Pilot Randomized Controlled Trial of a Breathlessness Intervention Service for Chronic Obstructive Pulmonary Disease - Full Text View

Sponsors and Collaborators:	Cambridge University Hospitals NHS Foundation Trust King's College London
Information provided by:	Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:	NCT00711438

Purpose

The aim of this study is to test the feasibility of conducting a pragmatic fast track Randomized Controlled Trial (RCT) of the Breathlessness Intervention Service (BIS) versus standard care for patients with COPD and their carers, and to begin testing the effectiveness of the intervention.

Condition	Intervention	Phase
Dyspnea	Behavioral: Breathlessness Intervention Service (BIS) Behavioral: Best supportive care (Standard care)	Phase II

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Phase II Pilot Pragmatic Single-Blinded Fast Track Randomised Controlled Trial of the Breathlessness Intervention Service Versus Standard Care for Patients With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:

MedlinePlus related topics: Breathing Problems COPD (Chronic Obstructive Pulmonary Disease) Palliative Care

U.S. FDA Resources

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

Primary Outcome Measures:

Visual Analogue Scale (VAS) - distress due to breathlessness [ Time Frame: End of intervention (8 weeks after baseline) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Modified BORG [ Time Frame: As for primary outcome measure ] [ Designated as safety issue: No ]
VAS breathlessness at best /worst [ Time Frame: As for primary outcome measure ] [ Designated as safety issue: No ]
Mastery scale of CRQ [ Time Frame: As for primary outcome measure ] [ Designated as safety issue: No ]
SEIQoL-DW [ 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 ]
social functioning [ Time Frame: As for primary outcome measure ] [ Designated as safety issue: No ]
WHO Performance scale [ Time Frame: As for primary outcome measure ] [ Designated as safety issue: No ]
experience of breathlessness & expectations / views of BIS [ Time Frame: As for primary outcome measure ] [ Designated as safety issue: No ]
Carer Burden Interview and Caregiver Appraisal Scale [ Time Frame: As for primary outcome measure ] [ Designated as safety issue: No ]

Enrollment:	13
Study Start Date:	April 2006
Study Completion Date:	April 2007
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
FT: Experimental Breathlessness Intervention Service (BIS)	Behavioral: Breathlessness Intervention Service (BIS) BIS consists of a clinical specialist physiotherapist & 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 & physical); palliative care input (e.g. end of life issues, psychosocial issues, family concerns); & pharmacological review. This BIS seeks to enhance 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).
WL: Active Comparator Best supportive care	Behavioral: Best supportive care (Standard care) Standard care: specialist outpatient appointments in secondary care (e.g. respiratory) which may include specialist nurse input, and primary care services.

Arms

Assigned Interventions

FT: Experimental

Breathlessness Intervention Service (BIS)

Behavioral: Breathlessness Intervention Service (BIS)

BIS consists of a clinical specialist physiotherapist & 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 & physical); palliative care input (e.g. end of life issues, psychosocial issues, family concerns); & pharmacological review. This BIS seeks to enhance 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).

WL: Active Comparator

Best supportive care

Behavioral: Best supportive care (Standard care)

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

Show Detailed Description

Eligibility

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

Criteria

Inclusion Criteria:

Patients:

Appropriate referral to the BIS
Diagnosis of COPD/COAD
Aged 18 years or over
Any patient who does not meet any of the exclusion criteria

Carers:

The informal carers of patients specified above, who can be significant others, relatives, friends or neighbours
Aged 18 years or over
Any carer who does not meet the exclusion criteria

Exclusion Criteria:

Any patient/carer unable to give informed consent
Any patient living outside of Cambridgeshire PCT, West Essex PCT, East & North Hertfordshire PCT, or Suffolk PCT
Any patient who has previously had access to BIS
Any patient/carer who is demented or confused
Any patient/carer with learning difficulties
Any patient/carer from other vulnerable groups (e.g. head injury, severe trauma, and mental illness)
Any patient/carer who does not meet all of the inclusion criteria

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711438

Locations

United Kingdom, Cambridgeshire
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ

Sponsors and Collaborators

Cambridge University Hospitals NHS Foundation Trust

King's College London

Investigators

Principal Investigator:

Sara Booth, FRCP

Cambridge University Hopsitals 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.

Responsible Party:	Cambridge University Hospitals NHS Foundation Trust ( Dr Sara Booth )
Study ID Numbers:	BIS PhIInm v3 26/10/06
Study First Received:	July 3, 2008
Last Updated:	July 7, 2008
ClinicalTrials.gov Identifier:	NCT00711438 History of Changes
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
COPD
Chronic respiratory disease

Study placed in the following topic categories:

Signs and Symptoms
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Respiration Disorders
Signs and Symptoms, Respiratory
Dyspnea
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Signs and Symptoms
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Respiration Disorders
Signs and Symptoms, Respiratory
Dyspnea
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on September 11, 2009