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临床试验/NCT01585883
NCT01585883已完成不适用

A Pilot Trial of a Self-Management Intervention for Breathlessness in Lung Cancer

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2011年11月30日最近更新:
适应症
干预措施

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Self-management Intervention

Experimental

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

Active Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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