Cognitive and Behavioral Intervention for the Management of Episodic Breathlessness in Patients With Advanced Disease

Study Overview
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Brief Summary
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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).

Official Title
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Cognitive and Behavioral Intervention for the Management of Episodic Breathlessness in Patients With Advanced Disease: a Single-arm Therapeutic Exploratory Trial (Phase II)

Conditions
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Dyspnea, Respiratory Insufficiency, Neoplasms, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Heart Failure, Lung Diseases, Interstitial, Palliative Care, Palliative Medicine, Breathlessness

Intervention / Treatment
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* Behavioral: Cognitive and Behavioral intervention for the Management of Episodic Breathlessness


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: single-arm therapeutic exploratory trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cognitive and Behavioral Intervention<br>Non-pharmacological strategies for the Management of episodic breathlessness | Behavioral: Cognitive and Behavioral intervention for the Management of Episodic Breathlessness<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment rate (Feasibility) | Ratio of patients screened and patients that signed informed consent | week 6 | 
| Study completion rate (Feasibility) | Ratio of patients who signed the informed consent and filled out the final assessment | week 6 | 
| Drop Outs (Feasibility) | Withdrawal from the study at specific date (e.g. Intervention, refresher, Outcome at week 2/4/6) | week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of side-effects due to the brief cognitive and behavioral Intervention (Safety) | closed-ended question (yes/no) | week 6 | 
| Occurence of adverse events due to the brief cognitive and behavioral Intervention (Safety) | closed-ended Question (yes/no) | week 6 | 
| Occurence of adverse events due to the study procedure (Safety) | closed-ended Question (yes/no) | week 6 | 
| Satisfaction with the brief cognitive and behavioral intervention (Acceptability) | closed-ended Questions | week 6 | 
| Patients' experience with the Intervention and study procedure | qualitative interview | 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) | 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) | 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) | 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) | 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) | 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) | week 2, 4 and 6 | 
| Informal caregivers' burdens while caring for breathlessness patients | Zarid Burden Interview (the higher the score, the worse the Outcome) | week 2, 4 and 6 | 
| Informal caregivers' experience with Intervention and study procedure | qualitative interview | week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinical Trial, Phase II, Cognitive Behavioral Therapy, Feasibility Studies