Randomised Controlled Trial Testing the Effectiveness of a New Multi-professional Breathlessness sErvice for Patients With Any Advanced diSease Against Usual Care (BreathEase)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- Mastery of breathlessness (CRQ mastery subscale)
研究概览
简要总结
Breathlessness is a common and distressing symptom in patients with advanced diseases like cancer, chronic obstructive pulmonary disease (COPD), chronic heart failure (CHF) or lung fibrosis, which broadly impacts on patients' quality of life and may result in high burden for carers.
This single-blinded randomized controlled fast track trial evaluates the effectiveness of a multi-professional breathlessness service in patients with advanced and chronic diseases. The intervention group will get immediate access to the breathlessness service whereas the control group will receive standard care and get access to the service after a waiting time of eight weeks. Primary endpoints are mastery of breathlessness and quality of life, measured with the CRQ (Chronic Respiratory Questionnaire) as well as the reduction of symptom burden of patients and burden of carers. The evaluation of the cost effectiveness of the breathlessness service from the perspective of the German health system is a further study aim.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Patients affected by breathlessness due to any advanced life-limiting and progressive disease, despite treatment of the underlying condition and
- •Patients capable (in a cognitive and functional manner) to participate in the intervention including outpatient clinic and physiotherapist visits as well as self- management
- •If patients are suffering from acute exacerbations of the underlying conditions, they are put on a waiting list for two to four weeks and are then entered into the trial.
排除标准
- •Patients suffering from breathlessness due to chronic hyperventilation syndrome, asthma or any other unknown cause
- •Cancer patients under concurrent initial or full dose systemic treatment or radiotherapy (except on maintenance therapy)
- •Patients participating in any trial targeting the treatment of underlying conditions/ illness
研究组 & 干预措施
Intervention Group
Patients randomised to the intervention group will get immediate access to the Multi-professional breathlessness service (MBS).
干预措施: Multi-professional breathlessness service (MBS) (Other)
Control Group
Patients randomised to the control group will get delayed MBS intervention. They will receive standard care and get access to the service after a waiting time of eight weeks.
干预措施: Delayed MBS Intervention (Other)
结局指标
主要结局
Mastery of breathlessness (CRQ mastery subscale)
时间窗: From Baseline to Follow-Up (0, 8, 16, 28 weeks)
Change from baseline in Mastery of breathlessness (at week 8) measured with the Chronic Respiratory Disease Questionnaire (CRQ) in a face-to-face interview. Mastery represents one of the four CRQ domains containing 4 items. Patients rate their experience on each item a 7-point scale ranging from 1 (maximum impairment) to 7 (no impairment). The subscale "Mastery" is calculated by averaging the scores of the 4 items belonging to this subscale.
Quality of Life (CRQ)
时间窗: From Baseline to Follow-Up (0, 8, 16, 28 weeks)
Change from baseline in Quality of Life (at week 8) measured with the CRQ. The CRQ contains 20 items across four domains: dyspnea, fatigue, emotional function, and mastery. Quality of life is calculated by adding all responses to all 20 items. Patients rate their experience on each item a 7-point scale ranging from 1 (maximum impairment) to 7 (no impairment)
Symptom Burden (IPOS)
时间窗: From Baseline to Follow-Up (0, 8, 16, 28 weeks)
Change from baseline in palliative care needs and specific symptoms (at week 8) assessed with the Integrated Palliative Care Outcome Scale (IPOS). The IPOS includes 10 symptoms and 7 questions on patients and carers emotional situation, spiritual concerns, and provision of information and support. The overall profile score is the sum of the scores from each of the 17 questions.
Carers' burden of disease (ZBI)
时间窗: From Baseline to End of Intervention (0, 8, 16 weeks)
Change from baseline in carers' burden (at week 8) assessed with the Zarit Burden Inventory (ZBI), measuring personal strain and role strain. The revised version contains 22 items. Each item is a statement which the carer is asked to endorse using a 5-point scale. Response options range from 0 (never) to 4 (nearly always).
次要结局
- Breathlessness severity (NRS)(From Baseline to Follow-Up (0, 8, 16, 28 weeks))
- Costs of health service utilization in Euros(From Baseline to Follow-Up (0, 8, 16, 28 weeks))
- Patient survival measured in days(From randomization until death, up to end of study (24 months))
- Generic health-related quality of life (EQ-5D-5L)(From Baseline to Follow-Up (0, 8, 16, 28 weeks))
研究者
Claudia Bausewein
Prof. Dr. med.
Ludwig-Maximilians - University of Munich