Pulmonary Rehabilitation in Advanced Lung Cancer Survivors
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Change in functional capacity of LCS with advanced NSCLC, as measured by the 6-minute walk test (6MWT)
研究概览
简要总结
This study is for people who have previously been diagnosed with advanced stage non-small cell lung cancer (NSCLC). Many people with advanced stage NSCLC have trouble breathing and feel tired. People may be eligible for this study if they have advanced stage NSCLC and feel short of breath some of the time. NSCLC survivors may also experience things like fatigue and a lower quality of life. Pulmonary rehabilitation is a type of supportive treatment that may improve these symptoms.
This study has two parts. The first part is a randomized trial where half of the participants receive eight weeks of pulmonary rehabilitation. The other half of participants do not do pulmonary rehabilitation and instead receive the treatment that their doctors would normally recommend. The purpose of this part of the research study is to understand if pulmonary rehabilitation can help people with advanced stage NSCLC have better functioning and less shortness of breath.
The other part of the research study is an interview study. The purpose of doing interviews is to understand any challenges or obstacles that people with advanced stage NSCLC may have regarding pulmonary rehabilitation, as well as oncology care providers have with their participants going to pulmonary rehabilitation.
详细描述
Lung cancer (LC) is the second most common cancer in the world, (1) and the third most common cancer in the United States of America (USA) (2). Because more lung cancer screenings are being done (3-5) and because there have been advances in treatments, people will all stages of LC are living longer, including those with advanced LC. Research has shown that fatigue and breathing issues are commonly experienced by LCS (6). These symptoms can hurt the long-term health and quality of life of LCS (6-8). Currently, there are not many interventions that are used to help these symptoms for LCS.
For people with non-cancer-related respiratory disease, like chronic obstructive pulmonary disease (COPD), a type of supportive treatment called pulmonary rehabilitation (PR) can improve symptoms like difficulty breathing, fatigue, difficulty exercising, and health-related quality of life (9-11). PR is a holistic treatment plan that includes a full assessment and is then personalized to fit each person's needs. This could include things like exercise training, education, and behavior change (12). PR is considered standard-of-care for people with COPD (13). PR includes physical activity, which is something that is encouraged in all cancer survivors.
There is not much research that talks about the barriers to physical activity in survivors of lung cancer, although fatigue may be one of the most significant ones (14). Doctors may also not feel comfortable encouraging physical activities in people with lung cancer due to concerns about the safety and feasibility in exercise in people with lung cancer (15). However, PR is safe and effective in people with chronic pulmonary conditions, with well-established pathways and programs for these people.
As stated above, LCS have persistent fatigue and difficulty breathing, which is often worse in people who have metastatic LC. There is limited, high-quality evidence supporting interventions designed specifically for LCS with advanced disease. PR is potentially a safe and available intervention to improve functional status in LCS with early stage disease, and more research is needed to understand its impact on LCS with metastatic NSCLC treated with modern therapies.
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
- •Participants must have histologically confirmed NSCLC, Stages III or IV treated with palliative intent
- •Adults ≥ 18 years of age
- •ECOG performance status ≤ 3
- •Clinical stability: defined as no clinical/radiographic progression within the last three months
- •Self-reported dyspnea, defined as score ≥ 2 on the modified Medical Research Council (mMRC) Dyspnea Scale
- •Participants must be fluent in written and spoken English
排除标准
- •Participants being treated with curative intent for locally advanced NSCLC or oligometastatic NSCLC with concurrent chemotherapy and radiation will be excluded
- •Participants have evidence of clinical and/or radiographic progression
- •Mental impairment leading to inability to complete study requirements
- •High risk of fracture or spine instability (Mirels score ≥7 or SINS ≥7)
- •Any of the following cardiac exclusion criteria:
- •Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
- •History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty or stenting within the past 6 months prior to the start of radiation therapy
- •Uncontrolled arrhythmias; individuals with rate-controlled atrial fibrillation for > 1 month prior to start of radiation therapy may be eligible
- •Acute myocarditis, pericarditis, or endocarditis
- •Acute pulmonary embolus or pulmonary infarction within the last 3 months
- •Acute thrombosis of lower extremities within the last 3 months
- •Suspected dissecting aneurysm
- •Pulmonary edema
- •Respiratory failure
- •Acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise
研究组 & 干预措施
Pulmonary Rehabilitation (PR)
干预措施: Pulmonary Rehabilitation (PR) (Behavioral)
Usual care
干预措施: No intervention: Usual care (Other)
Qualitative interviews
A subset of PR participants, a subset of participants who decline the randomized portion of the study, and a subset of medical care providers will participate in qualitative interviews to assess attitudes and barriers to PR.
结局指标
主要结局
Change in functional capacity of LCS with advanced NSCLC, as measured by the 6-minute walk test (6MWT)
时间窗: Baseline, 8 weeks
The 6MWT measures the distance (in meters) that a person can walk in 6 minutes, with higher values indicating greater functional capacity
Change in self-reported dyspnea and quality of life (QoL) in LCS with advanced NSCLC, as measured by the modified Borg scale (MBS)
时间窗: Baseline, 8 weeks
The MBS is a 1-question scale that is asked after the 6MWT, where participants rank their dyspnea (difficulty breathing) on a scale of 1-10, with greater values indicating greater difficulty.
Change in self-reported dyspnea and quality of life (QoL) in LCS with advanced NSCLC, as measured by the EORTC QLQ-C30
时间窗: Baseline, 8 weeks
The EORTC QLQ-C30 is a 30-question questionnaire that captures functional, symptom, global health status, and QoL domains. Questions are answered on a Likert scale with four choices ranging from "Not at all" to "Very much." Greater scores indicate lower quality of life.
Change in self-reported dyspnea and quality of life (QoL) in LCS with advanced NSCLC, as measured by the EORTC QLQ-LC29
时间窗: Baseline, 8 weeks
The EORTC QLQ-LC29 is a 29-question questionnaire that captures lung cancer-related symptoms and treatment side effects. Questions are answered on a Likert scale with four choices ranging from "Not at all" to "Very much." Greater scores indicate greater symptoms and side effects.
Change in quantity of cancer-related adverse events (AEs), as measured by the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
时间窗: Baseline, 8 weeks
Change in functional capacity of LCS with advanced NSCLC, as measured by the 6-minute walk test (6MWT)
时间窗: Baseline, 8 weeks
The 6MWT measures the distance (in meters) that a person can walk in 6 minutes, with higher values indicating greater functional capacity
Change in self-reported dyspnea and quality of life (QoL) in LCS with advanced NSCLC, as measured by the modified Borg scale (MBS)
时间窗: Baseline, 8 weeks
The MBS is a 1-question scale that is asked after the 6MWT, where participants rank their dyspnea (difficulty breathing) on a scale of 1-10, with greater values indicating greater difficulty.
Change in self-reported dyspnea and quality of life (QoL) in LCS with advanced NSCLC, as measured by the EORTC QLQ-C30
时间窗: Baseline, 8 weeks
The EORTC QLQ-C30 is a 30-question questionnaire that captures functional, symptom, global health status, and QoL domains. Questions are answered on a Likert scale with four choices ranging from "Not at all" to "Very much." Greater scores indicate lower quality of life.
Change in self-reported dyspnea and quality of life (QoL) in LCS with advanced NSCLC, as measured by the EORTC QLQ-LC29
时间窗: Baseline, 8 weeks
The EORTC QLQ-LC29 is a 29-question questionnaire that captures lung cancer-related symptoms and treatment side effects. Questions are answered on a Likert scale with four choices ranging from "Not at all" to "Very much." Greater scores indicate greater symptoms and side effects.
Change in quantity of cancer-related adverse events (AEs), as measured by the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
时间窗: Baseline, 8 weeks
次要结局
- Participants' barriers to pulmonary rehabilitation in LCS with advanced NSCLC, as measured by thematic findings from qualitative interviews(One-time interview between month 6 and 30)
- Thoracic oncology providers' barriers to referral to pulmonary rehabilitation, as measured by thematic findings from qualitative interviews(One-time interview between month 6 and 30)
- Participants' barriers to pulmonary rehabilitation in LCS with advanced NSCLC, as measured by thematic findings from qualitative interviews(One-time interview between month 6 and 30)
- Thoracic oncology providers' barriers to referral to pulmonary rehabilitation, as measured by thematic findings from qualitative interviews(One-time interview between month 6 and 30)