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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03223805
Recruitment Status : Completed
First Posted : July 21, 2017
Last Update Posted : December 10, 2021
Sponsor:
Information provided by (Responsible Party):
The Christie NHS Foundation Trust

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lung Cancer Other: Respiratory Distress Symptom Intervention Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 263 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomised Controlled Trial to Determine the Clinical and Cost Effectiveness of the Respiratory Distress Symptom Intervention for People With Lung Cancer
Actual Study Start Date : April 4, 2017
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Control Arm
Usual Care
 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
Experimental: Intervention Arm
Respiratory Distress Symptom Intervention plus Usual Care
 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


Outcome Measures
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Primary Outcome Measures :
  1. Breathlessness [ Time Frame: 12 weeks ]

    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).


  2. Cough [ Time Frame: 12 weeks ]
    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).

  3. Fatigue [ Time Frame: 12 weeks ]
    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 :
  1. NRS Ability to cope with symptoms. [ Time Frame: 12 weeks ]
    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).

  2. Mood state - Hospital Anxiety & Depression Scale (HADS) [ Time Frame: 12 weeks ]
    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

  3. EQ-5D-5L [ Time Frame: 12 weeks ]
    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.

  4. Health care utilisation [ Time Frame: 12 weeks ]
    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).


Other Outcome Measures:
  1. Carer outcome measures. Quality of Life (Caregiver Quality of Life Index-Cancer). [ Time Frame: 12 weeks ]
    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.

  2. Carer outcome measures. Mood state (Hospital Anxiety & Depression Scale). [ Time Frame: 12 weeks ]
    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.

  3. Carer outcome measures. Fatigue (FACIT-F) [ Time Frame: 12 weeks ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03223805


Locations
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United Kingdom
The Christie NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom, M20 4QL
University Hospital South Manchester
Manchester, Greater Manchester, United Kingdom, M23 9LT
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
Scarborough General Hospital, York Teaching Hospital NHS Foundation Trust
Scarborough, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Tust
Wirral, United Kingdom
Sponsors and Collaborators
The Christie NHS Foundation Trust
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: The Christie NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03223805    
Other Study ID Numbers: 16_CPCR_01
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: December 10, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases