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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?

Dyspnea

Study Interventions

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.

Study Arms

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

Study Status

Unknown status

Start Date: August 2008

Completed Date: December 2010

Phase: Phase 3

Type: Interventional

Design:

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

More information:https://clinicaltrials.gov/show/NCT00678405

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.

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