A Pilot Trial of a Self-Management Intervention for Breathlessness in Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Perceived severity of breathlessness
研究概览
简要总结
The purpose of this study is to investigate the suitability and practicality of a coaching and support intervention in helping patients to use daily strategies for managing breathlessness. Also, the investigators will try to understand how useful it is in helping patients to reduce intensity of breathlessness and its impact their quality of life.
详细描述
Lung cancer is common worldwide and is a leading cause of death. Breathlessness (dyspnea or shortness of breath) is a highly prevalent clinical problem in lung cancer, developing early in 25-50% of patients due to advanced stage at presentation. It persists in 60% of survivors' post-lung resection and worsens with progressive disease with rates as high as 90% reported in the final months of life. Breathlessness is associated with a high degree of unpleasantness, negatively impacts on daily functioning, and multiple domains of quality of life, triggers fear and anxiety in patients and their family, and contributes to symptom specific and psychological distress. It is also costly to the health system as it contributes to urgent care use and hospitalization. The purpose of this pilot trial is to evaluate feasibility and acceptability of a self-management intervention for breathlessness in lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Eligible participants are women and men with lung cancer (stage I to IV) receiving chemotherapy and/or radiotherapy
- •Report breathlessness occurrence (any score >=3) on a Numerical Rating Scale (0-no breathlessness; 10 - worst breathlessness) during standardized routine distress screening and/or report breathlessness as a symptom to their health care provider
- •Normal cognitive function as measured by a score of <20 on the Short Orientation Memory Cognitive Test (SOMC)
- •ECOG performance score of 0 to 2
- •Estimated life expectancy of >3 months as per physician
- •Reside within a 45 kilometre driving radius of Princess Margaret Hospital
- •Oxygen saturation >90% at rest on room air or with oxygen
- •Available for 8 consecutive weeks of the study.
排除标准
- •Patients who have received surgery alone as the primary treatment for lung cancer
- •Unstable acute asthma or left heart failure or coronary artery or valvular heart disease or neuromuscular disease
- •Inability to comply with the study protocol including completion of the questionnaires in English
- •Major psychiatric disorder identified by the physician.
研究组 & 干预措施
Self-management Intervention
Individual, face-to-face 7-session self-management intervention delivered by a specialist oncology nurse/clinical case manager as a home-based approach using a manual for each session.
干预措施: Self-management Intervention (Behavioral)
Standard of care
Patients in this condition will receive usual care as decided by their oncology clinic team or physician.
干预措施: Self-management Intervention (Behavioral)
结局指标
主要结局
Perceived severity of breathlessness
时间窗: 8 weeks
Measured by Numeric Rating Scale for breathlessness intensity.
Affective distress of breathlessness
时间窗: 8 weeks
Measured by Distress of Breathlessness Numerical Rating Scale.
Dyspnea with activities of daily living and exercise
时间窗: 8 weeks
Measured by (a) Chronic Respiratory Questionnaire, (b) Medical Research Council Dyspnea Scale, and (c) BORG scale prior to, during, and at the end of the 6-Minute-Walk Test.
次要结局
- Self-efficacy and mastery for managing breathlessness(8 weeks)
- Beliefs about breathlessness(8 weeks)
- Adherence and Use of Self-Management Strategies(8 weeks)
- Exercise capacity(8 weeks)
- Psychological distress(8 weeks)
- Quality of life(8 weeks)
- Health care utilization(8 weeks)