Trial of a Breathlessness Intervention Service for Intractable Breathlessness - Full Text View

Purpose

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:

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

Condition	Intervention	Phase
Dyspnea	Behavioral: Breathlessness Intervention Service Behavioral: Best supportive care (Standard Care)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Supportive Care
Official Title:	Phase III Randomized Controlled Trial of a Breathlessness Intervention Service for Intractable Breathlessness.

Resource links provided by NLM:

MedlinePlus related topics: Breathing Problems Caregivers Palliative Care

U.S. FDA Resources

Further study details as provided by Cambridge University Hospitals NHS Foundation Trust:

Primary Outcome Measures:

Numerical rating Scale (NRS) for distress due to breathlessness [ Time Frame: End of intervention (4 weeks after baseline for patients with a non-malignant diagnosis; 2 weeks after baseline for patients with malignant diagnoses) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Modified BORG [ Time Frame: As for primary outcome measure ] [ Designated as safety issue: No ]
NRS Breathlessness at best/worst [ Time Frame: as for primary outcome measure ] [ Designated as safety issue: No ]
Dyspnoea descriptors [ Time Frame: as for primary outcome measure ] [ Designated as safety issue: No ]
CRQ [ Time Frame: as for primary outcome measure ] [ Designated as safety issue: No ]
EQ-5D [ Time Frame: as for primary outcome measure ] [ Designated as safety issue: No ]
HADS [ Time Frame: as for primary outcome measure ] [ Designated as safety issue: No ]
CSRI [ Time Frame: as for primary outcome measure ] [ Designated as safety issue: No ]
Charlson Co-morbidity score [ Time Frame: as for primary outcome measure ] [ Designated as safety issue: No ]
Social Functioning [ Time Frame: as for primary outcome measure ] [ Designated as safety issue: No ]
Karnofsky [ Time Frame: as for primary outcome measure ] [ Designated as safety issue: No ]
Experience of breathlessness and expectations/views of BIS [ Time Frame: as for primary outcome measure ] [ Designated as safety issue: No ]
Burden interview and caregiver Appr scale [ Time Frame: as for primary outcome measure ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	August 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: WLm / WLnm Best supportive care	Behavioral: Best supportive care (Standard Care) 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. Other Name: Standard care
Experimental: FTm / FTnm Breathlessness Intervention Service	Behavioral: Breathlessness Intervention Service 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). Other Name: BIS

Arms

Assigned Interventions

Active Comparator: WLm / WLnm

Best supportive care

Behavioral: Best supportive care (Standard Care)

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.

Other Name: Standard care

Experimental: FTm / FTnm

Breathlessness Intervention Service

Behavioral: Breathlessness Intervention Service

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).

Other Name: BIS

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient inclusion criteria:

appropriate referral to BIS
aged 18 years+
any patient not meeting any exclusion criteria.

Carer inclusion criteria:

informal carers (significant others, relatives, friends or neighbors) of Phase III RCT recruits
aged 18 years+
any carer not meeting any exclusion criteria.

Exclusion Criteria:

unable to give informed consent
previously used BIS
demented/confused
learning difficulties
other vulnerable groups e.g. head injury, severe trauma, mental illness
not meeting all inclusion criteria.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678405

Contacts

Contact: Sara Booth, FRCP	44-12-2358-6703	sara.booth@addenbrookes.nhs.uk
Contact: Morag C Farquhar, PhD		mcf22@medschl.cam.ac.uk

Locations

United Kingdom
Addenbrooke's Hospital	Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Contact: Sara Booth, FRCP 44-12-2358-6703 sara.booth@addenbrookes.nhs.uk
Contact: Morag C Farquhar, PhD mcf22@medschl.cam.ac.uk

Sponsors and Collaborators

Cambridge University Hospitals NHS Foundation Trust

University of Cambridge

King's College London

Investigators

Principal Investigator:

Sara Booth, FRCP

Cambridge University Hospitals NHS Foundation Trust

More Information

Publications:

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.

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.

Booth S, Wade R. Oxygen or air for palliation of breathlessness in advanced cancer. J R Soc Med. 2003 May;96(5):215-8. Review. No abstract available.

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.

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

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. Epub 2006 Aug 17. Review.

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.

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. Review. Erratum in: Respir Med. 2004 May;98(5):476.

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.

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.

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(1):9 [Epub ahead of print]

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. No abstract available.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Dr Sara Booth, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:	NCT00678405 History of Changes
Other Study ID Numbers:	PB-PG-0107-11134, ISRCTN04119516
Study First Received:	May 14, 2008
Last Updated:	June 24, 2010
Health Authority:	United Kingdom: Research Ethics Committee United Kingdom: National Health Service United Kingdom: Department of Health

Keywords provided by Cambridge University Hospitals NHS Foundation Trust:

Breathlessness
Dyspnoea
Dyspnea
Palliative care
RCT

Randomised controlled trial
Lung cancer
COPD
Heart failure
Chronic respiratory disease

Additional relevant MeSH terms:

Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013