Evaluation of a Multi-professional Breathlessness Service for Patients With Breathlessness Due to Any Advanced Disease (BreathEase)

Ludwig Maximilian University of Munich

Status: Completed

Conditions: Chronic Heart Failure; Cancer; COPD; Breathlessness; Interstitial Lung Disease

Treatments: Other: Delayed MBS Intervention; Other: Multi-professional breathlessness service (MBS)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02622412

01GY1331

Details and patient eligibility

About

Breathlessness is a common and distressing symptom in patients with advanced diseases like cancer, chronic obstructive pulmonary disease (COPD), chronic heart failure (CHF) or lung fibrosis, which broadly impacts on patients' quality of life and may result in high burden for carers.

This single-blinded randomized controlled fast track trial evaluates the effectiveness of a multi-professional breathlessness service in patients with advanced and chronic diseases. The intervention group will get immediate access to the breathlessness service whereas the control group will receive standard care and get access to the service after a waiting time of eight weeks. Primary endpoints are mastery of breathlessness and quality of life, measured with the CRQ (Chronic Respiratory Questionnaire) as well as the reduction of symptom burden of patients and burden of carers. The evaluation of the cost effectiveness of the breathlessness service from the perspective of the German health system is a further study aim.

Enrollment: 183 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients affected by breathlessness due to any advanced life-limiting and progressive disease, despite treatment of the underlying condition and
• Patients capable (in a cognitive and functional manner) to participate in the intervention including outpatient clinic and physiotherapist visits as well as self- management
• If patients are suffering from acute exacerbations of the underlying conditions, they are put on a waiting list for two to four weeks and are then entered into the trial.

Exclusion criteria

• Patients suffering from breathlessness due to chronic hyperventilation syndrome, asthma or any other unknown cause
• Cancer patients under concurrent initial or full dose systemic treatment or radiotherapy (except on maintenance therapy)
• Patients participating in any trial targeting the treatment of underlying conditions/ illness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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183 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Patients randomised to the intervention group will get immediate access to the Multi-professional breathlessness service (MBS).

Treatment:

Other: Multi-professional breathlessness service (MBS)

Control Group

Other group

Description:

Patients randomised to the control group will get delayed MBS intervention. They will receive standard care and get access to the service after a waiting time of eight weeks.

Treatment:

Other: Delayed MBS Intervention