Clinical trial NCT01165034: Development of King's College Hospital Breathlessness Service
Official title: Development,Effectiveness and Cost-effectiveness of a New Respiratory and Palliative Care Out-patient Breathlessness Support Service
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breathless Patients With Any Established Underlying Medical Diagnosis
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: King's College Hospital NHS Trust
First posted: 2010-07-19
Enrollment: 110
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Breathlessness is a common, distressing symptom in advanced malignant and non malignant disease, and impacts significantly on quality of life. Breathlessness in end stage disease is also responsible for significant healthcare resource usage. Escalante \[1\] reported hospital admission rates of 60% in patients presenting to a cancer treatment centre with breathlessness. Preliminary trials of breathlessness clinics with selected groups of patients have been promising, but lack data on their cost effectiveness.

The principal aim of the research is to develop and evaluate the effectiveness and cost effectiveness of a multidisciplinary outpatient breathlessness support service (BSS) for the palliation of breathlessness, in advanced malignant and non malignant disease. This is a phase II study that aims to test the hypothesis that a BSS will improve patient mastery over breathlessness and reduce the use of healthcare resources (including GP consultations,accident and emergency attendances, and length of hospital stay) compared with usual best medical care alone (UC),at an acceptable level of cost effectiveness.The outcomes of this study will also help to determine sample size,develop and test methods for a phase III trial that will follow on from this project.

This study will run over 2 years. Breathless patients with advanced malignant and non malignant disease who have already been optimally medically managed will be eligible.

The service will be run in the outpatient department of King's College Hospital, and patients will also be assessed in their own home and by telephone interviews. At baseline we will assess respiratory function and breathlessness mastery and severity using validated scales, and health service usage. Individuals will be randomised to the intervention group \[IG\] (n=55) or UC (n=55). The IG will attend the new outpatient clinical service with multiprofessional input. Assessments will be repeated at 4, 10 \& 24 weeks.

1.Escalante, C.P., Martin, C.G., Elting, L.S. et al., Dyspnea in cancer patients. Etiology, resource utilization, and survival implications in a managed care world. Cancer, 1996. 78(6): p. 13149.


Eligibility criteria: Inclusion Criteria:

* Patients with any established underlying medical diagnosis with breathlessness on exertion or at rest.
* Cancer patients who have risk factors for breathlessness( risk factors include a history of smoking, asthma or COPD, lung irradiation, exposure to asbestos, coal dust, cotton dust or grain dust, lung involvement by cancer)
* Respiratory muscle weakness
* Anxiety.
* Patients must have advanced disease that is refractory to maximal optimised medical management. - Patients must be able to engage with a short term physiotherapy and occupational therapy intervention.

Exclusion Criteria:

* Patients with breathlessness of unknown cause.
* Chronic hyperventilation syndrome.

Primary outcomes:
measure: Chronic Respiratory Disease Questionnaire (CRQ)
timeFrame: 12 weeks
Secondary outcomes:
measure: Hospital Anxiety and Depression Score
timeFrame: Baseline, 6 and 12 weeks during / after the intervention or usual care
measure: A Numerical Rating Scale (NRS) to assess the intensity of the sensation of breathlessness on average and at worst at rest and on exertion over the last 24 hours.
timeFrame: Baseline and 12 weeks post intervention or usual care
measure: Symptom related quality of life(QOL) will also be assessed using the Palliative Care Outcome Scale (POS) and POS symptoms to quantify palliative care symptoms in addition to breathlessness.
timeFrame: Baseline, 6 and 12 weeks during / after the intervention or usual care
measure: EQ5D will be used as a generic health related QOL measure.
timeFrame: Baseline, 6 and 12 weeks during / after the intervention or usual care
measure: A subset of patients (10 patients in each treatment group) will undergo qualitative interviews on expectations, and fears about the service.
timeFrame: Baseline, 6 and 12 weeks during / post intervention or usual care
measure: Carer burden will be assessed using the Zarit Burden Inventory.
timeFrame: Baseline, 6, and 12 weeks during / post intervention or usual care
measure: The Client Service Receipt Inventory (CSRI) will be used to record other service use in the three month period prior to baseline assessment and then for each followup period
timeFrame: Baseline, 6 and 12 weeks during / post intervention or usual care
measure: Physiological status will include forced expiratory volume in 1s, slow vital capacity, peak expiratory flow rate (PEF), and pulse oximetry
timeFrame: Baseline, 6 and 12 weeks durning / post intervention or usual care
measure: Respiratory muscle activity will also be measured noninvasively by quantifying the surface parasternal intercostal muscle electromyogram, to provide an index of neural respiratory drive (NRD).
timeFrame: Baseline, 6 and 12 weeks durning / post intervention or usual care
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
affiliation: King's College London
name: John Moxham, MD FRCP
role: STUDY_DIRECTOR
affiliation: King's College London
name: Irene Higginson, BMedSci BMBS PhD FFPHM FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Higginson IJ, Bausewein C, Reilly CC, Gao W, Gysels M, Dzingina M, McCrone P, Booth S, Jolley CJ, Moxham J. An integrated palliative and respiratory care service for patients with advanced disease and refractory breathlessness: a randomised controlled trial. Lancet Respir Med. 2014 Dec;2(12):979-87. doi: 10.1016/S2213-2600(14)70226-7. Epub 2014 Oct 29.
citation: Bausewein C, Jolley C, Reilly C, Lobo P, Kelly J, Bellas H, Madan P, Panell C, Brink E, De Biase C, Gao W, Murphy C, McCrone P, Moxham J, Higginson IJ. Development, effectiveness and cost-effectiveness of a new out-patient Breathlessness Support Service: study protocol of a phase III fast-track randomised controlled trial. BMC Pulm Med. 2012 Sep 19;12:58. doi: 10.1186/1471-2466-12-58.