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Trial of a Breathlessness Intervention Service for Intractable Breathlessness
This study is currently recruiting participants.
Verified by Cambridge University Hospitals NHS Foundation Trust, January 2009
Sponsors and Collaborators: Cambridge University Hospitals NHS Foundation Trust
University of Cambridge
King's College London
Information provided by: Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00678405
  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:

  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?

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

MedlinePlus related topics: Breathing Problems Palliative Care
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Single Blind (Investigator), Parallel Assignment, Efficacy Study
Official Title: Phase III Randomized Controlled Trial of a Breathlessness Intervention Service for Intractable Breathlessness.

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; NRS breathlessness at best/worst; dyspnoea descriptors; CRQ; EQ-5D; HADS; CSRI; Charlson Co-morbidity Index; social functioning; Karnofsky; experience of breathlessness & expectations/views of BIS; Burden Interview & 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: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
WLm / WLnm: Active Comparator
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.
FTm / FTnm: Experimental
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).

  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:

  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.
  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, Cambridgeshire
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.

Responsible Party: Cambridge University Hospitals NHS Foundation Trust ( Dr Sara Booth )
Study ID Numbers: PB-PG-0107-11134, ISRCTN04119516
Study First Received: May 14, 2008
Last Updated: January 5, 2009
ClinicalTrials.gov Identifier: NCT00678405  
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

Study placed in the following topic categories:
Signs and Symptoms
Heart Failure
Respiratory Tract Diseases
Lung Neoplasms
 Respiration Disorders
Signs and Symptoms, Respiratory
Dyspnea

ClinicalTrials.gov processed this record on January 15, 2009



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