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Respiratory Distress Symptom Intervention (RDSI) Trial (RDSI-LC)

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Respiratory Distress Symptom Intervention
Sponsored by
The Christie NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Christie NHS Foundation Trust
  • University Hospital South Manchester
  • Heartlands Hospital, Heart of England NHS Foundation Trust
  • Castle Hill Hospital, Hull and East Yorkshire Hospitals NHS Foundation Trust
  • Liverpool Heart and Chest Hospital NHS Foundation Trust
  • Scarborough General Hospital, York Teaching Hospital NHS Foundation Trust
  • The Clatterbridge Cancer Centre NHS Foundation Tust

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control Arm

Intervention Arm

Arm Description

Usual Care

Respiratory Distress Symptom Intervention plus Usual Care

Outcomes

Primary Outcome Measures

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).
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).
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.

Secondary Outcome Measures

NRS Ability to cope with symptoms.
Consists of 3 items, breathlessness, cough and fatigue, each on a NRS ranging from 0 (not able to cope at all) to 10 (completely able to cope).
Mood state - Hospital Anxiety & Depression Scale (HADS)
This is a 14-item scale assessing anxiety with 7 items and depression with a further 7 items. Each item is answered on a 4-point scale (0-3). Scores on each sub-scale thus range between 0 (no symptoms) and 21 (numerous and severe symptoms). Higher scores are indicative of more anxiety and depression, scores below 8 are considered to be in the normal range, 8-10 are borderline, and scores above 11 indicates a disorder of relevant mood
EQ-5D-5L
EQ-5D is a standardised instrument for use as a measure of health outcome. It is applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care as well as in population health surveys. The EuroQoL 5-level version (EQ-5D-5L) will be assessed to provide a preference based measure of health-related quality-of-life which will enable us to calculate a quality adjusted life-year for use in the cost-effectiveness analysis.
Health care utilisation
Assessment of resource use will be assessed via patient-recall using a standardised instrument at baseline (previous 4 weeks), week 4 and week 12. Utilisation of resource being measured include: planned hospital or hospice overnight stays, planned hospital out-patient visits, hospital emergency visits, hospital admissions (days/nights), GP and other community service visits (community nurse, walk-in centre, occupational therapist, care worker, home help, social worker).

Full Information

First Posted
July 12, 2017
Last Updated
November 29, 2021
Sponsor
The Christie NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03223805
Brief Title
Respiratory Distress Symptom Intervention (RDSI) Trial
Acronym
RDSI-LC
Official Title
A Randomised Controlled Trial to Determine the Clinical and Cost Effectiveness of the Respiratory Distress Symptom Intervention for People With Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 4, 2017 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Christie NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
263 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
Other
Arm Description
Usual Care
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Respiratory Distress Symptom Intervention plus Usual Care
Intervention Type
Other
Intervention Name(s)
Respiratory Distress Symptom Intervention
Intervention Description
The RDSI comprises of four components 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 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 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 Exercise: Individually-tailored exercise plan, for example, walking incrementally increasing distances in their local environment, incorporating breathing techniques as required
Primary Outcome Measure Information:
Title
Breathlessness
Description
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).
Time Frame
12 weeks
Title
Cough
Description
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).
Time Frame
12 weeks
Title
Fatigue
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
NRS Ability to cope with symptoms.
Description
Consists of 3 items, breathlessness, cough and fatigue, each on a NRS ranging from 0 (not able to cope at all) to 10 (completely able to cope).
Time Frame
12 weeks
Title
Mood state - Hospital Anxiety & Depression Scale (HADS)
Description
This is a 14-item scale assessing anxiety with 7 items and depression with a further 7 items. Each item is answered on a 4-point scale (0-3). Scores on each sub-scale thus range between 0 (no symptoms) and 21 (numerous and severe symptoms). Higher scores are indicative of more anxiety and depression, scores below 8 are considered to be in the normal range, 8-10 are borderline, and scores above 11 indicates a disorder of relevant mood
Time Frame
12 weeks
Title
EQ-5D-5L
Description
EQ-5D is a standardised instrument for use as a measure of health outcome. It is applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care as well as in population health surveys. The EuroQoL 5-level version (EQ-5D-5L) will be assessed to provide a preference based measure of health-related quality-of-life which will enable us to calculate a quality adjusted life-year for use in the cost-effectiveness analysis.
Time Frame
12 weeks
Title
Health care utilisation
Description
Assessment of resource use will be assessed via patient-recall using a standardised instrument at baseline (previous 4 weeks), week 4 and week 12. Utilisation of resource being measured include: planned hospital or hospice overnight stays, planned hospital out-patient visits, hospital emergency visits, hospital admissions (days/nights), GP and other community service visits (community nurse, walk-in centre, occupational therapist, care worker, home help, social worker).
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Carer outcome measures. Quality of Life (Caregiver Quality of Life Index-Cancer).
Description
This is a 35-item scale evaluating the quality of life of those caring for cancer patients and the impact of caregiving on carers' life.
Time Frame
12 weeks
Title
Carer outcome measures. Mood state (Hospital Anxiety & Depression Scale).
Description
This is a 14-item scale assessing anxiety with 7 items and depression with a further 7 items. Each item is answered on a 4-point scale (0-3). Scores on each sub-scale thus range between 0 (no symptoms) and 21 (numerous and severe symptoms). Higher scores are indicative of more anxiety and depression, scores below 8 are considered to be in the normal range, 8-10 are borderline, and scores above 11 indicates a disorder of relevant mood.
Time Frame
12 weeks
Title
Carer outcome measures. Fatigue (FACIT-F)
Description
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F )31 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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 18+ 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? Exclusion Criteria: 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.
Facility Information:
Facility Name
The Christie NHS Foundation Trust
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 4QL
Country
United Kingdom
Facility Name
University Hospital South Manchester
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
Heartlands Hospital, Heart of England NHS Foundation Trust
City
Birmingham
Country
United Kingdom
Facility Name
Castle Hill Hospital, Hull and East Yorkshire Hospitals NHS Foundation Trust
City
Cottingham
Country
United Kingdom
Facility Name
Liverpool Heart and Chest Hospital NHS Foundation Trust
City
Liverpool
Country
United Kingdom
Facility Name
Scarborough General Hospital, York Teaching Hospital NHS Foundation Trust
City
Scarborough
Country
United Kingdom
Facility Name
The Clatterbridge Cancer Centre NHS Foundation Tust
City
Wirral
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
36283797
Citation
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. 2022 Oct 25:spcare-2022-003924. doi: 10.1136/spcare-2022-003924. Online ahead of print.
Results Reference
derived

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Respiratory Distress Symptom Intervention (RDSI) Trial

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