DyspneaCoBeMEBNCT04630743
Cognitive and Behavioral Intervention for the Management of Episodic Breathlessness in Patients With Advanced Disease
A study testing Cognitive and Behavioral intervention for the Management of Episodic Breathlessness in people with Dyspnea and Respiratory Insufficiency, run by University of Cologne at 1 site in Germany.
Trial summary
Episodic breathlessness is a common and distressing symptom in patients with advanced disease such as cancer, chronic obstructive pulmonary disease (COPD) and chronic heart failure. Since the short duration of the majority of breathless episodes limits the effectiveness of pharmacological interventions (e.g. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea, Respiratory Insufficiency, Neoplasms
- What is being tested?
- Cognitive and Behavioral intervention for the Management of Episodic Breathlessness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteGermany
- Study dates
- 9 Feb 2019to 15 Mar 2020
- 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
- In- and outpatients of the participating centers with episodic breathlessness due to a life-limiting progressive disease
- Recurrent breathlessness episodes despite optimal treatment of the underlying disease
- Eastern Cooperative Oncology Group (ECOG) status 0-3
- Estimated life-expectancy should be at least 8 weeks as judged by the treating physician
- Ability to understand, read, and respond to German language
- Informed consent
Who cannot join
- Episodic breathlessness due to reversible and treatable causes, such as acute pneumonia, pulmonary embolism, chronic hyperventilation syndrome, asthma or other reversible or unknown cause
- Cognitive impairment
- Severe current health impairments that do not allow participation after clinical evaluation by the treating physician
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Cologne
Cologne, North Rhine-Westphalia, 50937
About this study
Official title: Cognitive and Behavioral Intervention for the Management of Episodic Breathlessness in Patients With Advanced Disease: a Single-arm Therapeutic Exploratory Trial (Phase II)
Episodic breathlessness is a common and distressing symptom in patients with advanced disease such as cancer, chronic obstructive pulmonary disease (COPD) and chronic heart failure. Since the short duration of the majority of breathless episodes limits the effectiveness of pharmacological interventions (e.g. opioids), non-pharmacological management strategies play a major role. As non-pharmacological strategies patients use, for example, cognitive and behavioural methods such as breathing or relaxation techniques.
The aim of the study is to test a brief cognitive and behavioural intervention for an improved management of episodic breathlessness. Initially, a Delphi procedure with international experts has been used to develop the brief intervention consisting of various non-pharmacological strategies to enhance the management of breathless episodes.
In the single-arm therapeutic exploratory trial (phase II), the feasibility and potential effects of the brief intervention, such as patient-reported breathlessness mastery, episodic breathlessness characteristics, quality of life, symptom burden, caregivers' burden, and breathlessness in general will be examined. The results of the study form the basis for planning and implementing a subsequent confirmatory randomized control trial (phase III).
- Conditions
- Dyspnea, Respiratory Insufficiency, Neoplasms, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Heart Failure
- Being tested
- Cognitive and Behavioral intervention for the Management of Episodic Breathlessness
- Keywords
- Clinical Trial, Phase II, Cognitive Behavioral Therapy, Feasibility Studies
- Medical subject headings
- Dyspnea, Respiratory Insufficiency, Neoplasms, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Heart Failure, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive and Behavioral intervention for the Management of Episodic BreathlessnessBehavioural
The cognitive and behavioral brief intervention comprises two parts: In a first module, the intervention and the study team is introduced, the definition of episodic breathlessness is given and the individual characteristics of breathlessness episodes are recorded. Goals of the intervention are discussed. In a subsequent module on patient education and the strategies, the patient and intervention executor discuss the patients' assumptions about episodic breathlessness including triggers and already used management strategies for breathlessness episodes. This follows the presentation of the non-pharmacological strategies: movement of air/ handheld fan, forward lean, diaphragmatic breathing, distraction, pursed lips breathing, long breaths out and relaxation training. The patient selects 2-3 strategies and trains them with the intervention executor.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive and Behavioral Intervention | Other | Non-pharmacological strategies for the Management of episodic breathlessness Receives: Behavioral: Cognitive and Behavioral intervention for the Management of Episodic Breathlessness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate (Feasibility)
Ratio of patients screened and patients that signed informed consent
Measured: week 6
Study completion rate (Feasibility)
Ratio of patients who signed the informed consent and filled out the final assessment
Measured: week 6
Drop Outs (Feasibility)
Withdrawal from the study at specific date (e.g. Intervention, refresher, Outcome at week 2/4/6)
Measured: week 6
Secondary outcomes (13)
Occurence of side-effects due to the brief cognitive and behavioral Intervention (Safety)
closed-ended question (yes/no)
Measured: week 6
Occurence of adverse events due to the brief cognitive and behavioral Intervention (Safety)
closed-ended Question (yes/no)
Measured: week 6
Occurence of adverse events due to the study procedure (Safety)
closed-ended Question (yes/no)
Measured: week 6
Satisfaction with the brief cognitive and behavioral intervention (Acceptability)
closed-ended Questions
Measured: week 6
Patients' experience with the Intervention and study procedure
qualitative interview
Measured: week 6
Potential effects of the brief cognitive and behavioral Intervention on Depression
Hospital Anxiety and Depression Scale: the Depression Subscale (the higher the score, the worse the outcome)
Measured: week 2, 4 and 6
Potential effects of the brief cognitive and behavioral Intervention on Anxiety
Hospital Anxiety and Depression Scale: the Anxiety Subscale (the higher the score, the worse the outcome)
Measured: week 2, 4 and 6
Potential effects of the brief cognitive and behavioral Intervention on breathlessness mastery
Mastery Domain of the Chronic Respiratory Questionnaire (the higher the score, the better the outcome)
Measured: week 2, 4 and 6
Potential effects of the brief cognitive and behavioral Intervention on Quality of Life
Chronic Respiratory Questionnaire (the higher the score, the better the outcome)
Measured: week 2, 4 and 6
Potential effects of the brief cognitive and behavioral Intervention on Palliative Care needs
Integrated Palliative Care Outcome Scale (the higher the score, the worse the outcome)
Measured: week 2, 4 and 6
Potential effects of the brief cognitive and behavioral Intervention on catastrophizing thoughts concerning dyspnea
Dyspnea catastrophizing scale (the higher the score, the worse the outcome)
Measured: week 2, 4 and 6
Informal caregivers' burdens while caring for breathlessness patients
Zarid Burden Interview (the higher the score, the worse the Outcome)
Measured: week 2, 4 and 6
Informal caregivers' experience with Intervention and study procedure
qualitative interview
Measured: week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start9 Feb 2019
- Primary completion1 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single-arm therapeutic exploratory trial
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Cologne, Bethanien Krankenhaus gGmbH
- Responsible party
- Principal investigator, Prof. Dr. Steffen Simon, University of Cologne
- Investigators
- Steffen Simon, Prof., M.Sc., Principal investigator, Center of palliative medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630743
- Sponsor's protocol ID
- Uni-Koeln-0917
- Acronym
- CoBeMEB
- Status last verified
- Nov 2020
- First submitted
- 6 Nov 2020
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Behavioral Intervention for the Management of Episodic Breathlessness in Patients With Advanced Disease: a Single-arm Therapeutic Exploratory Trial (Phase II)
- ClinicalTrials.gov ID
- NCT04630743
- Acronym / sponsor ID
- CoBeMEB / Uni-Koeln-0917
- Conditions
- Dyspnea, Respiratory Insufficiency, Neoplasms, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Heart Failure
- Keywords
- Clinical Trial, Phase II, Cognitive Behavioral Therapy, Feasibility Studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- University Hospital of Cologne, Bethanien Krankenhaus gGmbH
- Study start
- 9 Feb 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 16 Nov 2020 (actual)
- 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.
Episodic breathlessness is a common and distressing symptom in patients with advanced disease such as cancer, chronic obstructive pulmonary disease (COPD) and chronic heart failure. Since the short duration of the majority of breathless episodes limits the effectiveness of pharmacological interventions (e.g. opioids), non-pharmacological management strategies play a major role. As non-pharmacological strategies patients use, for example, cognitive and behavioural methods such as breathing or relaxation techniques.
The aim of the study is to test a brief cognitive and behavioural intervention for an improved management of episodic breathlessness. Initially, a Delphi procedure with international experts has been used to develop the brief intervention consisting of various non-pharmacological strategies to enhance the management of breathless episodes.
In the single-arm therapeutic exploratory trial (phase II), the feasibility and potential effects of the brief intervention, such as patient-reported breathlessness mastery, episodic breathlessness characteristics, quality of life, symptom burden, caregivers' burden, and breathlessness in general will be examined. The results of the study form the basis for planning and implementing a subsequent confirmatory randomized control trial (phase III).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-arm therapeutic exploratory trial
| Arm | Type | Receives |
|---|---|---|
| Cognitive and Behavioral Intervention | Other | Behavioral: Cognitive and Behavioral intervention for the Management of Episodic BreathlessnessNon-pharmacological strategies for the Management of episodic breathlessness |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- In- and outpatients of the participating centers with episodic breathlessness due to a life-limiting progressive disease
- Recurrent breathlessness episodes despite optimal treatment of the underlying disease
- Eastern Cooperative Oncology Group (ECOG) status 0-3
- Estimated life-expectancy should be at least 8 weeks as judged by the treating physician
- Ability to understand, read, and respond to German language
Key exclusion criteria (3 listed)
- Episodic breathlessness due to reversible and treatable causes, such as acute pneumonia, pulmonary embolism, chronic hyperventilation syndrome, asthma or other reversible or unknown cause
- Cognitive impairment
- Severe current health impairments that do not allow participation after clinical evaluation by the treating physician
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 |
|---|---|---|
| Cognitive and Behavioral intervention for the Management of Episodic BreathlessnessThe cognitive and behavioral brief intervention comprises two parts: In a first module, the intervention and the study team is introduced, the definition of episodic breathlessness is given and the individual characteristics of breathlessness episodes are recorded. Goals of the intervention are discussed. In a subsequent module on patient education and the strategies, the patient and intervention executor discuss the patients' assumptions about episodic breathlessness including triggers and already used management strategies for breathlessness episodes. This follows the presentation of the non-pharmacological strategies: movement of air/ handheld fan, forward lean, diaphragmatic breathing, distraction, pursed lips breathing, long breaths out and relaxation training. The patient selects 2-3 strategies and trains them with the intervention executor. | Behavioural | Cognitive and Behavioral Intervention |
Primary outcome
Enrollment rate (Feasibility)
Time frame: week 6
Ratio of patients screened and patients that signed informed consent
Study completion rate (Feasibility)
Time frame: week 6
Ratio of patients who signed the informed consent and filled out the final assessment
Drop Outs (Feasibility)
Time frame: week 6
Withdrawal from the study at specific date (e.g. Intervention, refresher, Outcome at week 2/4/6)
13 secondary outcomes
Occurence of side-effects due to the brief cognitive and behavioral Intervention (Safety)
Time frame: week 6
Occurence of adverse events due to the brief cognitive and behavioral Intervention (Safety)
Time frame: week 6
Occurence of adverse events due to the study procedure (Safety)
Time frame: week 6
Satisfaction with the brief cognitive and behavioral intervention (Acceptability)
Time frame: week 6
Patients' experience with the Intervention and study procedure
Time frame: week 6
Potential effects of the brief cognitive and behavioral Intervention on Depression
Time frame: week 2, 4 and 6
Potential effects of the brief cognitive and behavioral Intervention on Anxiety
Time frame: week 2, 4 and 6
Potential effects of the brief cognitive and behavioral Intervention on breathlessness mastery
Time frame: week 2, 4 and 6
Potential effects of the brief cognitive and behavioral Intervention on Quality of Life
Time frame: week 2, 4 and 6
Potential effects of the brief cognitive and behavioral Intervention on Palliative Care needs
Time frame: week 2, 4 and 6
Potential effects of the brief cognitive and behavioral Intervention on catastrophizing thoughts concerning dyspnea
Time frame: week 2, 4 and 6
Informal caregivers' burdens while caring for breathlessness patients
Time frame: week 2, 4 and 6
Informal caregivers' experience with Intervention and study procedure
Time frame: week 6
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 16 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Steffen Simon, Prof., M.Sc. principal investigator
Center of palliative medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive and Behavioral intervention for the Management of Episodic Breathlessness in people with Dyspnea and Respiratory Insufficiency, run by University of Cologne 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 6 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 16 Nov 2020. 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?
Enrollment rate (Feasibility) (time frame: week 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Nov 2020.