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

November 13, 2020 updated by: Prof. Dr. Steffen Simon, University of Cologne

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Cologne, NRW, Germany, 50937
        • University Hospital of Cologne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Cognitive and Behavioral Intervention
Non-pharmacological strategies for the Management of episodic breathlessness
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enrollment rate (Feasibility)
Time Frame: week 6
Ratio of patients screened and patients that signed informed consent
week 6
Study completion rate (Feasibility)
Time Frame: week 6
Ratio of patients who signed the informed consent and filled out the final assessment
week 6
Drop Outs (Feasibility)
Time Frame: week 6
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)
Time Frame: week 6
closed-ended question (yes/no)
week 6
Occurence of adverse events due to the brief cognitive and behavioral Intervention (Safety)
Time Frame: week 6
closed-ended Question (yes/no)
week 6
Occurence of adverse events due to the study procedure (Safety)
Time Frame: week 6
closed-ended Question (yes/no)
week 6
Satisfaction with the brief cognitive and behavioral intervention (Acceptability)
Time Frame: week 6
closed-ended Questions
week 6
Patients' experience with the Intervention and study procedure
Time Frame: week 6
qualitative interview
week 6
Potential effects of the brief cognitive and behavioral Intervention on Depression
Time Frame: week 2, 4 and 6
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
Time Frame: week 2, 4 and 6
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
Time Frame: week 2, 4 and 6
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
Time Frame: week 2, 4 and 6
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
Time Frame: week 2, 4 and 6
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
Time Frame: week 2, 4 and 6
Dyspnea catastrophizing scale (the higher the score, the worse the outcome)
week 2, 4 and 6
Informal caregivers' burdens while caring for breathlessness patients
Time Frame: week 2, 4 and 6
Zarid Burden Interview (the higher the score, the worse the Outcome)
week 2, 4 and 6
Informal caregivers' experience with Intervention and study procedure
Time Frame: week 6
qualitative interview
week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Collaborators

University Hospital of Cologne
Bethanien Krankenhaus gGmbH

Investigators

  • Principal Investigator: Steffen Simon, Prof., M.Sc., Center of palliative medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 9, 2019

Primary Completion (ACTUAL)

March 1, 2020

Study Completion (ACTUAL)

March 15, 2020

Study Registration Dates

First Submitted

November 6, 2020

First Submitted That Met QC Criteria

November 13, 2020

First Posted (ACTUAL)

November 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 16, 2020

Last Update Submitted That Met QC Criteria

November 13, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uni-Koeln-0917

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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