Overview

This trial is active, not recruiting.

Condition breathless patients with any established underlying medical diagnosis
Treatment breathlessness support service
Phase phase 3
Sponsor King's College London
Collaborator National Institute for Health Research, United Kingdom
Start date July 2010
End date October 2012
Trial size 110 participants
Trial identifier NCT01165034, 10/H0808/17

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(No Intervention)
Best usual practice including general respiratory specialist and primary care
(Experimental)
Patients randomised to the intervention group (IG) will be entered into the BSS in addition to standard best usual care. Expertise in the BSS will comprise of a palliative care consultant or specialist registrar (SpR), a respiratory medicine consultant or SpR with a specialist interest in breathlessness, a respiratory physiotherapist, an occupational therapist and a respiratory nurse specialist. Patients will see 12 health professionals per visit, and multidisciplinary team meetings will take place before and after each visit. Outpatient clinics will take place once per week. The timing of interventions and data collection has been designed to allow for short disease trajectories in patients with cancer and minimise patient burden, whilst allowing time for interventions to have the desired effect. Four weeks is considered to be the minimum length of pulmonary rehabilitation programmes that give a clinically significant benefit.
breathlessness support service
Patients randomised to the intervention group (IG) will be entered into the BSS in addition to standard best usual care. Expertise in the BSS will comprise of a palliative care consultant or specialist registrar (SpR), a respiratory medicine consultant or SpR with a specialist interest in breathlessness, a respiratory physiotherapist, an occupational therapist and a respiratory nurse specialist. Patients will see 12 health professionals per visit, and multidisciplinary team meetings will take place before and after each visit. Outpatient clinics will take place once per week. The timing of interventions and data collection has been designed to allow for short disease trajectories in patients with cancer and minimise patient burden, whilst allowing time for interventions to have the desired effect. Four weeks is considered to be the minimum length of pulmonary rehabilitation programmes that give a clinically significant benefit.

Primary Outcomes

Measure
Chronic Respiratory Disease Questionnaire (CRQ)
time frame: 12 weeks

Secondary Outcomes

Measure
Hospital Anxiety and Depression Score
time frame: Baseline, 6 and 12 weeks during / after the intervention or usual care
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.
time frame: Baseline and 12 weeks post intervention or usual care
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.
time frame: Baseline, 6 and 12 weeks during / after the intervention or usual care
EQ5D will be used as a generic health related QOL measure.
time frame: Baseline, 6 and 12 weeks during / after the intervention or usual care
A subset of patients (10 patients in each treatment group) will undergo qualitative interviews on expectations, and fears about the service.
time frame: Baseline, 6 and 12 weeks during / post intervention or usual care
Carer burden will be assessed using the Zarit Burden Inventory.
time frame: Baseline, 6, and 12 weeks during / post intervention or usual care
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
time frame: Baseline, 6 and 12 weeks during / post intervention or usual care
Physiological status will include forced expiratory volume in 1s, slow vital capacity, peak expiratory flow rate (PEF), and pulse oximetry
time frame: Baseline, 6 and 12 weeks durning / post intervention or usual care
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).
time frame: Baseline, 6 and 12 weeks durning / post intervention or usual care

Eligibility Criteria

Male or female participants from 16 years up to 90 years old.

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.

Additional Information

Official title Development,Effectiveness and Cost-effectiveness of a New Respiratory and Palliative Care Out-patient Breathlessness Support Service
Principal investigator Irene Higginson, BMedSci BMBS PhD FFPHM FRCP
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by King's College London.