Trial of a Breathlessness Intervention Service for Intractable Breathlessness

NCT00678405 | Unknown Phase 3 DMC

• 2 other identifiers: PB-PG-0107-11134ISRCTN04119516
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Is BIS more effective than standard care for patients with intractable breathlessness from advanced malignant or non-malignant disease?
2. 2.Does it reduce patient and carer distress due to breathlessness, and increase patients' sense of mastery of the symptom?
3. 3.What are the experiences and views of those who use BIS, their informal carers and the clinicians who refer to it?
4. 4.Does BIS offer value for money for the NHS?

Conditions

Dyspnea

Keywords

Breathlessness; Dyspnoea; Dyspnea; Palliative care; RCT; Randomised controlled trial; Lung cancer; COPD; Heart failure; Chronic respiratory disease

Outcome Measures

Primary Outcomes (1)

• Numerical rating Scale (NRS) for distress due to breathlessness

  End of intervention (4 weeks after baseline for patients with a non-malignant diagnosis; 2 weeks after baseline for patients with malignant diagnoses)

Secondary Outcomes (12)

• Modified BORG

  As for primary outcome measure

• NRS Breathlessness at best/worst

  as for primary outcome measure

• Dyspnoea descriptors

  as for primary outcome measure

• CRQ

  as for primary outcome measure

• EQ-5D

  as for primary outcome measure

Study Arms (2)

WLm / WLnm

ACTIVE COMPARATOR

Best supportive care

Behavioral: Best supportive care (Standard Care)

FTm / FTnm

EXPERIMENTAL

Breathlessness Intervention Service

Behavioral: Breathlessness Intervention Service

Interventions

Breathlessness Intervention Service BEHAVIORAL

Breathlessness Intervention Service (BIS) consists of a clinical specialist physiotherapist \& palliative care consultant. It aims to manage the symptom of breathlessness in patients with any disease (cancer \& non-cancer) using a rehabilitative approach. Interventions include: evidence-based non-pharmacological interventions (psychological, social \& physical); palliative care input (e.g. end of life issues, psychosocial issues, family concerns); \& pharmacological review. Thus BIS seeks to enhance the self-management of breathlessness. Uniquely, care is located in clinic or in patients' own homes, as appropriate. Referrals come from medical specialists, GPs \& allied health professionals (with medical consent).

Also known as: BIS

FTm / FTnm

Best supportive care (Standard Care) BEHAVIORAL

Standard care: specialist outpatient appointments in secondary care (e.g. respiratory, cardiology, neurology or oncology) which may include specialist nurse input, and primary care services.

Also known as: Standard care

WLm / WLnm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• appropriate referral to BIS
• aged 18 years+

You may not qualify if:

• informal carers (significant others, relatives, friends or neighbors) of Phase III RCT recruits
• aged 18 years+
• unable to give informed consent
• previously used BIS
• demented/confused
• learning difficulties
• other vulnerable groups e.g. head injury, severe trauma, mental illness

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead
• University of Cambridge: collaborator
• King's College London: collaborator

Study Sites (1)

Addenbrooke's Hospital

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

RECRUITING

Related Publications (16)

• Booth 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 BACKGROUND

• Booth 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 BACKGROUND

• Booth 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 BACKGROUND

• Booth 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 BACKGROUND

• Booth S. The management of dyspnoea in advanced cancer. Hosp Med. 1998 May;59(5):348-9. No abstract available.

  PMID: 9722382 BACKGROUND

• Bausewein 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 BACKGROUND

• Bausewein 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 BACKGROUND

• Booth S, Wade R, Johnson M, Kite S, Swannick M, Anderson H; Expert Working Group of the Scientific Committee of the Association of Palliative Medicine. The use of oxygen in the palliation of breathlessness. A report of the expert working group of the Scientific Committee of the Association of Palliative Medicine. Respir Med. 2004 Jan;98(1):66-77. doi: 10.1016/j.rmed.2003.08.008.

  PMID: 14959816 BACKGROUND

• Bredin M, Corner J, Krishnasamy M, Plant H, Bailey C, A'Hern R. Multicentre randomised controlled trial of nursing intervention for breathlessness in patients with lung cancer. BMJ. 1999 Apr 3;318(7188):901-4. doi: 10.1136/bmj.318.7188.901.

  PMID: 10102851 BACKGROUND

• Corner J, Plant H, A'Hern R, Bailey C. Non-pharmacological intervention for breathlessness in lung cancer. Palliat Med. 1996 Oct;10(4):299-305. doi: 10.1177/026921639601000405.

  PMID: 8931065 BACKGROUND

• Farquhar MC, Higginson IJ, Fagan P, Booth S. The feasibility of a single-blinded fast-track pragmatic randomised controlled trial of a complex intervention for breathlessness in advanced disease. BMC Palliat Care. 2009 Jul 7;8:9. doi: 10.1186/1472-684X-8-9.

  PMID: 19583857 BACKGROUND

• Farquhar M, Higginson IJ, Booth S. Fast-track trials in palliative care: an alternative randomized controlled trial design. J Palliat Med. 2009 Mar;12(3):213. doi: 10.1089/jpm.2008.0267. No abstract available.

  PMID: 19254192 BACKGROUND

• 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 Apr 4;17:185. doi: 10.1186/s13063-016-1304-6.

  PMID: 27044249 DERIVED

• Javadzadeh S, Chowienczyk S, Booth S, Farquhar M. Comparison of respiratory health-related quality of life in patients with intractable breathlessness due to advanced cancer or advanced COPD. BMJ Support Palliat Care. 2016 Mar;6(1):105-8. doi: 10.1136/bmjspcare-2015-000949. Epub 2015 Dec 18.

  PMID: 26685116 DERIVED

• Farquhar MC, Prevost AT, 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 Oct 31;12:194. doi: 10.1186/s12916-014-0194-2.

  PMID: 25358424 DERIVED

• 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 May 20;12:130. doi: 10.1186/1745-6215-12-130.

  PMID: 21599896 DERIVED

MeSH Terms

Conditions

Dyspnea; Lung Neoplasms; Pulmonary Disease, Chronic Obstructive; Heart Failure

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sara Booth, FRCP

  Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Booth, FRCP

CONTACT

44-12-2358-6703; sara.booth@addenbrookes.nhs.uk

Morag C Farquhar, PhD

CONTACT

mcf22@medschl.cam.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 14, 2008
• First Posted: May 15, 2008
• Study Start: August 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 25, 2010

Record last verified: 2010-06

Locations

GB (1)