NCT00711438

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 8, 2008

Completed
Last Updated

July 8, 2008

Status Verified

October 1, 2006

Enrollment Period

1 year

First QC Date

July 3, 2008

Last Update Submit

July 7, 2008

Conditions

Dyspnea

Keywords

BreathlessnessDyspnoeaDyspneaPalliative careRCTRandomised controlled trialCOPDChronic respiratory disease

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale (VAS) - distress due to breathlessness

    End of intervention (8 weeks after baseline)

Secondary Outcomes (9)

  • Modified BORG

    As for primary outcome measure

  • VAS breathlessness at best /worst

    As for primary outcome measure

  • Mastery scale of CRQ

    As for primary outcome measure

  • SEIQoL-DW

    As for primary outcome measure

  • HADS

    As for primary outcome measure

  • +4 more secondary outcomes

Study Arms (2)

FT

EXPERIMENTAL

Breathlessness Intervention Service (BIS)

Behavioral: Breathlessness Intervention Service (BIS)

WL

ACTIVE COMPARATOR

Best supportive care

Behavioral: Best supportive care (Standard care)

Interventions

Breathlessness Intervention Service (BIS)BEHAVIORAL

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).

Also known as: BIS
FT
Best supportive care (Standard care)BEHAVIORAL

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

Also known as: Standard care
WL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients:
  • Appropriate referral to the BIS
  • Diagnosis of COPD/COAD
  • Aged 18 years or over

You may not qualify if:

  • Carers:
  • The informal carers of patients specified above, who can be significant others, relatives, friends or neighbours
  • Aged 18 years or over
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Addenbrooke's Hospital

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Related Publications (9)

  • 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: 16594223BACKGROUND

  • 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: 17066970BACKGROUND

  • 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: 12724429BACKGROUND

  • 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: 11209105BACKGROUND

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

    PMID: 9722382BACKGROUND

  • 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: 16914301BACKGROUND

  • 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: 18425927BACKGROUND

  • 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: 14959816BACKGROUND

  • 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: 19583857DERIVED

MeSH Terms

Conditions

DyspneaPulmonary Disease, Chronic Obstructive

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsLung Diseases, ObstructiveLung DiseasesChronic DiseaseDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Sara Booth, FRCP

    Cambridge University Hopsitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 3, 2008

First Posted

July 8, 2008

Study Start

April 1, 2006

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

July 8, 2008

Record last verified: 2006-10

Locations

GB(1)