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

NCT07782710 | Not Yet Recruiting

• 1 other identifier: Self-management intervention
• Study Type: interventional
• Target: 189
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cancer

Keywords

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

Outcome Measures

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.

  Baseline, Week 6, and Week 12

Secondary Outcomes (5)

• breathlessness

  Baseline, Week 6, and Week 12

• cough

  baseline, week 6, and week 12

• fatigue

  baseline, week 6, and week 12

• mindfulness

  baseline, week 6, and week 12

• HRQoL

  baseline, week 6, and week 12

Other Outcomes (1)

• Health care utilization

  baseline, week 6, and week 12

Study Arms (3)

RDSI

ACTIVE COMPARATOR

Behavioral: RDSI

M-RDSI

EXPERIMENTAL

Behavioral: M-RDSI

Usual care

PLACEBO COMPARATOR

Behavioral: Usual Care

Interventions

M-RDSI BEHAVIORAL

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.

M-RDSI

RDSI BEHAVIORAL

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.

RDSI

Usual Care BEHAVIORAL

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.

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) HK residents who understand Cantonese, 18 years or older;
• \) diagnosed intrathoracic malignancy (small/non-small cell LC, secondary LC, mesothelioma); receiving cancer treatment or palliative care;
• \) 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?
• \) at least moderate level of anxiety (STAI-State score ≥ 38) (primary outcome);
• \) WHO Performance Status of 0-2.

You may not qualify if:

• \) acute exacerbation of COPD/chest infection within past 4 weeks that necessitated a change in medication,
• \) received radiotherapy to the chest in previous 4 weeks, or surgical treatment for LC in previous 6 weeks.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Research Grants Council, Hong Kong: collaborator
• Prince of Wales Hospital, Shatin, Hong Kong: collaborator

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Ka Yan Ho

CONTACT

+8527666417; kyeva.ho@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: August 24, 2026

Record last verified: 2026-08