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

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 Overview

• Status: Not yet recruiting
• Conditions: Cancer
• Intervention / Treatment: Behavioral: RDSI; Behavioral: M-RDSI; Behavioral: Usual Care

• Study Type: Interventional
• Enrollment (Estimated): 189
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ka Yan Ho; Phone Number: +8527666417; Email: kyeva.ho@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Usual care	Behavioral: Usual 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.
Active Comparator: RDSI	Behavioral: RDSI; 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.
Experimental: M-RDSI	Behavioral: M-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 6, and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
breathlessness	All participants will use Dyspnoea-12 to collect data on breathlessness.	Baseline, Week 6, and Week 12
cough	All participants will use the Leicester Cough Questionnaire to collect data on cough.	baseline, week 6, and week 12
fatigue	All participants will use the Functional Assessment of Chronic Illness Therapy-Fatigue to collect data on fatigue.	baseline, week 6, and week 12
mindfulness	All participants will use the Mindful Attention Awareness Scale to collect data on mindfulness.	baseline, week 6, and week 12
HRQoL	All participants will use the EuroQoL 5-Dimension 5-Level to collect data on HRQoL.	baseline, week 6, and week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline, week 6, and week 12

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: Prince of Wales Hospital, Shatin, Hong Kong; Research Grants Council, Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: August 20, 2026
• First Submitted That Met QC Criteria: August 20, 2026
• First Posted (Actual): August 24, 2026

Study Record Updates

• Last Update Posted (Actual): August 24, 2026
• Last Update Submitted That Met QC Criteria: August 20, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Anxiety; Mindfulness-based cognitive therapy; Lung cancer patients; Respiratory-related symptoms; Respiratory distress symptom intervention
• Additional Relevant MeSH Terms: Mental Disorders; Neoplasms; Anxiety Disorders
• Other Study ID Numbers: Self-management intervention

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No