Cognitive and Behavioral Intervention for the Management of Episodic Breathlessness in Patients With Advanced Disease: a Single-arm Therapeutic Exploratory Trial (Phase II)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Enrollment rate (Feasibility)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Enrollment rate (Feasibility)
时间窗: week 6
Ratio of patients screened and patients that signed informed consent
Study completion rate (Feasibility)
时间窗: week 6
Ratio of patients who signed the informed consent and filled out the final assessment
Drop Outs (Feasibility)
时间窗: week 6
Withdrawal from the study at specific date (e.g. Intervention, refresher, Outcome at week 2/4/6)
次要结局
- Satisfaction with the brief cognitive and behavioral intervention (Acceptability)(week 6)
- Patients' experience with the Intervention and study procedure(week 6)
- Potential effects of the brief cognitive and behavioral Intervention on breathlessness mastery(week 2, 4 and 6)
- Occurence of adverse events due to the study procedure (Safety)(week 6)
- Potential effects of the brief cognitive and behavioral Intervention on Depression(week 2, 4 and 6)
- Potential effects of the brief cognitive and behavioral Intervention on Anxiety(week 2, 4 and 6)
- 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)
- Potential effects of the brief cognitive and behavioral Intervention on Palliative Care needs(week 2, 4 and 6)
- Potential effects of the brief cognitive and behavioral Intervention on Quality of Life(week 2, 4 and 6)
- Informal caregivers' burdens while caring for breathlessness patients(week 2, 4 and 6)
- Potential effects of the brief cognitive and behavioral Intervention on catastrophizing thoughts concerning dyspnea(week 2, 4 and 6)
- Informal caregivers' experience with Intervention and study procedure(week 6)
研究者
Prof. Dr. Steffen Simon
Prfessor Dr Steffen Simon MSc
University of Cologne