ClinicalTrials.gg
Not yet recruitingNCT07782710Updated Aug 24, 2026

Effectiveness of A Multi-Component Self-Management Intervention for Anxiety and Respiratory-Related Symptoms in Patients With Lung Cancer

An interventional study of M-RDSI and RDSI in Cancer, sponsored by The Hong Kong Polytechnic University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
189
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 (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.

02

Conditions studied

  • Cancer

Keywords

  • Lung cancer patients
  • Anxiety
  • Respiratory-related symptoms
  • Mindfulness-based cognitive therapy
  • Respiratory distress symptom intervention
03

In context

Neoplasms

10,822 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's planned enrollment of 189 is above the median of 60 across 7,704 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

The Hong Kong Polytechnic University is the lead sponsor of 681 studies on the registry; 259 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1) HK residents who understand Cantonese, 18 years or older;
  • 2) diagnosed intrathoracic (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) of 0-2.

Exclusion criteria

Exclusion Criteria:

  • 1) acute exacerbation of /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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
189 participants (estimated)

Study arms

  • Active comparator
    RDSI

    Behavioral: RDSI

  • Experimental
    M-RDSI

    Behavioral: M-RDSI

  • Placebo comparator
    Usual care

    Behavioral: Usual Care

Interventions

  • BehavioralM-RDSI

    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.

  • BehavioralRDSI

    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.

  • BehavioralUsual Care

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, Week 6, and Week 12

Secondary outcomes

  1. breathlessness

    All participants will use Dyspnoea-12 to collect data on breathlessness.

    Time frame: Baseline, Week 6, and Week 12

  2. cough

    All participants will use the Leicester Cough Questionnaire to collect data on cough.

    Time frame: baseline, week 6, and week 12

  3. fatigue

    All participants will use the Functional Assessment of Chronic Illness Therapy-Fatigue to collect data on fatigue.

    Time frame: baseline, week 6, and week 12

  4. mindfulness

    All participants will use the Mindful Attention Awareness Scale to collect data on mindfulness.

    Time frame: baseline, week 6, and week 12

  5. HRQoL

    All participants will use the EuroQoL 5-Dimension 5-Level to collect data on HRQoL.

    Time frame: baseline, week 6, and week 12

Other outcomes

  1. Health care utilization

    All participants will use planned day-hospital or hospital overnight stays, hospital emergency visits and admissions (per night), GP and other community service visits to collect data on health resource.

    Time frame: baseline, week 6, and week 12

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2027; primary completion for Jan 2030, 36 months later.

Of 1,983 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's planned 36 months is above that.

Counting every sponsor, half of 2,058 studies reached it within 29 months; a quarter within 13 and three quarters within 52.

Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 20, 2026
First posted
Aug 24, 2026
StartEst.
Jan 1, 2027
Primary completionEst.
Jan 1, 2030
CompletionEst.
Jan 1, 2030
Last update
Aug 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07782710
Collaborators
Research Grants Council, Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong
Responsible party
Dr Eva Ho (Associate Professor, The Hong Kong Polytechnic University) — Principal investigator
First posted
Aug 24, 2026
Start date
Jan 1, 2027 (estimated)
Primary completion
Jan 1, 2030 (estimated)
Completion
Jan 1, 2030 (estimated)
Last update
Aug 24, 2026

Study contacts

Ka Yan Ho
Contact
kyeva.ho@polyu.edu.hk
+8527666417

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion