Dyspnea | Trial of a Breathlessness Intervention Service for Intractable Breathlessness
Dyspnea research study
What is the primary objective of this study?
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?
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Behavioral:Breathlessness Intervention ServiceBreathlessness Intervention Service (BIS) consists of a clinical specialist physiotherapist
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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
WLm / WLnmBest supportive care
FTm / FTnmBreathlessness Intervention Service
Start Date: August 2008
Completed Date: December 2010
Phase: Phase 3
Primary Outcome: Numerical rating Scale (NRS) for distress due to breathlessness
Secondary Outcome: Modified BORG
Study sponsors, principal investigator, and references
Principal Investigator: Sara Booth, FRCP
Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust
Collaborator: University of Cambridge
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.