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

Phase 3

Completed

• Conditions: Intractable breathlessness, malignant and non-malignant conditions; Respiratory; Abnormalities of breathing

• Registration Number: ISRCTN04119516
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust (UK)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-12-18
• Study Completion: 2011-04-30
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Numerical Rating Scale (NRS) distress due to breathlessness.<br><br> Time Frame:<br> Malignant group: 2 weeks after baseline<br> Non-malignant group: 4 weeks after baseline<br>

Secondary Outcome Measures

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