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

NCT ID: NCT04630743

Last Updated: 2020-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-09
• Study Completion Date: 2020-03-15

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).

Conditions

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

Keywords

Clinical Trial; Phase II; Cognitive Behavioral Therapy; Feasibility Studies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Cognitive and Behavioral Intervention

Non-pharmacological strategies for the Management of episodic breathlessness

Group Type: OTHER

Cognitive and Behavioral intervention for the Management of Episodic Breathlessness

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Cologne

OTHER

Sponsor Role: collaborator

Bethanien Krankenhaus gGmbH

OTHER

Sponsor Role: collaborator

University of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Steffen Simon

Prfessor Dr Steffen Simon MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steffen Simon, Prof., M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Center of palliative medicine

Locations

University Hospital of Cologne

Cologne, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

Uni-Koeln-0917

Identifier Type: -

Identifier Source: org_study_id