Clinical trial NCT03223805: Respiratory Distress Symptom Intervention (RDSI) Trial
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
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Breathlessness
timeFrame: 12 weeks
measure: Cough
timeFrame: 12 weeks
measure: Fatigue
timeFrame: 12 weeks
Secondary outcomes:
measure: NRS Ability to cope with symptoms.
timeFrame: 12 weeks
measure: Mood state - Hospital Anxiety & Depression Scale (HADS)
timeFrame: 12 weeks
measure: EQ-5D-5L
timeFrame: 12 weeks
measure: Health care utilisation
timeFrame: 12 weeks
Other outcomes:
measure: Carer outcome measures. Quality of Life (Caregiver Quality of Life Index-Cancer).
timeFrame: 12 weeks
measure: Carer outcome measures. Mood state (Hospital Anxiety & Depression Scale).
timeFrame: 12 weeks
measure: Carer outcome measures. Fatigue (FACIT-F)
timeFrame: 12 weeks
Locations:
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: University Hospital South Manchester
state: Greater Manchester
city: Birmingham
country: United Kingdom
facility: Heartlands Hospital, Heart of England NHS Foundation Trust
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital, Hull and East Yorkshire Hospitals NHS Foundation Trust
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital NHS Foundation Trust
city: Scarborough
country: United Kingdom
facility: Scarborough General Hospital, York Teaching Hospital NHS Foundation Trust
city: Wirral
country: United Kingdom
facility: The Clatterbridge Cancer Centre NHS Foundation Tust
Study officials:
References:
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. 2024 Jan 8;13(e3):e1181-e1190. doi: 10.1136/spcare-2022-003924.