Back to resultsSELF-BREATHE RCT for Chronic Breathlessness
Primary Purpose
Cancer, COPD, Asthma
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
SELF-BREATHE
Sponsored by
About this trial
This is an interventional treatment trial for Cancer
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Breathlessness of unknown cause
- A primary diagnosis of chronic hyperventilation syndrome
- Currently participating in a rehabilitation programme, e.g. pulmonary/cardiac rehabilitation
Sites / Locations
- King's College Hospital NHS Foundation TRUSTRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
SELF-BREATHE
Control
Arm Description
Access to a self -guided, internet -based intervention for patients with chronic breathlessness known as SELF-BREATHE
standard / currently available NHS care
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04574050
First Posted
September 28, 2020
Last Updated
September 1, 2021
Sponsor
King's College Hospital NHS Trust
Collaborators
King's College London
1. Study Identification
Unique Protocol Identification Number
NCT04574050
Brief Title
SELF-BREATHE RCT for Chronic Breathlessness
Official Title
A Self - Guided, Internet - Based Intervention for Patients With Chronic Breathlessness (SELF-BREATHE): Feasibility Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 11, 2020 (Actual)
Primary Completion Date
April 4, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College Hospital NHS Trust
Collaborators
King's College London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A feasibility RCT comprising two groups:
Intervention (SELF-BREATHE in addition to standard NHS care)
Control group (standard / currently available NHS care)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, COPD, Asthma, Bronchiectasis Adult, Interstitial Lung Disease, Cystic Fibrosis, Chronic Heart Failure, Sickle Cell Disease, Renal Failure, Liver Failure, Post COVID-19, Dyspnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A feasibility RCT comprising two groups:
Intervention (SELF-BREATHE in addition to standard NHS care)
Control group (standard / currently available NHS care)
Masking
Outcomes Assessor
Masking Description
Single blind
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SELF-BREATHE
Arm Type
Experimental
Arm Description
Access to a self -guided, internet -based intervention for patients with chronic breathlessness known as SELF-BREATHE
Arm Title
Control
Arm Type
No Intervention
Arm Description
standard / currently available NHS care
Intervention Type
Other
Intervention Name(s)
SELF-BREATHE
Intervention Description
A self -guided, internet -based intervention for patients with chronic breathlessness
Primary Outcome Measure Information:
Title
Feasibility: the number of patients recruited into this study over a 12-month period
Description
The number of patients recruited into this study over a 12-month period
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Breathlessness of unknown cause
A primary diagnosis of chronic hyperventilation syndrome
Currently participating in a rehabilitation programme, e.g. pulmonary/cardiac rehabilitation
Facility Information:
Facility Name
King's College Hospital NHS Foundation TRUST
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Reilly, PhD
Phone
02032998062
Email
charles.reilly@nhs.net
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SELF-BREATHE RCT for Chronic Breathlessness
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