Clinical trial NCT02622412: Evaluation of a Multi-professional Breathlessness Service for Patients With Breathlessness Due to Any Advanced Disease
Official title: Randomised Controlled Trial Testing the Effectiveness of a New Multi-professional Breathlessness sErvice for Patients With Any Advanced diSease Against Usual Care (BreathEase)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breathlessness
COPD
Cancer
Chronic Heart Failure
Interstitial Lung Disease
Keywords: Quality of Life
Palliative Therapy
Outpatient Services
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: University Hospital Munich
name: Helmholtz Zentrum München
name: University of Cambridge
name: King's College London
First posted: 2015-12-04
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Mastery of breathlessness (CRQ mastery subscale)
timeFrame: From Baseline to Follow-Up (0, 8, 16, 28 weeks)
measure: Quality of Life (CRQ)
timeFrame: From Baseline to Follow-Up (0, 8, 16, 28 weeks)
measure: Symptom Burden (IPOS)
timeFrame: From Baseline to Follow-Up (0, 8, 16, 28 weeks)
measure: Carers' burden of disease (ZBI)
timeFrame: From Baseline to End of Intervention (0, 8, 16 weeks)
Secondary outcomes:
measure: Breathlessness severity (NRS)
timeFrame: From Baseline to Follow-Up (0, 8, 16, 28 weeks)
measure: Generic health-related quality of life (EQ-5D-5L)
timeFrame: From Baseline to Follow-Up (0, 8, 16, 28 weeks)
measure: Costs of health service utilization in Euros
timeFrame: From Baseline to Follow-Up (0, 8, 16, 28 weeks)
measure: Patient survival measured in days
timeFrame: From randomization until death, up to end of study (24 months)
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Hospital of the University of Munich, Department of Palliative Medicine
state: Bavaria
Study officials:
affiliation: Munich University Hospital
name: Claudia Bausewein, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schunk M, Le L, Syunyaeva Z, Haberland B, Tanzler S, Mansmann U, Schwarzkopf L, Seidl H, Streitwieser S, Hofmann M, Muller T, Weiss T, Morawietz P, Rehfuess EA, Huber RM, Berger U, Bausewein C. Effectiveness of a specialised breathlessness service for patients with advanced disease in Germany: a pragmatic fast-track randomised controlled trial (BreathEase). Eur Respir J. 2021 Aug 26;58(2):2002139. doi: 10.1183/13993003.02139-2020. Print 2021 Aug.