Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Development,Effectiveness and Cost-effectiveness of a New Respiratory and Palliative Care Out-patient Breathlessness Support Service
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.


Options:
A: Arm Label: Tool + Self-management Support Program; Type: EXPERIMENTAL; Interventions: Device: Tool, Behavioral: Self-management Support Program | Arm Label: Self- management Support Program; Type: EXPERIMENTAL; Interventions: Behavioral: Self-management Support Program | Arm Label: Care as usual; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: Tool; Assigned to Arm(s): Tool + Self-management Support Program | Intervention Type: BEHAVIORAL; Name: Self-management Support Program; Assigned to Arm(s): Self- management Support Program, Tool + Self-management Support Program
B: Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Education Intervention; Type: ACTIVE_COMPARATOR; Interventions: Other: Introductory Disease Education | Intervention Type: OTHER; Name: Introductory Disease Education; Assigned to Arm(s): Education Intervention
C: Arm Label: Usual care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Breathlessness Support Service; Type: EXPERIMENTAL; Interventions: Other: Breathlessness Support Service | Intervention Type: OTHER; Name: Breathlessness Support Service; Assigned to Arm(s): Breathlessness Support Service
D: Arm Label: Group 1; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Group 2; Type: EXPERIMENTAL; Interventions: Behavioral: COPD Self-management Education | Intervention Type: BEHAVIORAL; Name: COPD Self-management Education; Assigned to Arm(s): Group 2

Answer: C