Clinical trial NCT04630743: Cognitive and Behavioral Intervention for the Management of Episodic Breathlessness in Patients With Advanced Disease
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Cologne
Sponsor class: OTHER
Collaborators: name: University Hospital of Cologne
name: Bethanien Krankenhaus gGmbH
First posted: 2020-11-16
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single-arm therapeutic exploratory trial
Primary purpose: OTHER

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).


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

Primary outcomes:
measure: Enrollment rate (Feasibility)
timeFrame: week 6
measure: Study completion rate (Feasibility)
timeFrame: week 6
measure: Drop Outs (Feasibility)
timeFrame: week 6
Secondary outcomes:
measure: Occurence of side-effects due to the brief cognitive and behavioral Intervention (Safety)
timeFrame: week 6
measure: Occurence of adverse events due to the brief cognitive and behavioral Intervention (Safety)
timeFrame: week 6
measure: Occurence of adverse events due to the study procedure (Safety)
timeFrame: week 6
measure: Satisfaction with the brief cognitive and behavioral intervention (Acceptability)
timeFrame: week 6
measure: Patients' experience with the Intervention and study procedure
timeFrame: week 6
measure: Potential effects of the brief cognitive and behavioral Intervention on Depression
timeFrame: week 2, 4 and 6
measure: Potential effects of the brief cognitive and behavioral Intervention on Anxiety
timeFrame: week 2, 4 and 6
measure: Potential effects of the brief cognitive and behavioral Intervention on breathlessness mastery
timeFrame: week 2, 4 and 6
measure: Potential effects of the brief cognitive and behavioral Intervention on Quality of Life
timeFrame: week 2, 4 and 6
measure: Potential effects of the brief cognitive and behavioral Intervention on Palliative Care needs
timeFrame: week 2, 4 and 6
measure: Potential effects of the brief cognitive and behavioral Intervention on catastrophizing thoughts concerning dyspnea
timeFrame: week 2, 4 and 6
measure: Informal caregivers' burdens while caring for breathlessness patients
timeFrame: week 2, 4 and 6
measure: Informal caregivers' experience with Intervention and study procedure
timeFrame: week 6
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital of Cologne
state: NRW
Study officials:
affiliation: Center of palliative medicine
name: Steffen Simon, Prof., M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: