Lung CancerRDSI-LCNCT03223805
Respiratory Distress Symptom Intervention (RDSI) Trial
A study testing Respiratory Distress Symptom Intervention in people with Lung Cancer, run by The Christie NHS Foundation Trust at 7 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Respiratory Distress Symptom Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- 4 Apr 2017to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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?
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
Heartlands Hospital, Heart of England NHS Foundation Trust
Birmingham
Castle Hill Hospital, Hull and East Yorkshire Hospitals NHS Foundation Trust
Cottingham
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool
The Christie NHS Foundation Trust
Manchester, Greater Manchester, M20 4QL
University Hospital South Manchester
Manchester, Greater Manchester, M23 9LT
The Clatterbridge Cancer Centre NHS Foundation Tust
Metropolitan Borough of Wirral
Scarborough General Hospital, York Teaching Hospital NHS Foundation Trust
Scarborough
About this study
Official title: A Randomised Controlled Trial to Determine the Clinical and Cost Effectiveness of the Respiratory Distress Symptom Intervention for People With Lung Cancer
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Respiratory Distress Symptom Intervention
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory Distress Symptom InterventionOther
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
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Other | Usual Care Receives: Other: Respiratory Distress Symptom Intervention |
| Intervention Arm | Experimental | Respiratory Distress Symptom Intervention plus Usual Care Receives: Other: Respiratory Distress Symptom Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 12 weeks
Secondary outcomes (4)
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).
Measured: 12 weeks
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
Measured: 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.
Measured: 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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start4 Apr 2017
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223805
- Sponsor's protocol ID
- 16_CPCR_01
- Acronym
- RDSI-LC
- Status last verified
- Nov 2021
- First submitted
- 12 Jul 2017
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36283797
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Determine the Clinical and Cost Effectiveness of the Respiratory Distress Symptom Intervention for People With Lung Cancer
- ClinicalTrials.gov ID
- NCT03223805
- Acronym / sponsor ID
- RDSI-LC / 16_CPCR_01
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Other | Other: Respiratory Distress Symptom InterventionUsual Care |
| Intervention Arm | Experimental | Other: Respiratory Distress Symptom InterventionRespiratory Distress Symptom Intervention plus Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory Distress Symptom InterventionThe 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 | Other | Control Arm, Intervention Arm |
Primary outcome
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).
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).
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.
4 secondary outcomes
NRS Ability to cope with symptoms.
Time frame: 12 weeks
Mood state - Hospital Anxiety & Depression Scale (HADS)
Time frame: 12 weeks
EQ-5D-5L
Time frame: 12 weeks
Health care utilisation
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Derived from this study: PubMed 36283797Yorke 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory Distress Symptom Intervention in people with Lung Cancer, run by The Christie NHS Foundation Trust at 7 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breathlessness (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03223805, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2021.