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
• 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
• 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

Related Conditions & MeSH terms

• Cancer
• COPD
• Dyspnea
• Heart Failure
• Interstitial Disease

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