Randomised controlled trial testing the effectiveness of a new multi-professional Breathlessness sErvice for patients with any Advanced diSease against usual care (BreathEase)
- Conditions
- R06J44BreathlessnessC80I50J84J43Abnormalities of breathingOther chronic obstructive pulmonary diseaseMalignant neoplasm, without specification of site
- Registration Number
- DRKS00009318
- Lead Sponsor
- Klinikum der Universität München, Campus Großhadern
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 183
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.
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Mastery of breathlessness <br>2. Quality of life <br>(both measured on the Chronic Respiratory Disease Questionnaire (CRQ))<br>3. Symptom Burden (measured with IPOS)<br>4. Carer burden (Measured with ZBI - 22 item version). <br><br>Measurements are taken at all points in time (Baseline, T1, T2, Follow-up)
- Secondary Outcome Measures
Name Time Method 1.Breathlessness severity <br>2.health economic endpoints, <br>3.survival<br><br>