Respiratory Distress Symptom Intervention (RDSI) Trial

NCT03223805 | Completed

• 1 other identifier: 16_CPCR_01
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 7

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (3)

• Breathlessness

  Dyspnoea-12 Dyspnoea-12(D-12)27. Dyspnoea-12: is the primary outcome for breathlessness. It provides an assessment of total breathlessness severity that incorporates its physical discomfort and emotional consequences. It has been validated in a range of respiratory conditions including lung cancer (unpublished data).

  12 weeks

• Cough

  The Manchester Cough in Lung Cancer scale. This is a patient self-report consisting of 10 items. This is the only lung cancer specific scale available for the assessment of cough30. Evidence of MCLC reliability and validity has been further reported in intrathoracic malignancy (unpublished PhD data).

  12 weeks

• Fatigue

  The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) This is a 13-item standalone scale with good psychometric properties and established minimally important difference. It is commonly used for the assessment of fatigue in lung cancer with good psychometric properties.

  12 weeks

Secondary Outcomes (4)

• NRS Ability to cope with symptoms.

  12 weeks

• Mood state - Hospital Anxiety & Depression Scale (HADS)

  12 weeks

• EQ-5D-5L

  12 weeks

• Health care utilisation

  12 weeks

Other Outcomes (3)

• Carer outcome measures. Quality of Life (Caregiver Quality of Life Index-Cancer).

  12 weeks

• Carer outcome measures. Mood state (Hospital Anxiety & Depression Scale).

  12 weeks

• Carer outcome measures. Fatigue (FACIT-F)

  12 weeks

Study Arms (2)

Control Arm

OTHER

Usual Care

Other: Respiratory Distress Symptom Intervention

Intervention Arm

EXPERIMENTAL

Respiratory Distress Symptom Intervention plus Usual Care

Other: Respiratory Distress Symptom Intervention

Interventions

Respiratory Distress Symptom Intervention 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

Control Arm; Intervention Arm

Eligibility Criteria

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

You may qualify if:

• A diagnosis of lung cancer - primary tumour, secondary tumour or mesothelioma
• 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)\*
• In the presence of COPD, in stable condition
• WHO Performance Status 0-2
• Expected prognosis of at least 3 months
• + years
• 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?

You may not qualify if:

• Patients who are experiencing breathlessness, cough and/or fatigue but do not find these symptoms bothersome are not eligible (see below)\*
• Acute exacerbation\*\* of COPD, or chest infection, within the past 3 weeks, necessitating a change in medication
• Rapidly worsening breathlessness requiring urgent medical intervention
• Post chemotherapy and/or radiotherapy to the chest \> 2 weeks
• 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.

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead

Study Sites (7)

The Christie NHS Foundation Trust

Manchester, Greater Manchester, M20 4QL, United Kingdom

Location

University Hospital South Manchester

Manchester, Greater Manchester, M23 9LT, United Kingdom

Location

Heartlands Hospital, Heart of England NHS Foundation Trust

Birmingham, United Kingdom

Location

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

Cottingham, United Kingdom

Location

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, United Kingdom

Location

The Clatterbridge Cancer Centre NHS Foundation Tust

Metropolitan Borough of Wirral, United Kingdom

Location

Scarborough General Hospital, York Teaching Hospital NHS Foundation Trust

Scarborough, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 36283797 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 21, 2017
• Study Start: April 4, 2017
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: December 10, 2021

Record last verified: 2021-11

Locations

GB (7)