Cognitive and Behavioral Intervention for the Management of Episodic Breathlessness in Patients With Advanced Disease
- Conditions
- Respiratory InsufficiencyHeart FailureLung Diseases, InterstitialPalliative MedicineDyspneaPulmonary Disease, Chronic ObstructiveLung DiseasesPalliative CareBreathlessnessNeoplasms
- Interventions
- Behavioral: Cognitive and Behavioral intervention for the Management of Episodic Breathlessness
- Registration Number
- NCT04630743
- Lead Sponsor
- University of Cologne
- Brief 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. 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cognitive and Behavioral Intervention Cognitive and Behavioral intervention for the Management of Episodic Breathlessness Non-pharmacological strategies for the Management of episodic breathlessness
- Primary Outcome Measures
Name Time Method Enrollment rate (Feasibility) week 6 Ratio of patients screened and patients that signed informed consent
Study completion rate (Feasibility) week 6 Ratio of patients who signed the informed consent and filled out the final assessment
Drop Outs (Feasibility) week 6 Withdrawal from the study at specific date (e.g. Intervention, refresher, Outcome at week 2/4/6)
- Secondary Outcome Measures
Name Time Method Satisfaction with the brief cognitive and behavioral intervention (Acceptability) week 6 closed-ended Questions
Patients' experience with the Intervention and study procedure week 6 qualitative interview
Potential effects of the brief cognitive and behavioral Intervention on breathlessness mastery week 2, 4 and 6 Mastery Domain of the Chronic Respiratory Questionnaire (the higher the score, the better the outcome)
Occurence of side-effects due to the brief cognitive and behavioral Intervention (Safety) week 6 closed-ended question (yes/no)
Occurence of adverse events due to the study procedure (Safety) week 6 closed-ended Question (yes/no)
Potential effects of the brief cognitive and behavioral Intervention on Depression week 2, 4 and 6 Hospital Anxiety and Depression Scale: the Depression Subscale (the higher the score, the worse the outcome)
Potential effects of the brief cognitive and behavioral Intervention on Anxiety week 2, 4 and 6 Hospital Anxiety and Depression Scale: the Anxiety Subscale (the higher the score, the worse the outcome)
Occurence of adverse events due to the brief cognitive and behavioral Intervention (Safety) week 6 closed-ended Question (yes/no)
Potential effects of the brief cognitive and behavioral Intervention on Palliative Care needs week 2, 4 and 6 Integrated Palliative Care Outcome Scale (the higher the score, the worse the outcome)
Potential effects of the brief cognitive and behavioral Intervention on Quality of Life week 2, 4 and 6 Chronic Respiratory Questionnaire (the higher the score, the better the outcome)
Informal caregivers' burdens while caring for breathlessness patients week 2, 4 and 6 Zarid Burden Interview (the higher the score, the worse the Outcome)
Potential effects of the brief cognitive and behavioral Intervention on catastrophizing thoughts concerning dyspnea week 2, 4 and 6 Dyspnea catastrophizing scale (the higher the score, the worse the outcome)
Informal caregivers' experience with Intervention and study procedure week 6 qualitative interview
Trial Locations
- Locations (1)
University Hospital of Cologne
🇩🇪Cologne, NRW, Germany