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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | Other | Usual Care |
|
| Intervention Arm | Experimental | Respiratory Distress Symptom Intervention plus Usual Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respiratory Distress Symptom Intervention | Other | The RDSI comprises of four components
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 It has been validated in a range of respiratory conditions including lung cancer (unpublished data).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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 weeks |
| Mood state - Hospital Anxiety & Depression Scale (HADS) |
| Measure | Description | Time Frame |
|---|---|---|
| Carer outcome measures. Quality of Life (Caregiver Quality of Life Index-Cancer). | 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. | 12 weeks |
| Carer outcome measures. Mood state (Hospital Anxiety & Depression Scale). |
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
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
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Christie NHS Foundation Trust | Manchester | Greater Manchester | M20 4QL | United Kingdom | ||
| University Hospital South Manchester |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36283797 | Derived | 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. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
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
| 12 weeks |
| 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. | 12 weeks |
| 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). | 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. |
| 12 weeks |
| Carer outcome measures. Fatigue (FACIT-F) | 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. | 12 weeks |
| Manchester |
| Greater Manchester |
| M23 9LT |
| 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 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |