BreathlessnessBreathEaseNCT02622412
Evaluation of a Multi-professional Breathlessness Service for Patients With Breathlessness Due to Any Advanced Disease
A study testing Multi-professional breathlessness service (MBS) and Delayed MBS Intervention in people with Breathlessness and COPD, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breathlessness, COPD, Cancer
- What is being tested?
- Multi-professional breathlessness service (MBS) and Delayed MBS Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteGermany
- Study dates
- 2 Mar 2015to 30 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site
Hospital of the University of Munich, Department of Palliative Medicine
Munich, Bavaria, 81377
About this study
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)
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.
- Conditions
- Breathlessness, COPD, Cancer, Chronic Heart Failure, Interstitial Lung Disease
- Being tested
- Multi-professional breathlessness service (MBS), Delayed MBS Intervention
- Keywords
- Quality of Life, Palliative Therapy, Outpatient Services
- Medical subject headings
- Dyspnea, Pulmonary Disease, Chronic Obstructive, Neoplasms, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-professional breathlessness service (MBS)Other
Patients visit the MBS twice. At week 1, delivered by palliative care specialists and respiratory disease specialists, patients receive an detailed assessment of breathlessness, relevant symptoms beyond breathlessness, psychosocial issues and carer burden. Recommendations are provided, and reviewed at the concluding visit in week 6 with palliative care specialists. In between these visits, weekly physiotherapy sessions focus on positioning, breathing techniques, exercise as well as pacing and fatigue management. Further support from the multi-professional expert team is given as needed.
Delayed MBS InterventionOther
Patients will wait 8 weeks for start of intervention and will receive standard care in the meantime with access to respiratory medicine, general practitioners and palliative care services as needed. Standard care includes support by their general practitioners and disease orientated treatment (e.g. anti-obstructive treatment, oxygen supply if indicated, chemotherapy).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Patients randomised to the intervention group will get immediate access to the Multi-professional breathlessness service (MBS). Receives: Other: Multi-professional breathlessness service (MBS) |
| Control Group | Other | 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. Receives: Other: Delayed MBS Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mastery of breathlessness (CRQ mastery subscale)
Change from baseline in Mastery of breathlessness (at week 8) measured with the Chronic Respiratory Disease Questionnaire (CRQ) in a face-to-face interview. Mastery represents one of the four CRQ domains containing 4 items. Patients rate their experience on each item a 7-point scale ranging from 1 (maximum impairment) to 7 (no impairment). The subscale "Mastery" is calculated by averaging the scores of the 4 items belonging to this subscale.
Measured: From Baseline to Follow-Up (0, 8, 16, 28 weeks)
Quality of Life (CRQ)
Change from baseline in Quality of Life (at week 8) measured with the CRQ. The CRQ contains 20 items across four domains: dyspnea, fatigue, emotional function, and mastery. Quality of life is calculated by adding all responses to all 20 items. Patients rate their experience on each item a 7-point scale ranging from 1 (maximum impairment) to 7 (no impairment)
Measured: From Baseline to Follow-Up (0, 8, 16, 28 weeks)
Symptom Burden (IPOS)
Change from baseline in palliative care needs and specific symptoms (at week 8) assessed with the Integrated Palliative Care Outcome Scale (IPOS). The IPOS includes 10 symptoms and 7 questions on patients and carers emotional situation, spiritual concerns, and provision of information and support. The overall profile score is the sum of the scores from each of the 17 questions.
Measured: From Baseline to Follow-Up (0, 8, 16, 28 weeks)
Carers' burden of disease (ZBI)
Change from baseline in carers' burden (at week 8) assessed with the Zarit Burden Inventory (ZBI), measuring personal strain and role strain. The revised version contains 22 items. Each item is a statement which the carer is asked to endorse using a 5-point scale. Response options range from 0 (never) to 4 (nearly always).
Measured: From Baseline to End of Intervention (0, 8, 16 weeks)
Secondary outcomes (4)
Breathlessness severity (NRS)
Change from baseline in breathlessness severity (at week 8) measured with numerical rating scales (NRS). The NRS will be used to assess breathlessness over the last 24 hours on average,at rest and on exercise. Responses on a rating scale range from 1 (no breathlessness) to 10 (strongest imaginable breathlessness).
Measured: From Baseline to Follow-Up (0, 8, 16, 28 weeks)
Generic health-related quality of life (EQ-5D-5L)
Change from baseline in patients' generic health-related quality of life measured with the EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L). The EQ-5D-5L essentially consists of 2 pages - the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogue scale of the EQ-5D-5L questionnaire ranges from 0 to 100 (with 0 representing the worst health the patient can imagine and 100 representing the best health the patient can imagine). Value sets of the EuroQol Group by time trade-off (TTO) will be used for scoring algorithm.
The EQ-5D-5L is a standardized instrument applicable to a wide range of health conditions for use as a measure of health and is especially suited to cost effectiveness analyses.
Measured: From Baseline to Follow-Up (0, 8, 16, 28 weeks)
Costs of health service utilization in Euros
Mean costs of intervention and control group (excluding study related costs) will be estimated. To calculate sum of costs in Euros per group to receive one aggregated outcome, firstly the following resource use data will be collected: Outpatient care, Medication, Medical aids, Inpatient care, Nursing home/hospice, Rehabilitation, Remedies (physiotherapy, massage, other), Formal care, Home help, Informal care, Work absenteeism, and early retirement. Secondly, resource use categories will be monetarily valued using unit cost and multiplied with the collected amount of resource use. Thirdly, mean costs in Euros per group will be calculated.
Measured: From Baseline to Follow-Up (0, 8, 16, 28 weeks)
Patient survival measured in days
Survival is defined as time from randomization to death irrespective of the cause of death. Participants who will not die during study course will be censored at the time of last contact which is planned for week 28 after last patient in. Survival status will be assessed by phone for all participants.
Measured: From randomization until death, up to end of study (24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study start2 Mar 2015
- Primary completion1 Feb 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreathlessnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Munich, Helmholtz Zentrum München, University of Cambridge, King's College London
- Responsible party
- Principal investigator, Claudia Bausewein, Ludwig-Maximilians - University of Munich
- Investigators
- Claudia Bausewein, Prof.Dr.med., Principal investigator, Munich University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622412
- Sponsor's protocol ID
- 01GY1331
- Acronym
- BreathEase
- Status last verified
- Aug 2019
- First submitted
- 31 Oct 2015
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33509957
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02622412
- Acronym / sponsor ID
- BreathEase / 01GY1331
- Conditions
- Breathlessness, COPD, Cancer, Chronic Heart Failure, Interstitial Lung Disease
- Keywords
- Quality of Life, Palliative Therapy, Outpatient Services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- University Hospital Munich, Helmholtz Zentrum München, University of Cambridge, King's College London
- Study start
- 2 Mar 2015 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 4 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Multi-professional breathlessness service (MBS)Patients randomised to the intervention group will get immediate access to the Multi-professional breathlessness service (MBS). |
| Control Group | Other | Other: Delayed MBS InterventionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-professional breathlessness service (MBS)Patients visit the MBS twice. At week 1, delivered by palliative care specialists and respiratory disease specialists, patients receive an detailed assessment of breathlessness, relevant symptoms beyond breathlessness, psychosocial issues and carer burden. Recommendations are provided, and reviewed at the concluding visit in week 6 with palliative care specialists. In between these visits, weekly physiotherapy sessions focus on positioning, breathing techniques, exercise as well as pacing and fatigue management. Further support from the multi-professional expert team is given as needed. | Other | Intervention Group |
| Delayed MBS InterventionPatients will wait 8 weeks for start of intervention and will receive standard care in the meantime with access to respiratory medicine, general practitioners and palliative care services as needed. Standard care includes support by their general practitioners and disease orientated treatment (e.g. anti-obstructive treatment, oxygen supply if indicated, chemotherapy). | Other | Control Group |
Primary outcome
Mastery of breathlessness (CRQ mastery subscale)
Time frame: From Baseline to Follow-Up (0, 8, 16, 28 weeks)
Change from baseline in Mastery of breathlessness (at week 8) measured with the Chronic Respiratory Disease Questionnaire (CRQ) in a face-to-face interview. Mastery represents one of the four CRQ domains containing 4 items. Patients rate their experience on each item a 7-point scale ranging from 1 (maximum impairment) to 7 (no impairment). The subscale "Mastery" is calculated by averaging the scores of the 4 items belonging to this subscale.
Quality of Life (CRQ)
Time frame: From Baseline to Follow-Up (0, 8, 16, 28 weeks)
Change from baseline in Quality of Life (at week 8) measured with the CRQ. The CRQ contains 20 items across four domains: dyspnea, fatigue, emotional function, and mastery. Quality of life is calculated by adding all responses to all 20 items. Patients rate their experience on each item a 7-point scale ranging from 1 (maximum impairment) to 7 (no impairment)
Symptom Burden (IPOS)
Time frame: From Baseline to Follow-Up (0, 8, 16, 28 weeks)
Change from baseline in palliative care needs and specific symptoms (at week 8) assessed with the Integrated Palliative Care Outcome Scale (IPOS). The IPOS includes 10 symptoms and 7 questions on patients and carers emotional situation, spiritual concerns, and provision of information and support. The overall profile score is the sum of the scores from each of the 17 questions.
Carers' burden of disease (ZBI)
Time frame: From Baseline to End of Intervention (0, 8, 16 weeks)
Change from baseline in carers' burden (at week 8) assessed with the Zarit Burden Inventory (ZBI), measuring personal strain and role strain. The revised version contains 22 items. Each item is a statement which the carer is asked to endorse using a 5-point scale. Response options range from 0 (never) to 4 (nearly always).
4 secondary outcomes
Breathlessness severity (NRS)
Time frame: From Baseline to Follow-Up (0, 8, 16, 28 weeks)
Generic health-related quality of life (EQ-5D-5L)
Time frame: From Baseline to Follow-Up (0, 8, 16, 28 weeks)
Costs of health service utilization in Euros
Time frame: From Baseline to Follow-Up (0, 8, 16, 28 weeks)
Patient survival measured in days
Time frame: From randomization until death, up to end of study (24 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Derived from this study: PubMed 33509957Schunk 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.
- Study websiteLink provided by the sponsor.
- MBS websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Bausewein, Prof.Dr.med. principal investigator
Munich University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-professional breathlessness service (MBS) and Delayed MBS Intervention in people with Breathlessness and COPD, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mastery of breathlessness (CRQ mastery subscale) (time frame: From Baseline to Follow-Up (0, 8, 16, 28 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02622412, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2019.