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

Heart Failure Clinical Trial

— CoBeMEB  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04630743
• Other study ID #: Uni-Koeln-0917
• Status: Completed
• Phase: N/A
• Start date: February 9, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: November 2020
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 15, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Cognitive and Behavioral intervention for the Management of Episodic Breathlessness
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.

Locations

Country	Name	City	State
Germany	University Hospital of Cologne	Cologne	NRW

Sponsors (3)

Lead Sponsor	Collaborator
University of Cologne	Bethanien Krankenhaus gGmbH, University Hospital of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment rate (Feasibility)	Ratio of patients screened and patients that signed informed consent	week 6
Primary	Study completion rate (Feasibility)	Ratio of patients who signed the informed consent and filled out the final assessment	week 6
Primary	Drop Outs (Feasibility)	Withdrawal from the study at specific date (e.g. Intervention, refresher, Outcome at week 2/4/6)	week 6
Secondary	Occurence of side-effects due to the brief cognitive and behavioral Intervention (Safety)	closed-ended question (yes/no)	week 6
Secondary	Occurence of adverse events due to the brief cognitive and behavioral Intervention (Safety)	closed-ended Question (yes/no)	week 6
Secondary	Occurence of adverse events due to the study procedure (Safety)	closed-ended Question (yes/no)	week 6
Secondary	Satisfaction with the brief cognitive and behavioral intervention (Acceptability)	closed-ended Questions	week 6
Secondary	Patients' experience with the Intervention and study procedure	qualitative interview	week 6
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Informal caregivers' burdens while caring for breathlessness patients	Zarid Burden Interview (the higher the score, the worse the Outcome)	week 2, 4 and 6
Secondary	Informal caregivers' experience with Intervention and study procedure	qualitative interview	week 6