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

NCT04630743 | Completed

• 1 other identifier: Uni-Koeln-0917
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Enrollment rate (Feasibility)

  Ratio of patients screened and patients that signed informed consent

  week 6

• Study completion rate (Feasibility)

  Ratio of patients who signed the informed consent and filled out the final assessment

  week 6

• Drop Outs (Feasibility)

  Withdrawal from the study at specific date (e.g. Intervention, refresher, Outcome at week 2/4/6)

  week 6

Secondary Outcomes (13)

• 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

Study Arms (1)

Cognitive and Behavioral Intervention

OTHER

Non-pharmacological strategies for the Management of episodic breathlessness

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

Interventions

Cognitive and Behavioral intervention for the Management of Episodic Breathlessness 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.

Cognitive and Behavioral Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cologne: lead
• University Hospital of Cologne: collaborator
• Bethanien Krankenhaus gGmbH: collaborator

Study Sites (1)

University Hospital of Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

Location

MeSH Terms

Conditions

Dyspnea; Respiratory Insufficiency; Neoplasms; Pulmonary Disease, Chronic Obstructive; Lung Diseases; Heart Failure; Lung Diseases, Interstitial

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Steffen Simon, Prof., M.Sc.

  Center of palliative medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prfessor Dr Steffen Simon MSc

Model Details: single-arm therapeutic exploratory trial

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 16, 2020
• Study Start: February 9, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 15, 2020
• Last Updated: November 16, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)