Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04630743
Other study ID # Uni-Koeln-0917
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 9, 2019
Est. completion date March 15, 2020

Study information

Verified date November 2020
Source University of Cologne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date March 15, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Germany University Hospital of Cologne Cologne NRW

Sponsors (3)

Lead Sponsor Collaborator
University of Cologne Bethanien Krankenhaus gGmbH, University Hospital of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Enrollment rate (Feasibility) Ratio of patients screened and patients that signed informed consent week 6
Primary Study completion rate (Feasibility) Ratio of patients who signed the informed consent and filled out the final assessment week 6
Primary Drop Outs (Feasibility) Withdrawal from the study at specific date (e.g. Intervention, refresher, Outcome at week 2/4/6) week 6
Secondary Occurence of side-effects due to the brief cognitive and behavioral Intervention (Safety) closed-ended question (yes/no) week 6
Secondary Occurence of adverse events due to the brief cognitive and behavioral Intervention (Safety) closed-ended Question (yes/no) week 6
Secondary Occurence of adverse events due to the study procedure (Safety) closed-ended Question (yes/no) week 6
Secondary Satisfaction with the brief cognitive and behavioral intervention (Acceptability) closed-ended Questions week 6
Secondary Patients' experience with the Intervention and study procedure qualitative interview week 6
Secondary Potential effects of the brief cognitive and behavioral Intervention on Depression Hospital Anxiety and Depression Scale: the Depression Subscale (the higher the score, the worse the outcome) week 2, 4 and 6
Secondary Potential effects of the brief cognitive and behavioral Intervention on Anxiety Hospital Anxiety and Depression Scale: the Anxiety Subscale (the higher the score, the worse the outcome) week 2, 4 and 6
Secondary Potential effects of the brief cognitive and behavioral Intervention on breathlessness mastery Mastery Domain of the Chronic Respiratory Questionnaire (the higher the score, the better the outcome) week 2, 4 and 6
Secondary Potential effects of the brief cognitive and behavioral Intervention on Quality of Life Chronic Respiratory Questionnaire (the higher the score, the better the outcome) week 2, 4 and 6
Secondary Potential effects of the brief cognitive and behavioral Intervention on Palliative Care needs Integrated Palliative Care Outcome Scale (the higher the score, the worse the outcome) week 2, 4 and 6
Secondary Potential effects of the brief cognitive and behavioral Intervention on catastrophizing thoughts concerning dyspnea Dyspnea catastrophizing scale (the higher the score, the worse the outcome) week 2, 4 and 6
Secondary Informal caregivers' burdens while caring for breathlessness patients Zarid Burden Interview (the higher the score, the worse the Outcome) week 2, 4 and 6
Secondary Informal caregivers' experience with Intervention and study procedure qualitative interview week 6
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Active, not recruiting NCT05896904 - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction N/A
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Recruiting NCT05631275 - The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
Enrolling by invitation NCT05564572 - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Recruiting NCT04177199 - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Recruiting NCT06340048 - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure Phase 1/Phase 2
Recruiting NCT05679713 - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed NCT04254328 - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure N/A
Completed NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05538611 - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Completed NCT06026683 - Conduction System Stimulation to Avoid Left Ventricle Dysfunction N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT05564689 - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy