Lung Cancer Better Breathing Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percentage of patients who complete at least 3 respiratory muscle training (RMT) sessions/week (Compliance) (Aim 1)
研究概览
简要总结
This clinical trial evaluates the effects of whether breathing exercises at home can reduce symptoms and help stage I-III lung cancer survivors stay active. Over 70% of lung cancer survivors have trouble breathing, feel tired, and have lower levels of fitness. This is often because their breathing muscles are weaker after surgery. Many survivors find it hard to exercise, which affects their quality of life and overall survival. A training program to strengthen these muscles might reduce breathing problems, lower fatigue, and improve quality of life. Staying active could also help boost the immune system to fight cancer. Respiratory muscle training (RMT) involves a series of breathing and other exercises that are performed to improve the function of the respiratory muscles through resistance and endurance training. Participating in a home-based RMT intervention may reduce symptoms from cancer or treatment in lung cancer survivors.
详细描述
PRIMARY OBJECTIVES:
I. Determine the feasibility of delivering a home-based RMT program to Black and White lung cancer survivors.
II. Determine the effects of RMT on symptom management (quality of life [QoL], fatigue, dyspnea, sleep, etc.), performance (respiratory muscle and lower extremity strength), and physical activity in Black and White lung cancer survivors.
III. Determine if RMT improves cancer related anti-tumor activity (T-cell function) and diminishes markers of immunosuppression (myeloid-derived suppressor cells [MDSCs], regulatory T cells) and inflammation (high-sensitivity C-reactive protein, (hsCRP) in circulation.
OUTLINE: Patients are randomized to 1 of 2 groups.
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 (Participant)
盲法说明
The patients will be blinded to their group assignment.
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
- •Age ≥ 18 years of age.
- •Able to speak, read and comprehend the English language
- •Self-identify as non-Hispanic Black or White.
- •Are < 24 months of histologically confirmed invasive, non-metastatic, lung cancer diagnosis.
- •Have received surgical treatment (primarily stage I, II and III) and have completed all cancer treatments (surgery, chemotherapy, radiation).
- •Willing to provide biospecimen samples for the study (blood) which will be collected in the comfort of the patient's home by a mobile phlebotomy group.
- •Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
排除标准
- •Participant has in situ (stage 0) or metastatic (stage IV) disease at study entry.
- •Has contraindications for respiratory muscle training (e.g., recent pulmonary embolism, aortic aneurysm, current pneumothorax).
- •Is actively engaging in a structured exercise program and/or meeting exercise guidelines.
- •Unwilling or unable to follow protocol requirements.
- •Any condition which in the investigator's opinion deems the participant an unsuitable candidate to participate in the study.
研究组 & 干预措施
Group I (moderate/high intensity RMT)
Patients participate in home-based/virtually supervised and unsupervised moderate/high intensity RMT sessions consisting of three sets of 15 breaths using the Power Lung device over 20 to 30 minutes per session, 5 days per week for 12 weeks. Patients also undergo blood sample collection throughout the study.
干预措施: Medical Device Usage and Evaluation (Other)
Group I (moderate/high intensity RMT)
Patients participate in home-based/virtually supervised and unsupervised moderate/high intensity RMT sessions consisting of three sets of 15 breaths using the Power Lung device over 20 to 30 minutes per session, 5 days per week for 12 weeks. Patients also undergo blood sample collection throughout the study.
干预措施: Questionnaire Administration (Other)
Group I (moderate/high intensity RMT)
Patients participate in home-based/virtually supervised and unsupervised moderate/high intensity RMT sessions consisting of three sets of 15 breaths using the Power Lung device over 20 to 30 minutes per session, 5 days per week for 12 weeks. Patients also undergo blood sample collection throughout the study.
干预措施: Biospecimen Collection (Procedure)
Group I (moderate/high intensity RMT)
Patients participate in home-based/virtually supervised and unsupervised moderate/high intensity RMT sessions consisting of three sets of 15 breaths using the Power Lung device over 20 to 30 minutes per session, 5 days per week for 12 weeks. Patients also undergo blood sample collection throughout the study.
干预措施: Electronic Health Record Review (Other)
Group I (moderate/high intensity RMT)
Patients participate in home-based/virtually supervised and unsupervised moderate/high intensity RMT sessions consisting of three sets of 15 breaths using the Power Lung device over 20 to 30 minutes per session, 5 days per week for 12 weeks. Patients also undergo blood sample collection throughout the study.
干预措施: Respiratory Muscle Training (Procedure)
Group II (low intensity sham RMT)
Patients participate in home-based/virtually supervised and unsupervised low intensity sham RMT sessions using the Power Lung breathing device over 20 to 30 minutes per session, 5 days per week for 12 weeks. Patients also undergo blood sample collection throughout the study. Patients may optionally participate in the moderate/high intensity RMT session for 6 weeks upon study completion.
干预措施: Biospecimen Collection (Procedure)
Group II (low intensity sham RMT)
Patients participate in home-based/virtually supervised and unsupervised low intensity sham RMT sessions using the Power Lung breathing device over 20 to 30 minutes per session, 5 days per week for 12 weeks. Patients also undergo blood sample collection throughout the study. Patients may optionally participate in the moderate/high intensity RMT session for 6 weeks upon study completion.
干预措施: Electronic Health Record Review (Other)
Group II (low intensity sham RMT)
Patients participate in home-based/virtually supervised and unsupervised low intensity sham RMT sessions using the Power Lung breathing device over 20 to 30 minutes per session, 5 days per week for 12 weeks. Patients also undergo blood sample collection throughout the study. Patients may optionally participate in the moderate/high intensity RMT session for 6 weeks upon study completion.
干预措施: Medical Device Usage and Evaluation (Other)
Group II (low intensity sham RMT)
Patients participate in home-based/virtually supervised and unsupervised low intensity sham RMT sessions using the Power Lung breathing device over 20 to 30 minutes per session, 5 days per week for 12 weeks. Patients also undergo blood sample collection throughout the study. Patients may optionally participate in the moderate/high intensity RMT session for 6 weeks upon study completion.
干预措施: Questionnaire Administration (Other)
Group II (low intensity sham RMT)
Patients participate in home-based/virtually supervised and unsupervised low intensity sham RMT sessions using the Power Lung breathing device over 20 to 30 minutes per session, 5 days per week for 12 weeks. Patients also undergo blood sample collection throughout the study. Patients may optionally participate in the moderate/high intensity RMT session for 6 weeks upon study completion.
干预措施: Sham Intervention (Procedure)
结局指标
主要结局
Percentage of patients who complete at least 3 respiratory muscle training (RMT) sessions/week (Compliance) (Aim 1)
时间窗: Up to 12 weeks
Compliance will be estimated using 90% confidence intervals (CIs) obtained by Jeffreys' prior method. Will be modeled as a function of time (e.g., week) and prespecified exogenous factors (e.g., baseline age, pre-intervention dyspnea scores, self-reported history of exercise, lung cancer treatment received, treatment side-effects) using a GEE (Generalized Estimating Equations) logistic regression model (autoregressive covariance structure). Will also be explored with data stratified by race and gender.
Proportion of planned sessions completed (Adherence) (Aim 1)
时间窗: Up to 12 weeks
Adherence will be defined as the number of sessions completed divided by the total number of sessions planned (70% of the 42/60 sessions). Will be estimated using 90% CIs obtained by Jeffreys' prior method. Will also be explored with data stratified by race and gender.
Proportion of total completed to total planned cumulative dose (Tolerability) (Aim 1)
时间窗: Up to 12 weeks
Tolerability ratio will be assessed using Relative Dose Intensity and rate of lost to follow-up and discontinuation.
Inspiratory muscle strength (Aim 2)
时间窗: Up to 12 weeks
Will perform remote respiratory muscle strength testing with a handheld device (Leaton, China) to measure diaphragm strength. All will be done per American Thoracic Society guidelines. A minimum of 3 trials with 5% of each will be required. Will be summarized using the appropriate descriptive statistics and graphical summaries. Continuous variables will be summarized using the mean, median, standard deviation, and percentiles. Categorical variables will be summarized using frequencies and relative frequencies. Baseline demographic and clinical characteristics may be compared between study arms using the Mann-Whitney U and Fisher's exact tests, as appropriate. Will also be assessed using linear mixed models (LMMs).
Change in dyspnea (Aim 2)-Dyspnea-12 survey
时间窗: Through study completion up to 7 months
Will be measured using the Dyspnea-12 survey survey that measures recent breathlessness with 12 questions related to dyspnea, each evaluated on a scale of 0-4 (0=none, 1=mild, 2=moderate, 3=severe) that indicate how troubled people are by each of these 12 topics, for a total possible score ranging from 0 to 36, where lower scores relate to better outcomes.- Will be summarized using the appropriate descriptive statistics and graphical summaries. Continuous variables will be summarized using the mean, median, standard deviation, and percentiles. Categorical variables will be summarized using frequencies and relative frequencies. Baseline demographic and clinical characteristics may be compared between study arms using the Mann-Whitney U and Fisher's exact tests, as appropriate. Will also be assessed using LMMs.
Change in cancer-related fatigue (Aim 2) - Brief Fatigue Inventory
时间窗: Through study completion up to 7 months
This 9-item scale assesses the severity and interference of fatigue based on a 0 (no fatigue) to 10 (greatest fatigue) scale
Change in cancer related Fatigue (Aim 2) - FACIT fatigue scale
时间窗: Through study completion up to 7 months
s a 13-item patient-reported measure of fatigue. Items are scored on a 0 - 4 response scale with anchors ranging from "Not at all" to "Very much so".
Change in dyspena (Aim 2)- Functional Assessment of Chronic Illness Therapy (FACIT) dyspnea
时间窗: Through study completion up to 7 months
the Functional Assessment of Chronic Illness Therapy (FACIT) dyspnea questionnaire. Will be summarized using the appropriate descriptive statistics and graphical summaries. Continuous variables will be summarized using the mean, median, standard deviation, and percentiles. Categorical variables will be summarized using frequencies and relative frequencies. Baseline demographic and clinical characteristics may be compared between study arms using the Mann-Whitney U and Fisher's exact tests, as appropriate. Will also be assessed using LMMs.
Circulating levels of myeloid-derived suppressor cells (MDSCs) (Aim 3)
时间窗: Prior to start of 12 week program and after the end of the 12 week program
All flow cytometry assessments will be performed in the Flow \& Image Cytometry Shared Resource (FICSR). A key outcome will be the quantification of immunosuppressive MDSCs, which play an important role in lung cancer prognosis. Myeloid cells (CD45+ CD11b+CD33+) will be assessed for both major human MDSC subsets, polymorphonuclear myeloid-derived suppressor cells, and monocytic MDSCs. For analysis of peripheral blood mononuclear cells, cells will first be collected over a Ficoll-Hypaque gradient, where both MDSC subsets, as well as all other immune populations analyzed will reside. Polymorphonuclear-MDSCs will be defined as CD11b+CD33+HLA-DR-CD14-CD15+CD66b+, whereas M-MDSCs will be defined as CD11b+CD33+HLA-DRlo/- CD14+CD15-CD66b-.
Circulating levels conventional T cell populations (CD3+) (Aim 3)
时间窗: Prior to start of 12 week program and after the end of the 12 week program
All flow cytometry assessments will be performed in the FICSR. Will be stratified based on CD4 or CD8 expression, and will be further defined by their differentiation, activation, or exhaustion states.
次要结局
- Proportion of eligible patients who elected to participate in the trial (Acceptability) (Aim 1)(Up to 12 weeks)
- Attrition rate (Feasibility) (Aim 1)(At 6 and 12 weeks)
- Patient-reported barriers to and facilitators of participation and sustained participation (Feasibility) (Aim 1)(At 6 and 12 weeks)
- Barriers to and facilitators (Aim 1)(At 6 and 12 weeks)
- Satisfaction with RMT and RMT-sham sessions (Aim 1)(At 6 and 12 weeks)
- Exercise related dyspnea (Aim 2)(Up to 3 months follow-up)
- Change in general quality of life (QoL) (Aim 2)(Through study completion up to 7 months)
- Change in disease-specific QoL (Aim 2)(Through study completion up to 7 months)
- Change in 2-minute step test (Aim 2)(Through study completion up to 7 months)
- Change in 30 second sit-to-stand test (Aim 2)(Through study completion up to 7 months)
- Change in sleep (Aim 2)(Through study completion up to 7 months)
- Change in leisure-time physical activity (Aim 2)(Through study completion up to 7 months)
- Change in physical activity and daily steps (Aim 2)(Through study completion up to 7 months)
- Change in pain (Aim 2)(Through study completion up to 7 months)
- Change in peak inspiratory and expiratory muscle strength (Aim 2)(Through study completion up to 7 months)
- High-sensitivity C-reactive protein (Aim 3)(Prior to start of 12 week program and after the end of the 12 week program)