NCT03223805

Respiratory Distress Symptom Intervention (RDSI) Trial

A Randomised Controlled Trial to Determine the Clinical and Cost Effectiveness of the Respiratory Distress Symptom Intervention for People With Lung Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 263 (actual)
• Sponsor: The Christie NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to determine the effects of adding the Respiratory Distress Symptom Intervention (RDSI) to usual care for the self management of the Respiratory Distress Symptom Cluster (breathlessness-cough-fatigue) for patients with lung cancer including mesothelioma.

Detailed description

Lung cancer is responsible for 33,000 deaths each year in the UK and as disease cure is rarely possible, patient management is often aimed at symptom control. Breathlessness, cough and fatigue are common and distressing symptoms occurring in up to 90%, 47-86% and 50-90% of patients respectively. To date, research in relation to this group of symptoms has focussed on breathlessness, cough or fatigue as single symptoms. However, it is likely that ifa patient suffers from one symptom, they also suffer from one or both of the others. Collectively these symptoms are referred to as the Respiratory Distress Symptom Cluster. Our group has developed a multi-modal Respiratory Distress Symptom Intervention (RDSI) for the self management of breathlessness, cough and fatigue. This study aims to determine the effects of adding the RDSI to usual care for the self-management of the Respiratory Distress Symptom Cluster for patients with lung cancer. Patients who take part will be assigned to one of two groups; usual care or usual care plus the RDSI.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
OTHER	Respiratory Distress Symptom Intervention	The RDSI comprises of four components 1. Controlled breathing techniques - consists of diaphragmatic breathing exercises and calming techniques practised twice a day and used as needed for episodes of intense breathlessness and/or anxiety 2. Cough suppression techniques - includes education (capacity for voluntary cough easing, identifying warning signs for cough and replace with modified swallow technique or relaxed throat breath 3. Acupressure: a small number of acupressure points are taught: L7, L9, LI4 (located on the hand and wrist areas), CV21 and 22 (sternum), and ST36 (knee). Patients can select any of these points in any combination to apply pressure for one-minute at least twice a day for symptom relief 4. Exercise: Individually-tailored exercise plan, for example, walking incrementally increasing distances in their local environment, incorporating breathing techniques as required

Timeline

• Start date: 2017-04-04
• Primary completion: 2019-09-30
• Completion: 2019-09-30
• First posted: 2017-07-21
• Last updated: 2021-12-10

Locations

7 sites across 1 country: United Kingdom