Effectiveness of A Multi-Component Self-Management Intervention for Anxiety and Respiratory-Related Symptoms in Patients With Lung Cancer
20 de agosto de 2026 actualizado por: Dr Eva Ho, The Hong Kong Polytechnic University
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
189
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Ka Yan Ho
- Número de teléfono: +8527666417
- Correo electrónico: kyeva.ho@polyu.edu.hk
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador de placebos: Cuidado usual
|
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.
|
|
Comparador activo: 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
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
anxiety
Periodo de tiempo: 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.
|
Baseline, Week 6, and Week 12
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
breathlessness
Periodo de tiempo: Baseline, Week 6, and Week 12
|
All participants will use Dyspnoea-12 to collect data on breathlessness.
|
Baseline, Week 6, and Week 12
|
|
cough
Periodo de tiempo: baseline, week 6, and week 12
|
All participants will use the Leicester Cough Questionnaire to collect data on cough.
|
baseline, week 6, and week 12
|
|
fatigue
Periodo de tiempo: baseline, week 6, and week 12
|
All participants will use the Functional Assessment of Chronic Illness Therapy-Fatigue to collect data on fatigue.
|
baseline, week 6, and week 12
|
|
mindfulness
Periodo de tiempo: baseline, week 6, and week 12
|
All participants will use the Mindful Attention Awareness Scale to collect data on mindfulness.
|
baseline, week 6, and week 12
|
|
HRQoL
Periodo de tiempo: baseline, week 6, and week 12
|
All participants will use the EuroQoL 5-Dimension 5-Level to collect data on HRQoL.
|
baseline, week 6, and week 12
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Health care utilization
Periodo de tiempo: baseline, week 6, and week 12
|
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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de enero de 2027
Finalización primaria (Estimado)
1 de enero de 2030
Finalización del estudio (Estimado)
1 de enero de 2030
Fechas de registro del estudio
Enviado por primera vez
20 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
20 de agosto de 2026
Publicado por primera vez (Actual)
24 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
20 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Self-management intervention
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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