Change in disability in activities of daily living over time among adults with advanced respiratory disease during the COVID-19 pandemic
| ISRCTN | ISRCTN14159936 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14159936 |
| IRAS number | 271894 |
| Secondary identifying numbers | IRAS 271894 |
- Submission date
- 30/11/2020
- Registration date
- 14/12/2020
- Last edited
- 21/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
The researchers are very interested in finding out more about how people with advanced lung cancer or respiratory disease manage daily activities (e.g. washing, dressing, shopping, and walking) and how this changes over several months during the Coronavirus (COVID-19) pandemic. This is so they can identify when people with these conditions may become unable to manage everyday activities, what may cause them to have more difficulty (e.g. breathlessness) and what might help to improve their independence, in order to guide clinical practice and service provision.
This is important because people are living longer with advanced lung cancer or respiratory disease due to an ageing population and advances in treatment prolonging survival. This may change the illness trajectory of these conditions in terms of prolonging symptoms and disability. Disability in advanced disease has a specific effect on a persons’ ability to perform daily activities, limiting a patients’ independence and quality of life, impacting on care needs.
Who can participate?
Adults with a diagnosis of either advanced non-small cell lung cancer or respiratory disease (chronic obstructive lung disease (COPD) or interstitial lung disease (ILD))
What does the study involve?
This is an observational study of patients with advanced lung cancer or respiratory disease looking at how disability changes over time in daily activities (e.g. washing, dressing, shopping, walking) and associated factors including symptoms and social isolation. The researchers are recruiting from hospital and hospice in/outpatient settings throughout the UK and will be following participants for 6 months. Following consent, participants will complete a baseline questionnaire upon enrolment over the telephone and a series of monthly postal questionnaires over 6 months.
What are the possible benefits and risks of participating?
This research does not involve any changes to patient care, and so patients are unlikely to benefit personally from taking part, though participation may help to improve the care of others in future. The risks to taking part are very small, this research will not in any way affect the standard of clinical care participants might receive, care options, or any relationships they have with any staff or researchers. Some people may find some of the questions upsetting, but participants can choose not to answer questions if they do not want to and can withdraw at any time.
Where is the study run from?
Cicely Saunders Institute King’s College London (UK)
When is the study starting and how long is it expected to run for?
January 2020 to August 2021
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Lucy Fettes
lucy.fettes@kcl.ac.uk
Contact information
Scientific
Cicely Saunders Institute of Palliative Care, Policy & Rehabilitation
King’s College London
Bessemer Road
Denmark Hill
London
SE5 9PJ
United Kingdom
 ORCID ID |
0000-0002-2642-8318 |
|---|---|
| Phone | +44 (0)7854607441 |
| lucy.fettes@kcl.ac.uk |
Public
Cicely Saunders Institute of Palliative Care, Policy & Rehabilitation
King’s College London
Bessemer Road
Denmark Hill
London
SE5 9PJ
United Kingdom
| ORCID ID |
0000-0002-2642-8318 |
|---|---|
| Phone | +44 (0)7854607441 |
| lucy.fettes@kcl.ac.uk |
Study information
| Study design | Multi-center longitudinal prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Community |
| Study type | Other |
| Participant information sheet | ISRCTN14159936_PIS_V3.0_06May20.pdf |
| Scientific title | Comparing disability in activities of daily living over time among adults with advanced lung cancer or respiratory disease during the COVID-19 pandemic |
| Study acronym | DIScOVER |
| Study objectives | 1. People with advanced lung cancer develop greater disability in activities of daily living over time than people with advanced respiratory disease 2. Symptom severity is positively associated with subsequent disability in activities of daily living 3. Use of an assistive device is positively associated with increased independence in activities of daily living 4. Social isolation is positively associated with increased dependence in activities of daily living |
| Ethics approval(s) | Approved 11/02/2020, London - Camberwell St Giles Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK: +44 (0)207104 8204; nrescommittee.london-camberwellstgiles@nhs.net), REC ref: 19/LO/1950 |
| Health condition(s) or problem(s) studied | Exploring disability in patients with non-small cell lung cancer or respiratory disease |
| Intervention | Sample: advanced no small cell cancer or respiratory disease Recruitment sites: hospital lung cancer and respiratory inpatients and outpatient clinics; hospice/palliative care inpatients, outpatients, or community teams. Outcome variable: disability in activities of daily living Explanatory variables: symptom burden; assistive device use; social isolation Outcome measures: Barthel Index; Lawton Brody IADL scale; WHO Disability Assessment Scale (WHODAS 2.0); Palliative Outcomes Scale-Symptoms; Chronic Disease Self-Efficacy Social Support Sub-scale Data collection: Baseline self-reported questionnaire via telephone and monthly postal survey for 6 months or until death. |
| Intervention type | Other |
| Primary outcome measure | Disability (independence) in basic activities of daily living measured using the Barthel Index at baseline and monthly for 6 months |
| Secondary outcome measures | 1. Disability (independence) in instrumental activities of daily living measured using the Lawton Brody IADL scale at baseline and monthly for 6 months 2. Disability severity in activities of daily living measured using the WHO Disability Assessment Scale (WHODAS 2.0) at baseline and monthly for 6 months 3. Symptom burden measured using the Palliative Outcomes Scale-Symptoms (POS-S) at baseline and monthly for 6 months 4. Confidence to receive social support measured using the Chronic Disease Self-Efficacy Social Support Sub-scale at baseline |
| Overall study start date | 01/01/2020 |
| Completion date | 01/08/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 (60 non-small cell lung cancer, 60 respiratory disease) |
| Total final enrolment | 201 |
| Key inclusion criteria | 1. Patients aged >18 years 2. Advanced lung cancer or respiratory disease as defined by one of the following: 2.1. Lung cancer: Inoperable stage III or IV non-small cell lung cancer 2.2. Chronic Obstructive Lung Disease (COPD): Severe or very severe stages of COPD according to the criteria set by the Global Initiative for Chronic Obstructive Lung Disease (GOLD): stage III (FEV1/FVC <70%. 30% ≤ FEV1 <50% predicted with or without chronic symptoms (cough, sputum production)) and stage IV (FEV1/FVC <70%. FEV1 <30% predicted plus chronic respiratory failure) 2.3. Interstitial lung disease (ILD): Carbon monoxide transfer factor (TLCO/DLCO) level of <40% or FVC <50% predicted 3. Patients with capacity to consent 4. Patients with ability to understand and complete a questionnaire in English 5. Life expectancy of >1 month as assessed by the person taking consent |
| Key exclusion criteria | 1. Patients aged <18 years 2. Patients who lack the capacity to consent 3. Patients who lack the ability to understand and complete a questionnaire in English 4. Life expectancy of <1 month as assessed by the person taking consent |
| Date of first enrolment | 01/03/2020 |
| Date of final enrolment | 28/02/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Orpington
BR6 8ND
United Kingdom
Nottingham
NG5 1PB
United Kingdom
Macclesfield
SK10 3BL
United Kingdom
South Shields
NE34 0PL
United Kingdom
Truro
TR1 3LJ
United Kingdom
Kent
ME7 5NY
United Kingdom
London
SE26 6DZ
United Kingdom
Saint Leonards-on-sea
TN38 0LB
United Kingdom
Worthing
BN12 6NZ
United Kingdom
Worthing
BN11 2DH
United Kingdom
York
YO13 8HE
United Kingdom
London
SE1 9RT
United Kingdom
London
E1 8AA
United Kingdom
Sponsor information
Hospital/treatment centre
Research and Innovation Office
161 Denmark Hill
London
SE5 8EF
England
United Kingdom
| Phone | +44 (0)20 3299 1980 |
|---|---|
| kch-tr.research@nhs.net | |
| Website | https://www.kch.nhs.uk/ |
"ROR" |
https://ror.org/01n0k5m85 |
University/education
Research & Innovation
Floor 9, West Wing
Becket House
1 Lambeth Palace Rd
South Bank
London
SE1 7EU
England
United Kingdom
| Phone | +44 (0)207 1884557 |
|---|---|
| reza.razavi@kcl.ac.uk | |
| Website | http://www.kcl.ac.uk/index.aspx |
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
Results and Publications
| Intention to publish date | 01/02/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | Data will be archived in a secure unit at the Cicely Saunders Institute King’s College London for 7 years, which is specified in the participant information sheet. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V3.0 | 06/05/2020 | 04/01/2021 | No | Yes |
| Protocol file | version V2 | 06/05/2020 | 04/01/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 12/08/2021 | 04/01/2024 | Yes | No | |
| Results article | 10/12/2023 | 21/01/2025 | Yes | No |
Additional files
- ISRCTN14159936_PROTOCOL_V2_06May20.docx
- Uploaded 04/01/2021
- ISRCTN14159936_PIS_V3.0_06May20.pdf
- Uploaded 04/01/2021
Editorial Notes
21/01/2025: Publication reference and total final enrolment added.
04/01/2024: Publication reference added.
19/08/2022: The intention to publish date was changed from 01/08/2022 to 01/02/2023.
04/01/2021: The participant information sheet has been uploaded. Uploaded protocol Version 2, 06 May 2020 (not peer reviewed).
02/12/2020: Trial's existence confirmed by HRA and Health and Care Research Wales (HCRW).
