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Trial of a Breathlessness Intervention Service for Intractable Breathlessness

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Cambridge University Hospitals NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Cambridge
King's College London
Information provided by:
Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00678405
First received: May 14, 2008
Last updated: June 24, 2010
Last verified: June 2010
  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 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:


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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on November 25, 2014