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

ISRCTN	ISRCTN70836126
DOI	https://doi.org/10.1186/ISRCTN70836126
Secondary identifying numbers	14073

Submission date: 25/04/2013
Registration date: 26/04/2013
Last edited: 29/05/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Dr Richella Ryan
Scientific

Palliative Care Team
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Email	rcr41@medschl.cam.ac.uk

Study information

Study design	Randomised interventional trial; Design type: Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	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
Study acronym	BISCORT
Study hypothesis	Background: Breathlessness is common in people with serious heart and lung disease. Experts agree that using a number of treatments together (e.g. exercise, relaxation, medication) brings the greatest improvement. The Cambridge Breathlessness-Intervention Service (CBIS) uses this approach in patients and their carers. We think that 'CBIS' works by reducing stress. Stress levels in the body can be assessed by measuring the amount of a hormone called cortisol in saliva. Aim: We want to know whether CBIS reduces stress. We can only answer this question accurately by doing a large study. This is a small study testing our methods before doing the large study. Methods: We plan to recruit 36 patients along with their carers. Half of the participants will receive 'CBIS' and half of them will not. We will measure salivary cortisol levels before and after study entry (at 0 and 8 weeks) in both the participants receiving the service and in those who do not receive the service. In addition, participants will be asked to complete questionnaires about their level of breathlessness and stress. We will also measure sleep and inflammation as these phenomena are related to chronic stress. At 8 weeks, we will compare the results between the two groups. Those who receive CBIS will have further measurements taken at 12 and 20 weeks to establish whether there is a long-term change in the measures. All participants will be invited to take part in an interview about their experience of the study at 20 weeks. More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=14073
Ethics approval(s)	First MREC approval date 21/02/2013, ref: 13/EE/0021
Condition	Topic: Cardiovascular, Respiratory; Subtopic: Cardiovascular (all Subtopics), Respiratory (all Subtopics); Disease: Cardiovascular, Respiratory
Intervention	CBIS, The Cambridge Breathlessness Intervention Service (CBIS) is a multidisciplinary service consisting of a medical consultant, an occupational therapist and a physiotherapist. It uses a psychologically-informed and rehabilitative approach to address the multi-dimensional nature of breathlessness. The intervention consists of multiple interacting components which are delivered in a flexible manner.
Intervention type	Other
Primary outcome measure	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	Not provided at time of registration
Overall study start date	11/03/2013
Overall study end date	31/01/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	UK Sample Size: 72; Description: The sample will consist of 36 patient-carer dyads, resulting in a total of 72 participants.
Participant 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 patients day-to-day activities or care 4. Male & Female; lower age limit 18 years, upper age limit 100 years
Participant 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
Recruitment start date	11/03/2013
Recruitment end date	31/01/2015

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Palliative Care Team

Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Palliative Care Team
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom

Website	http://www.cuh.org.uk
"ROR"	https://ror.org/04v54gj93

Funders

Funder type

Government

NIHR (UK) - Doctoral Research Fellowship; Grant Codes: NIHR-DRF-2012-05-702

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

29/05/2020: No publications found.
07/06/2019: Internal review.
03/06/2019: Contact details updated.
31/05/2019: Internal review.
06/01/2017: No publications found in PubMed, verifying study status with principal investigator.