Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 247
- 试验地点
- 4
- 主要终点
- Modified Medical Research Council Dyspnea Scale (mMRCDS)
研究概览
简要总结
This research study is evaluating a behavioral intervention designed to help people with advanced lung cancer manage dyspnea (i.e., breathlessness or shortness-of-breath).
详细描述
Many individuals with advanced lung cancer experience debilitating breathlessness at some point during the course of their illness. Unfortunately, few interventions exist to treat this distressing symptom of cancer.
The purpose of this study is to test the efficacy of a brief behavioral intervention may help relieve breathlessness in individuals with advanced lung cancer. Participants will have a 50/50 chance of receiving the behavioral intervention or standard care. The principal investigator of the study, Dr. Joseph Greer, is a licensed clinical psychologist who has trained oncology nurses in how to deliver the behavioral intervention. The oncology nurses will meet with participants during their outpatient oncology appointments, such as chemotherapy infusions, to review the behavioral skills that may help with breathlessness. This intervention involves no medications but rather teaches patients skills for breathing control and relaxation of the body.
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
- Single (Outcomes Assessor)
盲法说明
Research staff collecting patient-reported measures will be blind to study assignment group
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
- •A diagnosis of either NSCLC, SCLC, or mesothelioma, not being treated with curative intent
- •Self-reported shortness of breath (a score of 2 or greater on the Modified Medical Research Council Dyspnea Scale)
- •Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 (asymptomatic) to 2 (symptomatic and in bed <50% of day)
- •The ability to read and respond to questions English
- •Primary cancer care at the Massachusetts General Hospital (MGH) Cancer Center or Dana-Farber Cancer Institute (DFCI)
- •Age >18 years
排除标准
- •Cognitive or psychiatric conditions prohibiting study consent or participation.
- •A treating clinician who reports that the patient is inappropriate for the study
结局指标
主要结局
Modified Medical Research Council Dyspnea Scale (mMRCDS)
时间窗: 8 weeks
Compare the difference between study groups in the Modified Medical Research Council Dyspnea Scale severity score at 8 weeks. The Modified Medical Research Council Dyspnea Scale scores range from 0 (minimum) to 4 (maximum), with higher scores indicating more severe dyspnea.
Cancer Dyspnoea Scale (CDS)
时间窗: 8 weeks
Compare the difference between study groups in the Cancer Dyspnoea Scale scores at 8 weeks. The Cancer Dyspnoea Scale scores range from 0 (minimum) to 48 (maximum), with higher scores indicating worse dyspnea.
次要结局
- Functional Assessment of Cancer Therapy - Lung (FACT-L)(8 weeks)
- Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale(8 weeks)
- Hospital Anxiety and Depression Scale (HADS) - Depression Subscale(8 weeks)
- Activity Level (Self-report: Godin-Shephard Leisure Time Physical Activity Questionnaire)(8 weeks)
- Activity Level (Objective Measure: Actigraphy)(8 weeks)
研究者
Joseph A. Greer, Ph.D.
Associate Professor of Psychology
Massachusetts General Hospital