Development of King's College Hospital Breathlessness Service

King's College London

Status and phase: Unknown; Phase 3

Conditions: Breathless Patients With Any Established Underlying Medical Diagnosis

Treatments: Other: Breathlessness Support Service

Study type: Interventional

Funder types: Other

Identifiers

NCT01165034

10/H0808/17

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 16 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Usual care

No Intervention group

Description:

Best usual practice including general respiratory specialist and primary care

Breathlessness Support Service

Experimental group

Description:

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.

Treatment:

Other: Breathlessness Support Service