Respiratory Distress Symptom Intervention (RDSI) Trial

NCT ID: NCT03223805

Last Updated: 2021-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 263 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-04
• Study Completion Date: 2019-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control Arm

Usual Care

Group Type: OTHER

Respiratory Distress Symptom Intervention

Intervention Type: OTHER

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

Intervention Arm

Respiratory Distress Symptom Intervention plus Usual Care

Group Type: EXPERIMENTAL

Respiratory Distress Symptom Intervention

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. A diagnosis of lung cancer - primary tumour, secondary tumour or mesothelioma

2. Suffering from refractory breathlessness or cough or fatigue (presence of a minimum of two of the three symptoms), and which is bothersome to the patient (see below)*

3. In the presence of COPD, in stable condition

4. WHO Performance Status 0-2

5. Expected prognosis of at least 3 months

6. 18+ years

7. able to give informed consent

• Patients will be asked as part of the symptom screening process:

Are you affected in your day to day life by breathlessness? Are you affected in your day to day life by cough? Are you affected in your day to day life by fatigue?

Exclusion Criteria

1. Patients who are experiencing breathlessness, cough and/or fatigue but do not find these symptoms bothersome are not eligible (see below)*

2. Acute exacerbation** of COPD, or chest infection, within the past 3 weeks, necessitating a change in medication

3. Rapidly worsening breathlessness requiring urgent medical intervention

4. Post chemotherapy and/or radiotherapy to the chest > 2 weeks

5. Surgical treatment for lung cancer > 4 weeks

• Patients will be asked as part of the symptom screening process:

Are you affected in your day to day life by breathlessness? Are you affected in your day to day life by cough? Are you affected in your day to day life by fatigue?

** An exacerbation is defined as a sustained worsening of the patient's symptoms from their usual stable state which is beyond normal day-to-day variations, and is acute in onset. Commonly reported symptoms are worsening breathlessness, cough, increased sputum production and change in sputum colour. The change in these symptoms often necessitates a change in medication. NICE guidelines 201025. In this trial, patients will only be excluded if a change in medications were required - i.e. steroids or antibiotics.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Christie NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Christie NHS Foundation Trust

Manchester, Greater Manchester, United Kingdom

University Hospital South Manchester

Manchester, Greater Manchester, United Kingdom

Heartlands Hospital, Heart of England NHS Foundation Trust

Birmingham, , United Kingdom

Castle Hill Hospital, Hull and East Yorkshire Hospitals NHS Foundation Trust

Cottingham, , United Kingdom

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, , United Kingdom

The Clatterbridge Cancer Centre NHS Foundation Tust

Metropolitan Borough of Wirral, , United Kingdom

Scarborough General Hospital, York Teaching Hospital NHS Foundation Trust

Scarborough, , United Kingdom

Countries

United Kingdom

References

Yorke J, Johnson MJ, Punnett G, Smith J, Blackhall F, Lloyd Williams M, Mackereth P, Haines J, Ryder D, Krishan A, Davies L, Khan A, Molassiotis A. Respiratory distress symptom intervention for non-pharmacological management of the lung cancer breathlessness-cough-fatigue symptom cluster: randomised controlled trial. BMJ Support Palliat Care. 2024 Jan 8;13(e3):e1181-e1190. doi: 10.1136/spcare-2022-003924.

Reference Type: DERIVED

PMID: 36283797 (View on PubMed)

Other Identifiers

16_CPCR_01

Identifier Type: -

Identifier Source: org_study_id