Pulmonary Rehabilitation in Locally Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Percent improvement in the 6 minute walk from prior to post PR
研究概览
简要总结
This randomized clinical trial studies pulmonary rehabilitation in improving lung function in patients with locally advanced non-small cell lung cancer undergoing chemoradiation. Individualized exercise rehabilitation programs may reduce breathing problems and improve quality of life in patients with non-small cell lung cancer. It is not yet known whether pulmonary rehabilitation is more effective when started during or after cancer treatment.
详细描述
PRIMARY OBJECTIVES:
I. To determine feasibility of pulmonary rehabilitation (PR) in patients with locally advanced unresectable non-small cell lung cancer (NSCLC) undergoing definite chemotherapy and radiation therapy.
II. To measure exercise capacity and respiratory symptoms in lung cancer patients receiving chemotherapy and radiation before and after pulmonary rehabilitation.
III. To compare if there are any differences in symptom relief, exercise capacity, and cancer treatment tolerability between performing pulmonary rehabilitation during chemo-radiation versus after completion of lung cancer treatment.
OUTLINE: Patients are randomized to 1 of 2 arms.
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
- •Patients who have been diagnosed with locally advanced unresectable NSCLC undergoing definite chemo-radiation with curative intent
- •Patients must be able to sign informed consent
- •Patients who qualify for pulmonary rehabilitation as part of the standard of care and are covered by medical insurance
- •Patients must be able to ambulate a minimum of 100 feet prior to enrollment in pulmonary rehab
- •Patients must be willing and able to travel to the pulmonary rehabilitation site at the Morehouse Medical Plaza
排除标准
- •Tumor resection candidates
- •If survival is deemed less than 6 months for any medical condition
- •If they have angina or unstable coronary disease
- •Congestive heart failure refractory to medical management
- •Malignancy with bone instability
结局指标
主要结局
Percent improvement in the 6 minute walk from prior to post PR
时间窗: Baseline to up to 8 weeks
Either a two-sided t-test or a Wilcoxon-rank sum test will be used to test the difference in the improvement of the 6 minute walk depending on the distribution. This test will be used to compare the difference in improvement between PR during chemo-radiation of NSCLC patients and PR 8 weeks post chemo-radiation. Linear regression will be used to estimate which clinical characteristics and patient demographics are associated with improvement in 6 minute walk. The study population will be described using means and standard deviations or medians and the interquartile range.
次要结局
- Percent improvement in the St. George Respiratory Questionnaire (SGRQ) score(Baseline to up to 8 weeks)
- Feasibility of the program, based on number of patients attending the sessions throughout the 8 weeks(Up to 8 weeks)