Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Richella Ryan

ORCID ID

Contact details

Palliative Care Team
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
richella.ryan@addenbrookes.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14073

Study information

Scientific title

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

First MREC approval date 21/02/2013, ref: 13/EE/0021

Study design

Randomised interventional trial; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

11/03/2013

Overall trial end date

31/01/2015

Reason abandoned

Eligibility

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 patient’s day-to-day activities or care
4. Male & Female; lower age limit 18 years, upper age limit 100 years

Participant type

Patient

Age group

Adult

Gender

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 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

United Kingdom

Trial participating centre

Palliative Care Team
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.cuh.org.uk

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Editorial Notes