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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
49
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.
University Hospital of Cologne
Cologne, North Rhine-Westphalia, Germany
Enrollment rate (Feasibility)
Ratio of patients screened and patients that signed informed consent
Time frame: week 6
Study completion rate (Feasibility)
Ratio of patients who signed the informed consent and filled out the final assessment
Time frame: week 6
Drop Outs (Feasibility)
Withdrawal from the study at specific date (e.g. Intervention, refresher, Outcome at week 2/4/6)
Time frame: week 6
Occurence of side-effects due to the brief cognitive and behavioral Intervention (Safety)
closed-ended question (yes/no)
Time frame: week 6
Occurence of adverse events due to the brief cognitive and behavioral Intervention (Safety)
closed-ended Question (yes/no)
Time frame: week 6
Occurence of adverse events due to the study procedure (Safety)
closed-ended Question (yes/no)
Time frame: week 6
Satisfaction with the brief cognitive and behavioral intervention (Acceptability)
closed-ended Questions
Time frame: week 6
Patients' experience with the Intervention and study procedure
qualitative interview
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: week 2, 4 and 6
Informal caregivers' burdens while caring for breathlessness patients
Zarid Burden Interview (the higher the score, the worse the Outcome)
Time frame: week 2, 4 and 6
Informal caregivers' experience with Intervention and study procedure
qualitative interview
Time frame: week 6
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