Breathless Patients With Any Established Underlying Medical Diagnosis Clinical Trial
Official title:
Development,Effectiveness and Cost-effectiveness of a New Respiratory and Palliative Care Out-patient Breathlessness Support Service
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.
| Status | Active, not recruiting |
| Enrollment | 110 |
| Est. completion date | May 2013 |
| Est. primary completion date | October 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 16 Years to 90 Years |
| Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | King's College Hospital | London |
| Lead Sponsor | Collaborator |
|---|---|
| King's College London | King's College Hospital NHS Trust, National Institute for Health Research, United Kingdom |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Chronic Respiratory Disease Questionnaire (CRQ) | The primary outcome measure will be improvement of mastery of breathlessness, as assessed by a change in the score within the Mastery domain of the chronic respiratory disease questionnaire (CRQ). | 12 weeks | No |
| Secondary | Hospital Anxiety and Depression Score | Baseline, 6 and 12 weeks during / after the intervention or usual care | No | |
| Secondary | 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. | Baseline and 12 weeks post intervention or usual care | No | |
| Secondary | 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. | Baseline, 6 and 12 weeks during / after the intervention or usual care | No | |
| Secondary | EQ5D will be used as a generic health related QOL measure. | EQ5D is a standardised instrument for use as a measure of health outcome and is especially suited to cost effectivenessanalyses as it can be used to generate qualityad justed life years (QALYs). It is applicable to a wide range of health conditions and treatments, and provides a simple descriptive profile and a single index value for health status. | Baseline, 6 and 12 weeks during / after the intervention or usual care | No |
| Secondary | A subset of patients (10 patients in each treatment group) will undergo qualitative interviews on expectations, and fears about the service. | Baseline, 6 and 12 weeks during / post intervention or usual care | No | |
| Secondary | Carer burden will be assessed using the Zarit Burden Inventory. | Baseline, 6, and 12 weeks during / post intervention or usual care | No | |
| Secondary | 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 | The CSRI has been used in over 200 studies to assess costs and takes approximately 20 minutes to complete. Services included will be health care (primary and secondary),medication, social care and informal care from family/friends. Lost work time for patients and carers will be recorded. | Baseline, 6 and 12 weeks during / post intervention or usual care | No |
| Secondary | Physiological status will include forced expiratory volume in 1s, slow vital capacity, peak expiratory flow rate (PEF), and pulse oximetry | Baseline, 6 and 12 weeks durning / post intervention or usual care | No | |
| Secondary | 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). | This measure is included because disease severity measured by spirometry alone correlates poorly with breathlessness and functional status in respiratory disease. Assessment of NRD using respiratory muscle electromyography provides a measure of the load on the respiratory system, and inclusion of this parameter will provide insights this test in the future phase III trial. | Baseline, 6 and 12 weeks durning / post intervention or usual care | No |