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)

Sponsors

Lead Sponsor: University of Cologne

Collaborator: University Hospital of Cologne
Bethanien Krankenhaus gGmbH

Source 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).

Overall Status Completed
Start Date 2019-02-09
Completion Date 2020-03-15
Primary Completion Date 2020-03-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Enrollment rate (Feasibility) week 6
Study completion rate (Feasibility) week 6
Drop Outs (Feasibility) week 6
Secondary Outcome
Measure Time Frame
Occurence of side-effects due to the brief cognitive and behavioral Intervention (Safety) week 6
Occurence of adverse events due to the brief cognitive and behavioral Intervention (Safety) week 6
Occurence of adverse events due to the study procedure (Safety) week 6
Satisfaction with the brief cognitive and behavioral intervention (Acceptability) week 6
Patients' experience with the Intervention and study procedure week 6
Potential effects of the brief cognitive and behavioral Intervention on Depression week 2, 4 and 6
Potential effects of the brief cognitive and behavioral Intervention on Anxiety week 2, 4 and 6
Potential effects of the brief cognitive and behavioral Intervention on breathlessness mastery week 2, 4 and 6
Potential effects of the brief cognitive and behavioral Intervention on Quality of Life week 2, 4 and 6
Potential effects of the brief cognitive and behavioral Intervention on Palliative Care needs week 2, 4 and 6
Potential effects of the brief cognitive and behavioral Intervention on catastrophizing thoughts concerning dyspnea week 2, 4 and 6
Informal caregivers' burdens while caring for breathlessness patients week 2, 4 and 6
Informal caregivers' experience with Intervention and study procedure week 6
Enrollment 49
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Cognitive and Behavioral intervention for the Management of Episodic Breathlessness

Description: 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.

Arm Group Label: Cognitive and Behavioral Intervention

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Steffen Simon, Prof., M.Sc. Principal Investigator Center of palliative medicine
Location
Facility: University Hospital of Cologne
Location Countries

Germany

Verification Date

2020-11-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Cologne

Investigator Full Name: Prof. Dr. Steffen Simon

Investigator Title: Prfessor Dr Steffen Simon MSc

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Cognitive and Behavioral Intervention

Type: Other

Description: Non-pharmacological strategies for the Management of episodic breathlessness

Acronym CoBeMEB
Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: single-arm therapeutic exploratory trial

Primary Purpose: Other

Masking: None (Open Label)

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