Condition category
Respiratory
Date applied
30/10/2008
Date assigned
18/12/2008
Last edited
06/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mrs Jennifer Gray

ORCID ID

Contact details

Breathlessness Intervervention Service
Box 193 Palliative Care
Addenbrooke's Hospital
Cambridge University Hospital's NHS Foundation Trust
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Type

Scientific

Additional contact

Dr Sara Booth

ORCID ID

Contact details

Addenbrooke's Hospital
Cambridge University Hospitals NHS Foundation Trust
Palliative Care Box 193
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00678405

Protocol/serial number

v2 09/09/08

Study information

Scientific title

Phase III randomised controlled trial of a breathlessness intervention service for intractable breathlessness

Acronym

Phase III RCT BIS

Study hypothesis

The aim of this study is to evaluate the impact of the Breathlessness Intervention Service (BIS) on the quality of life of patients and families affected by intractable breathlessness. The questions to be addressed by the research are:
1. Is BIS more effective than standard care for patients with intractable breathlessness from advanced malignant or non-malignant disease?
2. Does it reduce patient and carer distress due to breathlessness, and increase patients' sense of mastery of the symptom?
3. What are the experiences and views of those who use BIS, their informal carers and the clinicians who refer to it?
4. Is BIS cost-effective?

Ethics approval

Cambridgeshire 2 Research Ethics Committee, July 2008. Substantial amendment submitted in September 2008 and approved October 2008.

Study design

Randomised controlled phase III (MRC's framework for complex interventions) parallel-assignment single-blind (investigator) trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information material can be found at: http://www.cancerhelp.org.uk/trials/trials/trial.asp?=&trialno=15866

Condition

Intractable breathlessness, malignant and non-malignant conditions

Intervention

Active comparator:
Waiting list groups (malignant and non-malignant) - best supportive care (standard care). Standard care entails specialist outpatient appointments in secondary care (e.g. respiratory, cardiology, neurology or oncology), which may include specialist nurse input, and primary care services.

Experimental:
Fast-track (malignant and non-malignant) Breathlessness Intervention Service. The Breathlessness Intervention Service consists of a clinical specialist physiotherapist and palliative care consultant. It aims to manage the symptom of breathlessness in patients with any disease using a rehabilitative approach. Interventions include: evidence based non-pharmacological interventions (psychological, social and physical); palliative care input (e.g. end of life issues, psychosocial issues, family concerns) and pharmacological review. BIS seeks to enhance the self-management of breathlessness. The treatment is holistic in nature in that it is located in clinic or in patient's home as appropriate. Referrals come from medical specialists, GPs and allied health professionals.

The two broad disease courses, malignant and non-malignant, will be considered separately due to their different trajectories and needs, and resultant different service models. The intervention model for patients with non-malignant disease consists of two - three visits and three telephone contacts (to patient and/or primary care staff) over a four-week period with a 16 week (from first assessment) follow-up, whereas the model for patients with malignant disease consists of one visit in conjunction with a primary care professional/key worker and two telephone contacts (to patient and/or primary care staff/key worker) over a two-week period, with a six week (from first assessment) follow-up. Thus, the measurement points for the disease groups will differ.

Timepoints for non-malignant group:
Fast-track group: after baseline interview (t1), the fast-track group will receive BIS for four weeks. The next measurement (nmFTt2) will be conducted midway through the intervention (2 weeks post-commencing BIS), then again after discharge from BIS (nmFTt3) and finally 4 weeks after discharge from BIS (nmFTt5).
Waiting list group: after baseline interview (t1), the waiting list group will receive standard care for four weeks, then will receive the BIS intervention for another four weeks. Interviews will be held 2 weeks from entering the waiting list group (nmCCt2), prior to commencing BIS (nmCCt3), during BIS (two weeks post-commencing BIS; nmCCt4) and then again after discharge from BIS (four weeks post-commencing BIS (nmCCt5).

Timepoints for malignant group:
Fast-track group: after baseline interview (t1), the fast-track group will receive BIS for two weeks. The measures will be repeated after discharge from BIS (two weeks post-commencement of BIS; mFTt3) and then again two weeks after discharge (mFTt5).
Waiting list group: after baseline interview (t1), the waiting list group will receive standard care for two weeks, then will receive the BIS intervention for another two weeks. Measures will be repeated just prior to commencing BIS (mCCt3) and then again after discharge on from BIS (two weeks post-commencing BIS, mCCt5).

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

Numerical Rating Scale (NRS) distress due to breathlessness.

Time Frame:
Malignant group: 2 weeks after baseline
Non-malignant group: 4 weeks after baseline

Secondary outcome measures

1. Modified Borg
2. NRS breathlessness at best/worst/average
3. Dyspnoea descriptors (patients only)
4. A wellbeing measure
5. Chronic Respiratory Questionnaire (CRQ - patients only)
6. EQ-5D (EuroQoL)
7. Hospital Anxiety Depression Scale
8. Client Service Receipt Inventory
9. Charlton Co-morbidity Index
10. Social functioning item
11. Karnofsky Performance Scale
12. Burden Interview and Caregiver appraisal scale (carer only)
13. Experience of breathlessness and expectations of/views/satisfaction with BIS (qualitative)

Time Frame:
Malignant group: 2 weeks after baseline
Non-malignant group: 4 weeks after baseline

Overall trial start date

01/08/2008

Overall trial end date

30/04/2011

Reason abandoned

Eligibility

Participant inclusion criteria

For patients:
1. Appropriate referral to BIS
2. Aged 18 years or older, either sex
3. Any patient not meeting any exclusion criteria

For carers:
1. Informal carers (significant others, relatives, friends or neighbours) of phase III recruits
2. Aged 18 years or older, either sex
3. Any carer not meeting any exclusion criteria

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120 patients and their carers (60 per group)

Participant exclusion criteria

Patients/carers:
1. Unable to give informed consent
2. Previously used BIS
3. Demented/confused
4. Learning difficulties
5. Other vulnerable groups for example head injury, severe trauma, mental illness
6. Not meeting all inclusion criteria

Recruitment start date

01/08/2008

Recruitment end date

30/04/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

Addenbrooke's Hospital
Box 277
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Sponsor type

Government

Website

http://www.cuh.org.uk/research/research_index.html

Funders

Funder type

Government

Funder name

National Institute for Health Research- Research for Patient Benefit (RfPB) programme (ref: PB-PG-0107-11134)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

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

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21599896
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25358424
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27044249

Publication citations

  1. Protocol

    Farquhar MC, Prevost AT, McCrone P, Higginson IJ, Gray J, Brafman-Kennedy B, Booth S, Study protocol: Phase III single-blinded fast-track pragmatic randomised controlled trial of a complex intervention for breathlessness in advanced disease., Trials, 2011, 12, 130, doi: 10.1186/1745-6215-12-130.

  2. Results

    Farquhar MC, Prevost A, McCrone P, Brafman-Price B, Bentley A, Higginson IJ, Todd C, Booth S, Is a specialist breathlessness service more effective and cost-effective for patients with advanced cancer and their carers than standard care? Findings of a mixed-method randomised controlled trial., BMC Med, 2014, 12, 1, 194, doi: 10.1186/PREACCEPT-1197669166131735.

  3. Results

    Farquhar MC, Prevost AT, McCrone P, Brafman-Price B, Bentley A, Higginson IJ, Todd CJ, Booth S, The clinical and cost effectiveness of a Breathlessness Intervention Service for patients with advanced non-malignant disease and their informal carers: mixed findings of a mixed method randomised controlled trial, Trials, 2016 , 17, 1, 185, doi: 10.1186/s13063-016-1304-6.

Additional files

Editorial Notes

06/04/2016: Publication reference added.