Phase III randomised controlled trial of a breathlessness intervention service for intractable breathlessness
| ISRCTN | ISRCTN04119516 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04119516 |
| ClinicalTrials.gov number | NCT00678405 |
| Secondary identifying numbers | v2 09/09/08 |
- 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
Contact information
Mrs Jennifer Gray
Scientific
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
Scientific
Addenbrooke's Hospital
Cambridge University Hospitals NHS Foundation Trust
Palliative Care Box 193
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information material can be found at: http://www.cancerhelp.org.uk/trials/trials/trial.asp?=&trialno=15866 |
| Scientific title | Phase III randomised controlled trial of a breathlessness intervention service for intractable breathlessness |
| Study 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(s) | Cambridgeshire 2 Research Ethics Committee, July 2008. Substantial amendment submitted in September 2008 and approved October 2008. |
| 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 |
| Primary outcome measure | 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 study start date | 01/08/2008 |
| Overall study end date | 30/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 patients and their carers (60 per group) |
| 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 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
- England
- United Kingdom
Study participating centre
Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom
CB2 0QQ
United Kingdom
Sponsor information
Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Addenbrooke's Hospital
Box 277
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom
| Website | http://www.cuh.org.uk/research/research_index.html |
|---|---|
"ROR" |
https://ror.org/04v54gj93 |
Funders
Funder type
Government
National Institute for Health Research- Research for Patient Benefit (RfPB) programme (ref: PB-PG-0107-11134)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 20/05/2011 | Yes | No | |
| Results article | results | 31/10/2014 | Yes | No | |
| Results article | results | 04/04/2016 | Yes | No | |
| 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.
