Improving our understanding of factors influencing patient outcomes in pleural disease
| ISRCTN | ISRCTN17535598 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17535598 |
| IRAS number | 319757 |
| Secondary identifying numbers | CPMS 54190, IRAS 319757 |
- Submission date
- 10/01/2023
- Registration date
- 20/03/2023
- Last edited
- 06/11/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Respiratory
Plain English Summary
Background and study aims
The pleural membranes are two thin layers of tissue covering the outside of the lungs, which are vulnerable to different diseases including, pleural effusions, where excess fluid accumulates in the space between the lung and the chest wall (the pleural space); pneumothorax, where the pleural space fills with air causing the lung to collapse; pleural cancer (mesothelioma), this is usually associated with asbestos exposure; and, pleural thickening, where the lining around the lung becomes scarred, often because it has been inflamed in the past. All of these conditions can cause breathlessness, which can be severe. Unfortunately, a general lack of research means there are many unanswered questions regarding how best to diagnose and manage pleural diseases. There is often no single test that can provide us with a diagnosis, and patients frequently need multiple procedures to diagnose their condition and manage symptoms. We plan to create a new, long-term study to collect data on patients with pleural disease, to improve our understanding of how to diagnose and manage their condition, and the impact their disease and its management have on their quality of life.
Who can participate?
Any patient presenting to North Bristol’s tertiary pleural service with confirmed effusion, pneumothorax or pleural thickening, who is over the age of 16 and lives within reach of the service
What does the study involve?
The team will invite every patient who attends Southmead hospital with a pleural condition to take part in a simple follow-up study. Data will be recorded about participants’ health, and store small amounts of routinely collected blood, fluid and tissue for future laboratory tests. These samples will be used to apply more cutting-edge tests as they become available, which may improve the ability to diagnose the underlying cause of pleural disease. This study does not require any additional visits to the hospital in addition to routine care. Patients will also be asked to fill out brief questionnaires at enrolment, 4 months and 12 months after enrolling about how they are affected by their condition.
What are the possible benefits and risks of participating?
There are no direct clinical benefits to participants from engaging in this research as it is observational. Once the results are published, it is hoped that the knowledge obtained will benefit patients in the future by helping clinicians understand better how to manage patients with this condition, taking into account different factors that may influence their outcomes. The observational nature of the study means that there are no additional risks to patients from participating.
Where is the study run from?
The lead site is North Bristol NHS Trust, Southmead Hospital (UK)
When is the study starting and how long is it expected to run for?
June 2021 to March 2029
Who is funding the study?
1. Rocket Medical Plc (UK)
2. Southmead Hospital Charity (UK)
3. National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
Dr Eleanor Barton, eleanor.barton@nbt.nhs.uk (UK)
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-new-ways-to-diagnose-and-monitor-people-with-diseases-of-the-lung-lining
Contact information
Scientific
Pleural Clinical Research Fellow
Academic Respiratory Unit
North Bristol NHS Trust
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
 ORCID ID |
0000-0003-0381-810X |
|---|---|
| Phone | +44 (0)117 414 8033 |
| eleanor.barton@nbt.nhs.uk |
Study information
| Study design | Single-centre longitudinal prospective observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Severn Pleural Disease Outcomes: Long Term Insights Study |
| Study acronym | SPOTLight |
| Study hypothesis | The aim of this long-term observational study is to improve our understanding of the long-term, patient-reported outcomes of pleural disease. |
| Ethics approval(s) | Approved 24/02/2023, Wales REC 6 (Public Health Wales, Building 1, Jobswell Road, St David’s Park, SA31 3HB, UK; +44 1267 61 1164; Wales.REC6@wales.nhs.uu), ref: 23/WA/0018 |
| Condition | Respiratory |
| Intervention | Patients presenting with radiologically confirmed pleural disease including (but not limited to) pneumothorax, pleural effusion, pleural thickening or pleural cancer (mesothelioma) to North Bristol NHS Trust will be screened and invited to participate by a member of the study team. The team will collect data on the patient’s demographics, past medical history and history of current illness, smoking status including cannabis, asbestos and other inhalational exposures, clinical frailty score (CFS) and performance status (PS). The team will also collect data related to their condition and its management, for example, radiological and thoracic ultrasound appearances, the number and type of interventions undertaken and digital measurements of air leaks in the case of pneumothorax. For patients with pleural effusions, if blood or pleural fluid samples are collected as part of their routine care, additional research samples will also be collected for use in current or future studies. For patients who undergo a pleural biopsy procedure following enrolment, additional tissue samples may be obtained and retained for research purposes if felt appropriate by the operator. These data and sample collections are not study-specific procedures but are performed as part of the participants’ routine clinical care. At enrolment and 4- and 12-months post-enrolment, patients will be asked to complete 2 routine questionnaires to provide patient-reported outcome measures. These are study-specific, not part of the patient’s routine care. Where necessary, additional PROMS relevant to a specific sub-study the patient may be eligible for may also be collected during the baseline assessment. These will be undertaken at the initial assessment, and either remotely, or during the routine clinical review at 4 and 12 months. Further data will be collected from the patient’s medical records at 4 months and 12 months post enrolment, to encompass the patient’s length of stay, number and type of interventions, and mortality. These two timepoints allow for the collection of complete data sets, acknowledging that some patients may have a prolonged diagnostic pathway or require recurrent procedures to manage their symptoms. A final diagnosis will be recorded after 12 months, based on the diagnosis of their treating clinician, and ratified by a second pleural specialist. |
| Intervention type | Other |
| Primary outcome measure | 1. Breathlessness and pain measured using the patient-reported outcome measures (PROMs) Visual Analogue Scale (VAS) at baseline, 4 months and 12 months 2. Health-related quality of life measured using the EuroQol 5D Health Questionnaire (EQ-5D-5L) at baseline, 4 months and 12 months |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 30/06/2021 |
| Overall study end date | 01/03/2029 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 1000; UK Sample Size: 1000 |
| Participant inclusion criteria | 1. Confirmed presence (radiologically) of either: 1.1. Pleural effusion/pleural thickening OR 1.2. Spontaneous primary or secondary pneumothorax 2. Patient normally lives within the catchment area of the Bristol hospitals and is unlikely to relocate within 12 months 3. Aged 16 years old and over 4. Has access to telephone and/or internet |
| Participant exclusion criteria | To be eligible to participate in the cohort, none of the following criteria should apply: 1. Previously enrolled in SPOTLight 2. Patient (or appropriate proxy) is not able to provide written informed consent 3. Patient is in the final stages of life or sufficiently frail to make study involvement inappropriate |
| Recruitment start date | 02/05/2023 |
| Recruitment end date | 02/05/2028 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
Sponsor information
Hospital/treatment centre
Research and Innovation
Floor 3, Learning and Research Centre
Bristol
BS10 5NB
England
United Kingdom
| Phone | +44 (0)1174149330 |
|---|---|
| Researchsponsor@nbt.nhs.uk | |
| Website | http://www.nbt.nhs.uk/ |
"ROR" |
https://ror.org/036x6gt55 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
No information available
Government organisation / Local government
- Alternative name(s)
- NBT
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/03/2030 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | 1. Planned publication in a high-impact and peer-reviewed journal 2. A specific dissemination plan will be devised for each individual question as it is studied and a full report prepared upon completion of the study 3. Presentation of study results at conferences 4. Study results will be accessible via the Academic Respiratory Unit webpage |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.0 | 16/11/2022 | 16/01/2023 | No | No |
| HRA research summary | 26/07/2023 | No | No |
Additional files
Editorial Notes
06/11/2024: Cancer Research UK plain English summary link added to plain English summary field.
05/04/2023: The following changes were made to the trial record:
1. The ethics approval was added.
2. The recruitment start date was changed from 01/03/2023 to 02/05/2023.
3. The recruitment end date was changed from 01/03/2028 to 02/05/2028.
10/01/2023: Trial's existence confirmed by the NIHR.
