CancerNCT04574050
SELF-BREATHE RCT for Chronic Breathlessness
A study testing SELF-BREATHE in people with Cancer and COPD, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
A feasibility RCT comprising two groups: 1. Intervention (SELF-BREATHE in addition to standard NHS care) 2. Control group (standard / currently available NHS care) Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- SELF-BREATHE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Jan 2021to 30 Jan 2022
- 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
- Adults ≥ 18 years of age, with the ability to read and type in English
- Access to a computer, or tablet or smart phone, with internet access and the ability to email
- Chronic breathlessness (CB) defined as; breathlessness that persists (>3months) despite optimal pharmacological treatment of the underlying disease including cancer, chronic obstructive pulmonary disease (COPD),asthma, interstitial lung disease (ILD), bronchiectasis, cystic fibrosis (CF) chronic heart failure (CHF), sickle cell disease, chronic renal/ liver failure or post COVID-19
- Chronic breathlessness at rest or on exertion; MRC dysponea score >2
- Willing to engage with short-term self-guided internet-based breathlessness intervention (SELF-BREATHE)
- Able to provide informed consent
Who cannot join
- Breathlessness of unknown cause
- A primary diagnosis of chronic hyperventilation syndrome
- Currently participating in a rehabilitation programme, e.g. pulmonary/cardiac rehabilitation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
King's College Hospital NHS Foundation TRUST
London, SE5 9RS
About this study
Official title: A Self - Guided, Internet - Based Intervention for Patients With Chronic Breathlessness (SELF-BREATHE): Feasibility Randomised Controlled Trial
A feasibility RCT comprising two groups:
- Intervention (SELF-BREATHE in addition to standard NHS care)
- Control group (standard / currently available NHS care)
- Conditions
- Cancer, COPD, Asthma, Bronchiectasis Adult, Interstitial Lung Disease, Cystic Fibrosis
- Being tested
- SELF-BREATHE
- Medical subject headings
- Neoplasms, Pulmonary Disease, Chronic Obstructive, Asthma, Lung Diseases, Interstitial, Cystic Fibrosis, Anemia, Sickle Cell, Renal Insufficiency, Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SELF-BREATHEOther
A self -guided, internet -based intervention for patients with chronic breathlessness
| Study group | Role | What they receive |
|---|---|---|
| SELF-BREATHE | Experimental | Access to a self -guided, internet -based intervention for patients with chronic breathlessness known as SELF-BREATHE Receives: Other: SELF-BREATHE |
| Control | No intervention | standard / currently available NHS care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: the number of patients recruited into this study over a 12-month period
The number of patients recruited into this study over a 12-month period
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start11 Jan 2021
- Primary completion11 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A feasibility RCT comprising two groups: 1. Intervention (SELF-BREATHE in addition to standard NHS care) 2. Control group (standard / currently available NHS care)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574050
- Sponsor's protocol ID
- IRAS 285303
- Other IDs
- 20/LO/1108
- Status last verified
- Mar 2024
- First submitted
- 28 Sep 2020
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Self - Guided, Internet - Based Intervention for Patients With Chronic Breathlessness (SELF-BREATHE): Feasibility Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04574050
- Acronym / sponsor ID
- IRAS 285303
- Conditions
- Cancer, COPD, Asthma, Bronchiectasis Adult, Interstitial Lung Disease, Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 11 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 5 Oct 2020 (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.
A feasibility RCT comprising two groups:
- Intervention (SELF-BREATHE in addition to standard NHS care)
- Control group (standard / currently available NHS care)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A feasibility RCT comprising two groups: 1. Intervention (SELF-BREATHE in addition to standard NHS care) 2. Control group (standard / currently available NHS care)
| Arm | Type | Receives |
|---|---|---|
| SELF-BREATHE | Experimental | Other: SELF-BREATHEAccess to a self -guided, internet -based intervention for patients with chronic breathlessness known as SELF-BREATHE |
| Control | No intervention | –standard / currently available NHS care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults ≥ 18 years of age, with the ability to read and type in English
- Access to a computer, or tablet or smart phone, with internet access and the ability to email
- Chronic breathlessness (CB) defined as; breathlessness that persists (>3months) despite optimal pharmacological treatment of the underlying disease including cancer, chronic obstructive pulmonary disease (COPD),asthma, interstitial lung disease (ILD), bronchiectasis, cystic fibrosis (CF) chronic heart failure (CHF), sickle cell disease, chronic renal/ liver failure or post COVID-19
- Chronic breathlessness at rest or on exertion; MRC dysponea score >2
- Willing to engage with short-term self-guided internet-based breathlessness intervention (SELF-BREATHE)
Key exclusion criteria (3 listed)
- Breathlessness of unknown cause
- A primary diagnosis of chronic hyperventilation syndrome
- Currently participating in a rehabilitation programme, e.g. pulmonary/cardiac rehabilitation
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 |
|---|---|---|
| SELF-BREATHEA self -guided, internet -based intervention for patients with chronic breathlessness | Other | SELF-BREATHE |
Primary outcome
Feasibility: the number of patients recruited into this study over a 12-month period
Time frame: 12 months
The number of patients recruited into this study over a 12-month period
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 19 Mar 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SELF-BREATHE in people with Cancer and COPD, run by King's College Hospital NHS Trust at 1 site 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 6 inclusion and 3 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 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Feasibility: the number of patients recruited into this study over a 12-month period (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2024.