Clinical trial · Interventional
Cognitive and Behavioral Intervention for the Management of Episodic Breathlessness in Patients With Advanced Disease
Cognitive and Behavioral Intervention for the Management of Episodic Breathlessness in Patients With Advanced Disease: a Single-arm Therapeutic Exploratory Trial (Phase II)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breathlessness | — | UNRESOLVED | — |
| Dyspnea | — | UNRESOLVED | — |
| Heart Failure | — | UNRESOLVED | — |
| Lung Diseases | — | UNRESOLVED | — |
| Lung Diseases, Interstitial | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Palliative Care | — | UNRESOLVED | — |
| Palliative Medicine | — | UNRESOLVED | — |
| Pulmonary Disease, Chronic Obstructive | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive and Behavioral intervention for the Management of Episodic Breathlessness | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Cognitive and Behavioral Intervention
- description
- Non-pharmacological strategies for the Management of episodic breathlessness
- interventionNames
- Behavioral: Cognitive and Behavioral intervention for the Management of Episodic Breathlessness
Primary outcomes (3)
- measure
- Enrollment rate (Feasibility)
- timeFrame
- week 6
- description
- Ratio of patients screened and patients that signed informed consent
- measure
- Study completion rate (Feasibility)
- timeFrame
- week 6
- description
- Ratio of patients who signed the informed consent and filled out the final assessment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available