Does a breathlessness intervention service ('CBIS') reduce stress significantly more than usual care in breathless patients with advanced non-malignant disease and their carers? A phase II feasibility study

Not Applicable

Completed

• Conditions: Topic: Cardiovascular, Respiratory; Subtopic: Cardiovascular (all Subtopics), Respiratory (all Subtopics); Disease: Cardiovascular, Respiratory; Respiratory; Other and unspecified abnormalities of breathing

• Registration Number: ISRCTN70836126
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-26
• Study Completion: 2015-01-31
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Patients:
Any patient referred to CBIS with non-malignant disease who:
1. Has a diagnosed and investigated cause for breathlessness
2. Is troubled by breathlessness despite optimal medical therapy
3. May benefit from a self-management programme
4. Has an ?informal live-in? carer

Carers:
1. Is an informal carer (i.e not employed or paid as a carer) of the referred patient
2. Lives with the referred patient
3. Has some involvement in the patient?s day-to-day activities or care
4. Male & Female; lower age limit 18 years, upper age limit 100 years

Exclusion Criteria

Patients:
1. Active cancer
2. Rapidly progressing disease-course (CBIS cannot be delayed in this situation)
3. On corticosteroids at the time of screening or within the preceding month
4. Unable to provide informed consent
5. Has a baseline perceived stress scale (PSS) score of <12 (PSS is a scale for measuring subjective stress. The maximum score is 40 and a score of 12/40 is the average score for a normal population)
6. Does not fulfil the inclusion criteria

Carers:
1. On corticosteroids at the time of screening or within the preceding month
2. Suffers from breathlessness
3. Has a baseline PSS<12
4. Unable to provide informed consent
5. Works regular night shifts
6. Does not fulfil the inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diurnal Salivary Coritsol Profile; Timepoints: For parallel study: week 0 and 8, For longitudinal study (intervention arm only): week 0, 8,12, 20

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration