Clinical trial · Interventional
Trial of a Breathlessness Intervention Service for Intractable Breathlessness
Phase III Randomized Controlled Trial of a Breathlessness Intervention Service for Intractable Breathlessness.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to evaluate the impact of a Breathlessness Intervention Service (BIS) on the quality of life of patients and families affected by intractable breathlessness. The questions to be addressed by this 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. Does BIS offer value for money for the NHS?
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dyspnea | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best supportive care (Standard Care) | Behavioral | — | UNRESOLVED |
| Breathlessness Intervention Service | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- WLm / WLnm
- description
- Best supportive care
- interventionNames
- Behavioral: Best supportive care (Standard Care)
- type
- EXPERIMENTAL
- label
- FTm / FTnm
- description
- Breathlessness Intervention Service
- interventionNames
- Behavioral: Breathlessness Intervention Service
Primary outcomes (1)
- measure
- Numerical rating Scale (NRS) for distress due to breathlessness
- timeFrame
- End of intervention (4 weeks after baseline for patients with a non-malignant diagnosis; 2 weeks after baseline for patients with malignant diagnoses)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Patient inclusion criteria: 1. appropriate referral to BIS 2. aged 18 years+ 3. any patient not meeting any exclusion criteria. Carer inclusion criteria: 1. informal carers (significant others, relatives, friends or neighbors) of Phase III RCT recruits 2. aged 18 years+ 3. any carer not meeting any exclusion criteria. Exclusion Criteria: 1. unable to give informed consent 2. previously used BIS 3. demented/confused 4. learning difficulties 5. other vulnerable groups e.g. head injury, severe trauma, mental illness 6. not meeting all inclusion criteria.
References
Publications (16)
- BACKGROUNDBooth S, Silvester S, Todd C. Breathlessness in cancer and chronic obstructive pulmonary disease: using a qualitative approach to describe the experience of patients and carers. Palliat Support Care. 2003 Dec;1(4):337-44. doi: 10.1017/s1478951503030499. PMID 16594223
- BACKGROUNDBooth S, Farquhar M, Gysels M, Bausewein C, Higginson IJ. The impact of a breathlessness intervention service (BIS) on the lives of patients with intractable dyspnea: a qualitative phase 1 study. Palliat Support Care. 2006 Sep;4(3):287-93. doi: 10.1017/s1478951506060366. PMID 17066970
- BACKGROUNDBooth S, Wade R. Oxygen or air for palliation of breathlessness in advanced cancer. J R Soc Med. 2003 May;96(5):215-8. doi: 10.1177/014107680309600503. No abstract available. PMID 12724429
- BACKGROUNDBooth S, Adams L. The shuttle walking test: a reproducible method for evaluating the impact of shortness of breath on functional capacity in patients with advanced cancer. Thorax. 2001 Feb;56(2):146-50. doi: 10.1136/thorax.56.2.146. PMID 11209105
- BACKGROUNDBooth S. The management of dyspnoea in advanced cancer. Hosp Med. 1998 May;59(5):348-9. No abstract available. PMID 9722382
- BACKGROUNDBausewein C, Farquhar M, Booth S, Gysels M, Higginson IJ. Measurement of breathlessness in advanced disease: a systematic review. Respir Med. 2007 Mar;101(3):399-410. doi: 10.1016/j.rmed.2006.07.003. Epub 2006 Aug 17. PMID 16914301
- BACKGROUNDBausewein C, Booth S, Gysels M, Higginson I. Non-pharmacological interventions for breathlessness in advanced stages of malignant and non-malignant diseases. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD005623. doi: 10.1002/14651858.CD005623.pub2. PMID 18425927