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NCT04466020 Clinical Trial

SELF - BREATHE for Chronic Breathlessness

Cancer Clinical Trial

Official title:
A Self -Guided, Internet -Based Intervention for Patients With Chronic Breathlessness (SELF-BREATHE): an Interview Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04466020
Other study ID # KCH20-056
Secondary ID ICA-CL-2018-04-S
Status Completed
Phase
First received
Last updated
Start date June 3, 2020
Est. completion date November 11, 2020

Study information
Verified date September 2021
Source King's College Hospital NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Semi-structured qualitative interviews will be conducted to understand key factors that would enable / facilitate patients with chronic breathlessness to potentially use an online breathlessness intervention (SELF-BREATHE).

Description:

STUDY OVERVIEW Full title: A self -guided, internet -based intervention for patients with chronic breathlessness (SELF-BREATHE): an interview study. Objective: To understand the key factors that would enable / facilitate patients with chronic breathlessness to use an online breathlessness support intervention (SELF-BREATHE). Study type: Qualitative interview study Methods: Semi-structured qualitative interviews will be conducted to achieve maximum variation in approx 20 patients with chronic breathlessness (a purposive sample: age sex, diagnoses, and presence of caregiver). The interview will explore and identify: Patients' views/experiences of internet-based activities, e.g. digital apps, shopping online; Patients' understanding, preferences, values and motivations that would influence uptake of SELF-BREATHE; Potential barriers to the development and use of SELF-BREATHE; Facilitators to usage of SELF-BREATHE, such as the ability to self-monitor progress etc... These topics cover areas of uncertainty in order to optimise the SELF - BREATHE intervention. Inclusion criteria: Adult patients >18 years of age, with the ability to read, converse in English and able to provide informed consent Chronic breathlessness on exertion and or rest (MRC dysponea score >2) Advanced disease such as cancer, chronic obstructive pulmonary disease (COPD), chronic heart failure (CHF) or interstitial lung disease (ILD), where the underlying disease is deemed to be optimally medically managed by the referring clinician / allied health professional / clinical nurse specialist Exclusion criteria: Breathlessness of unknown cause A primary diagnosis of chronic hyperventilation syndrome

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date November 11, 2020
Est. primary completion date November 11, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Adult patients >18 years of age, with the ability to read, converse in English and able to provide informed consent - Chronic breathlessness on exertion and or rest (MRC dyspnea score >2) - Advanced disease such as cancer, chronic obstructive pulmonary disease (COPD), chronic heart failure (CHF) or interstitial lung disease (ILD), where the underlying disease is deemed to be optimally medically managed by the referring clinician / allied health professional / clinical nurse specialist Exclusion Criteria: - Breathlessness of unknown cause - A primary diagnosis of chronic hyperventilation syndrome

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Qualitative research interviews to be conducted
None. Qualitative research interviews to be conducted

Locations
Country Name City State
United Kingdom King's College Hospital NHS Foundation Trust London

Sponsors (2)
Lead Sponsor Collaborator
King's College Hospital NHS Trust King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Descriptive qualitative analysis of patients' preferences, values and motivations that would influence the use of an online self - management intervention for chronic breathlessness (SELF-BREATHE). Qualitative data 12 months
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