A Pilot Study to Test a Cognitive-Behavioral Model for Dyspnea in Patients With Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Change in shortness of breath
研究概览
简要总结
This trial studies the effect of a form of cognitive-behavioral therapy, Take a Breath, on reducing the intensity and frequency of dyspnea (difficulty breathing) in patients with lung cancer. Take a Breath consists of individual therapy sessions that educate patients on dyspnea and provides coping strategies.
详细描述
PRIMARY OBJECTIVE:
I. To determine the acceptability (based on patient satisfaction), tolerability (based on rate of symptom exacerbation from pre- to post-treatment), and feasibility (based on number of patients agreeing to be participate, adherence rate, and retention rate of treatment) of Take a Breath (TAB), a skills-based cognitive-behavioral treatment lasting 4 weekly hour-long sessions targeting dyspnea and related distress and impairment, in adults with lung cancer (N=40).
SECONDARY OBJECTIVES:
I. To provide preliminary data on the effectiveness of TAB on dyspnea and related distress and impairment.
II. To test cognitive-behavioral variables (physical symptoms, thoughts, behaviors, and emotions) as predictors of dyspnea severity and anxiety sensitivity as a moderator.
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
- •Diagnosed with non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC)
- •Currently experiencing dyspnea as defined by a score >= 1 on the American Thoracic Society (ATS) Dyspnea Questionnaire within 3 weeks of enrollment
- •Seeking medical oncology care and treatment at the Ohio State University Comprehensive Cancer Center (OSUCCC) Thoracic Oncology Clinic
- •Ability to understand and willingness to sign an informed consent document
排除标准
- •Presence of other serious comorbidities that would interfere with patients' study participation (e.g., serious mental illness, heart disease) as determined by the treating oncologist
- •Life expectancy < 2 months
- •History of surgery for lung cancer
结局指标
主要结局
Change in shortness of breath
时间窗: Baseline up to 1 month post-treatment
Will be assessed per the Shortness of Breath Questionnaire. The BCS is a 13-item self-report measure of catastrophic thoughts regarding breathlessness\[59\]. Patients rate "the degree to which you have these thoughts and feelings when you are experiencing breathlessness" (e.g., "I feel I can't go on"). Each item is rated on a 5-point Likert scale (0=not at all to 4=all the time). The BCS is a reliable measure and was originally validated in patients with severe COPD.
Change in dyspnea severity using the American Thoracic Society Dyspnea Questionnaire
时间窗: Baseline up to 1 month post-treatment
Will be assessed per the American Thoracic Society (ATS) Dyspnea Questionnaire. The ATS Dyspnea Questionnaire is a 5-item self-report measure of dyspnea with higher scores indicating greater severity. This scale was developed for epidemiological research and is a common, brief clinical measure of dyspnea. Items are summed with scores ranging from 0-5. Responses of 0 indicate no dyspnea while responses ≥1 indicate experiences of dyspnea.
Change in acceptability of Take a Breath (TAB)
时间窗: Baseline up to 1 month post-treatment
Will be based on patient satisfaction scores using the Client Satisfaction Questionnaire, and will be determined to be acceptable if patient satisfaction scores at least "moderately" satisfied. To determine change over time in TAB, each analysis will include: covariates selected based on significant spearman correlation with outcomes, time (fixed), and time (random). To determine a differential rate of change in outcomes between TAB and treatment as usual (TAU), each analysis will include: covariates selected based on significant spearman correlation with outcomes, time (fixed), time (random), condition (fixed) and the fixed interaction between time and condition (time x condition).
Change in tolerability of TAB
时间窗: Baseline up to 1 month post-treatment
Will be based on the change in dyspnea symptoms from pre- to post-treatment, and determined to be tolerable if there is not a significant increase in dyspnea symptoms at post-treatment. To determine change over time in TAB, each analysis will include: covariates selected based on significant spearman correlation with outcomes, time (fixed), and time (random). To determine a differential rate of change in outcomes between TAB and TAU, each analysis will include: covariates selected based on significant spearman correlation with outcomes, time (fixed), time (random), condition (fixed) and the fixed interaction between time and condition (time x condition).
Feasibility of TAB
时间窗: Up to 1 month post-treatment
Based on patient enrollment (% of eligible patients enrolled to the study) and treatment adherence (% of patients retained in the study)
次要结局
- Catastrophic thoughts related to dyspnea(Up to 1 month post-treatment)
- Mood disturbance(Up to 1 month post-treatment)
- Physical activity using International Physical Activity Questionnaire (IPAQ)(Up to 1 month post-treatment)
研究者
Barbara Andersen
Principal Investigator
Ohio State University Comprehensive Cancer Center