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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 10.1186/ISRCTN70836126
ClinicalTrials.gov identifier
EudraCT number
Public 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
Scientific title
Acronym BISCORT
Serial number at source 14073
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
Lay summary Not provided at time of registration
Ethics approval First MREC approval date 21/02/2013, ref: 13/EE/0021
Study design Randomised interventional trial; Design type: Treatment
Countries of recruitment United Kingdom
Disease/condition/study domain Topic: Cardiovascular, Respiratory; Subtopic: Cardiovascular (all Subtopics), Respiratory (all Subtopics); Disease: Cardiovascular, Respiratory
Participants - 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
Participants - 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
Anticipated start date 11/03/2013
Anticipated end date 31/01/2015
Status of trial Ongoing
Patient information material
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.
Interventions 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.
Primary outcome measure(s) 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 measure(s) Not provided at time of registration
Sources of funding NIHR (UK) - Doctoral Research Fellowship; Grant Codes: NIHR-DRF-2012-05-702
Trial website
Publications
Contact name Dr  Richella  Ryan
  Address Palliative Care Team
Addenbrookes Hospital
Hills Road
  City/town Cambridge
  Zip/Postcode CB2 0QQ
  Country United Kingdom
  Email richella.ryan@addenbrookes.nhs.uk
Sponsor Cambridge University Hospitals NHS Foundation Trust (UK)
  Address Palliative Care Team
Addenbrookes Hospital
Hills Road
  City/town Cambridge
  Zip/Postcode CB2 0QQ
  Country United Kingdom
  Sponsor website: http://www.cuh.org.uk
Date applied 25/04/2013
Last edited 26/04/2013
Date ISRCTN assigned 26/04/2013
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