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Randomised controlled trial testing the effectiveness of a new multi-professional Breathlessness sErvice for patients with any Advanced diSease against usual care (BreathEase)

Randomised controlled trial testing the effectiveness of a new multi-professional Breathlessness sErvice for patients with any Advanced diSease against usual care (BreathEase) - BreathEase

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00009318
Enrollment
213
Registered
2015-11-05
Start date
2015-03-02
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breathlessness R06 J44 C80 I50 J84 J43

Interventions

Group 1: Intervention group: a multi-professional breathlessness service (duration 6 weeks) Group 2: Control group: Standard care (followed by attendance of breathlessness service after 8 weeks)

Sponsors

Klinikum der Universität München, Campus Großhadern
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: i) Patients affected by breathlessness due to any advanced life-limiting and progressive disease, despite treatment of the underlying condition ii) Patients capable (in a cognitive and functional manner) to participate in the intervention including outpatient clinic and physiotherapist visits as well as self- management iii) 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

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

Design outcomes

Primary

MeasureTime frame
1. Mastery of breathlessness 2. Quality of life (both measured on the Chronic Respiratory Disease Questionnaire (CRQ)) 3. Symptom Burden (measured with IPOS) 4. Carer burden (Measured with ZBI - 22 item version). Measurements are taken at all points in time (Baseline, T1, T2, Follow-up)

Secondary

MeasureTime frame
1. Breathlessness severity 2. health economic endpoints, 3. survival

Countries

Germany

Contacts

Public ContactMichaela Schunk

Klinik und Poliklinik für Palliativmedizin, Klinikum der Universität München, Campus Großhadern

michaela.schunk@med.uni-muenchen.de0049 89 4400 77946

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026