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

ISRCTN ISRCTN04119516
DOI https://doi.org/10.1186/ISRCTN04119516
ClinicalTrials.gov (NCT) NCT00678405
Protocol serial number v2 09/09/08
Sponsor Cambridge University Hospitals NHS Foundation Trust (UK)
Funder National Institute for Health Research- Research for Patient Benefit (RfPB) programme (ref: PB-PG-0107-11134)
Submission date
30/10/2008
Registration date
18/12/2008
Last edited
24/01/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

http://www.cancerhelp.org.uk/trials/a-trial-looking-at-a-service-for-people-who-have-problems-with-breathlessness

Contact information

Mrs Jennifer Gray
Scientific

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

Dr Sara Booth
Scientific

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

Study information

Primary study designInterventional
Study designRandomised controlled phase III (MRC's framework for complex interventions) parallel-assignment single-blind (investigator) trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titlePhase III randomised controlled trial of a breathlessness intervention service for intractable breathlessness
Study acronymPhase III RCT BIS
Study objectivesThe 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(s)Cambridgeshire 2 Research Ethics Committee, July 2008. Substantial amendment submitted in September 2008 and approved October 2008.
Health condition(s) or problem(s) studiedIntractable breathlessness, malignant and non-malignant conditions
InterventionActive 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 typeOther
Primary outcome measure(s)

Numerical Rating Scale (NRS) distress due to breathlessness.

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

Key secondary outcome measure(s)

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

Completion date30/04/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration120
Key inclusion criteriaFor 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
Key exclusion criteriaPatients/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
Date of first enrolment01/08/2008
Date of final enrolment30/04/2011

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 31/10/2014 Yes No
Results article results 04/04/2016 Yes No
Protocol article protocol 20/05/2011 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
Plain English results 24/01/2022 No Yes

Editorial Notes

24/01/2022: A link to plain English results was added.
06/04/2016: Publication reference added.

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