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Completed

NCT Number: NCT04630743

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

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).

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Key information

Conditions

Dyspnea Breathlessness Cardiovascular Diseases Chronic Disease Disease Attributes Heart Diseases Heart Failure Lung Diseases Lung Diseases, Interstitial Lung Diseases, Obstructive Neoplasms Palliative Care Palliative Medicine Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Enrollment rate (Feasibility)

    Time frame: week 6

    Ratio of patients screened and patients that signed informed consent

  2. Study completion rate (Feasibility)

    Time frame: week 6

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

  3. Drop Outs (Feasibility)

    Time frame: week 6

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

Secondary outcomes

  1. Occurence of side-effects due to the brief cognitive and behavioral Intervention (Safety)

    Time frame: week 6

    closed-ended question (yes/no)

  2. Occurence of adverse events due to the brief cognitive and behavioral Intervention (Safety)

    Time frame: week 6

    closed-ended Question (yes/no)

  3. Occurence of adverse events due to the study procedure (Safety)

    Time frame: week 6

    closed-ended Question (yes/no)

  4. Satisfaction with the brief cognitive and behavioral intervention (Acceptability)

    Time frame: week 6

    closed-ended Questions

  5. Patients' experience with the Intervention and study procedure

    Time frame: week 6

    qualitative interview

  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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. Informal caregivers' experience with Intervention and study procedure

    Time frame: week 6

    qualitative interview

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Collaborators

  • Bethanien Krankenhaus gGmbH
  • University Hospital of Cologne

Registry information

Official study title

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

Acronym: CoBeMEB

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 16, 2020
Registry last updated
Nov 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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