cancer treatment or palliative care;
- 3) self-report presence of at least two of the three respiratory-related symptoms (breathlessness/cough/fatigue), AND one symptom is breathlessness. Patients screened as per original RDSI and HK pilot study, by asking (i) do you have breathlessness/cough/fatigue, if 'yes', (ii) is your daily life impacted by breathlessness/cough/fatigue?
- 4) at least moderate level of anxiety (STAI-State score ≥ 38) (primary outcome);
- 5) WHO Performance Status of 0-2.
Who cannot join
- 1) acute exacerbation of COPD/chest infection within past 4 weeks that necessitated a change in medication,
- 2) received radiotherapy to the chest in previous 4 weeks, or surgical treatment for LC in previous 6 weeks.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of A Multi-Component Self-Management Intervention for Anxiety and Respiratory-Related Symptoms in Patients With Lung Cancer: A 3-Arm Randomized Controlled Trial
The study aims to examine the effectiveness of M-RDSI (Mindfulness-Respiratory Distress Symptom Intervention) in Hong Kong (HK) Chinese patients with lung cancer (LC). Investigators will conduct a three-arm mixed-methods randomized controlled trial (RCT) involving 189 patients with LC.The three groups are M-RDSI, RDSI (Respiratory Distress Symptom Intervention), and usual care. The M-RDSI group includes standard RDSI training sessions, along with four additional 30-minute sessions dedicated to practicing core exercises from MBCT. These sessions are facilitated by a trained nurse and will be held at the hospital or PolyU, depending on the participants' preferences. The RDSI group will receive four evidence-based components at the hospital or PolyU, depending on the participants' preferences. The usual care group will receive health educational booklets based on the original RDSI materials, which have been adapted for HK LC patients.The study will be conducted at Chinese University of HK, Prince of Wales Hospital. Data collection will be conducted at baseline, week 6, and week 12 after the completion of the intervention. Multiple assessment timepoints will capture changes over time.
- Conditions
- Cancer
- Being tested
- M-RDSI, RDSI, Usual Care
- Keywords
- Lung cancer patients, Anxiety, Respiratory-related symptoms, Mindfulness-based cognitive therapy, Respiratory distress symptom intervention
- Medical subject headings
- Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-RDSIBehavioural
The M-RDSI group includes standard RDSI training sessions, along with four additional 30-minute sessions dedicated to practicing core exercises from MBCT. These sessions are facilitated by a trained nurse and will be held at the hospital or PolyU, depending on the participants' preferences. For the mindfulness component, four techniques will be taught, which include 'mindful breathing', 'automatic pilot' exercise, 'thoughts are not the facts' exercise, and 'body scan meditation'. The M-RDSI group will also be advised to practice the mindfulness skills when feeling anxious. Participants will be requested to complete an intervention adherence diary and provided with access to the relevant online materials already adapted for HK patients with LC.
RDSIBehavioural
The RDSI group contains four evidence-based components: (1) controlled diaphragmatic breathing exercises and calming techniques, (2) cough easing techniques which educate patients to identify warning signs of cough and to apply modified swallow techniques or relaxed throat breathing, (3) acupressure with self-applied pressure for 1 minute on acupressure points: L7, L9 and L14 (hand/wrist areas), CV21 and 22 (sternum) and ST36 (knee)), and (4) tips for increasing activity levels. Participants will be requested to complete an intervention adherence diary and provided with access to the relevant online materials already adapted for HK patients with LC.
Usual CareBehavioural
The Usual care group will receive health educational booklets including brief tips for symptom management based on original RDSI materials and adapted with HK LC patients.
| Study group | Role | What they receive |
|---|---|---|
| RDSI | Active comparator | Not described Receives: Behavioral: RDSI |
| M-RDSI | Experimental | Not described Receives: Behavioral: M-RDSI |
| Usual care | Placebo comparator | Not described Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiety
Chinese version of the state-anxiety form of the State-Trait Anxiety Inventory (STAI-Y) with 20 items, total scores range from 20 to 80; higher scores represent higher state-anxiety levels. Scores are classified: 20-37 as mild, 38-44 as moderate and 45-80 as high. The Chinese version of the STAI is validated in the Chinese population.
Measured: Baseline, Week 6, and Week 12
Secondary outcomes (5)
breathlessness
All participants will use Dyspnoea-12 to collect data on breathlessness.
Measured: Baseline, Week 6, and Week 12
cough
All participants will use the Leicester Cough Questionnaire to collect data on cough.
Measured: baseline, week 6, and week 12
fatigue
All participants will use the Functional Assessment of Chronic Illness Therapy-Fatigue to collect data on fatigue.
Measured: baseline, week 6, and week 12
mindfulness
All participants will use the Mindful Attention Awareness Scale to collect data on mindfulness.
Measured: baseline, week 6, and week 12
HRQoL
All participants will use the EuroQoL 5-Dimension 5-Level to collect data on HRQoL.
Measured: baseline, week 6, and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Research Grants Council, Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong
- Responsible party
- Principal investigator, Dr Eva Ho, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782710
- Sponsor's protocol ID
- Self-management intervention
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of A Multi-Component Self-Management Intervention for Anxiety and Respiratory-Related Symptoms in Patients With Lung Cancer: A 3-Arm Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07782710
- Acronym / sponsor ID
- Self-management intervention
- Conditions
- Cancer
- Keywords
- Lung cancer patients, Anxiety, Respiratory-related symptoms, Mindfulness-based cognitive therapy, Respiratory distress symptom intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Research Grants Council, Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 24 Aug 2026 (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.
The study aims to examine the effectiveness of M-RDSI (Mindfulness-Respiratory Distress Symptom Intervention) in Hong Kong (HK) Chinese patients with lung cancer (LC). Investigators will conduct a three-arm mixed-methods randomized controlled trial (RCT) involving 189 patients with LC.The three groups are M-RDSI, RDSI (Respiratory Distress Symptom Intervention), and usual care. The M-RDSI group includes standard RDSI training sessions, along with four additional 30-minute sessions dedicated to practicing core exercises from MBCT. These sessions are facilitated by a trained nurse and will be held at the hospital or PolyU, depending on the participants' preferences. The RDSI group will receive four evidence-based components at the hospital or PolyU, depending on the participants' preferences. The usual care group will receive health educational booklets based on the original RDSI materials, which have been adapted for HK LC patients.The study will be conducted at Chinese University of HK, Prince of Wales Hospital. Data collection will be conducted at baseline, week 6, and week 12 after the completion of the intervention. Multiple assessment timepoints will capture changes over time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RDSI | Active comparator | Behavioral: RDSI |
| M-RDSI | Experimental | Behavioral: M-RDSI |
| Usual care | Placebo comparator | Behavioral: Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1) HK residents who understand Cantonese, 18 years or older;
- 2) diagnosed intrathoracic malignancy (small/non-small cell LC, secondary LC, mesothelioma); receiving cancer treatment or palliative care;
- 3) self-report presence of at least two of the three respiratory-related symptoms (breathlessness/cough/fatigue), AND one symptom is breathlessness. Patients screened as per original RDSI and HK pilot study, by asking (i) do you have breathlessness/cough/fatigue, if 'yes', (ii) is your daily life impacted by breathlessness/cough/fatigue?
- 4) at least moderate level of anxiety (STAI-State score ≥ 38) (primary outcome);
- 5) WHO Performance Status of 0-2.
Key exclusion criteria (2 listed)
- 1) acute exacerbation of COPD/chest infection within past 4 weeks that necessitated a change in medication,
- 2) received radiotherapy to the chest in previous 4 weeks, or surgical treatment for LC in previous 6 weeks.
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 |
|---|---|---|
| M-RDSIThe M-RDSI group includes standard RDSI training sessions, along with four additional 30-minute sessions dedicated to practicing core exercises from MBCT. These sessions are facilitated by a trained nurse and will be held at the hospital or PolyU, depending on the participants' preferences. For the mindfulness component, four techniques will be taught, which include 'mindful breathing', 'automatic pilot' exercise, 'thoughts are not the facts' exercise, and 'body scan meditation'. The M-RDSI group will also be advised to practice the mindfulness skills when feeling anxious. Participants will be requested to complete an intervention adherence diary and provided with access to the relevant online materials already adapted for HK patients with LC. | Behavioural | M-RDSI |
| RDSIThe RDSI group contains four evidence-based components: (1) controlled diaphragmatic breathing exercises and calming techniques, (2) cough easing techniques which educate patients to identify warning signs of cough and to apply modified swallow techniques or relaxed throat breathing, (3) acupressure with self-applied pressure for 1 minute on acupressure points: L7, L9 and L14 (hand/wrist areas), CV21 and 22 (sternum) and ST36 (knee)), and (4) tips for increasing activity levels. Participants will be requested to complete an intervention adherence diary and provided with access to the relevant online materials already adapted for HK patients with LC. | Behavioural | RDSI |
| Usual CareThe Usual care group will receive health educational booklets including brief tips for symptom management based on original RDSI materials and adapted with HK LC patients. | Behavioural | Usual care |
Primary outcome
anxiety
Time frame: Baseline, Week 6, and Week 12
Chinese version of the state-anxiety form of the State-Trait Anxiety Inventory (STAI-Y) with 20 items, total scores range from 20 to 80; higher scores represent higher state-anxiety levels. Scores are classified: 20-37 as mild, 38-44 as moderate and 45-80 as high. The Chinese version of the STAI is validated in the Chinese population.
5 secondary outcomes
breathlessness
Time frame: Baseline, Week 6, and Week 12
cough
Time frame: baseline, week 6, and week 12
fatigue
Time frame: baseline, week 6, and week 12
mindfulness
Time frame: baseline, week 6, and week 12
HRQoL
Time frame: baseline, week 6, and week 12
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 24 Aug 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing M-RDSI and RDSI in people with Cancer, run by The Hong Kong Polytechnic University.
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 5 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: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Contact Ka Yan Ho (+8527666417, kyeva.ho@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anxiety (time frame: Baseline, Week 6, and Week 12). 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 24 Aug 2026.