Clinical trial · Interventional
Effectiveness of A Multi-Component Self-Management Intervention for Anxiety and Respiratory-Related Symptoms in Patients With Lung Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| M-RDSI | Behavioral | — | UNRESOLVED |
| RDSI | Behavioral | — | UNRESOLVED |
| Usual Care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- RDSI
- interventionNames
- Behavioral: RDSI
- type
- EXPERIMENTAL
- label
- M-RDSI
- interventionNames
- Behavioral: M-RDSI
- type
- PLACEBO_COMPARATOR
- label
- Usual care
- interventionNames
- Behavioral: Usual Care
Primary outcomes (1)
- measure
- anxiety
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available