Lung Cancer Better Breathing Study
Summary
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.
Detailed description
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. GROUP I: 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. GROUP II: 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. After completion of study intervention, patients are followed up at 3 months.
Arms & interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- OtherElectronic Health Record Review
Ancillary studies
- OtherMedical Device Usage and Evaluation
Use Power Lung breathing device
- OtherQuestionnaire Administration
Ancillary studies
- ProcedureRespiratory Muscle Training
Participate in RMT sessions
- ProcedureSham Intervention
Participate in sham sessions
Outcome measures
Primary
Percentage of patients who complete at least 3 respiratory muscle training (RMT) sessions/week (Compliance) (Aim 1)
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.
Time frame: Up to 12 weeks
Proportion of planned sessions completed (Adherence) (Aim 1)
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.
Time frame: Up to 12 weeks
Proportion of total completed to total planned cumulative dose (Tolerability) (Aim 1)
Tolerability ratio will be assessed using Relative Dose Intensity and rate of lost to follow-up and discontinuation.
Time frame: Up to 12 weeks
Inspiratory muscle strength (Aim 2)
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).
Time frame: Up to 12 weeks
Change in dyspnea (Aim 2)-Dyspnea-12 survey
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.
Time frame: Through study completion up to 7 months
Change in dyspena (Aim 2)- Functional Assessment of Chronic Illness Therapy (FACIT) dyspnea
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.
Time frame: Through study completion up to 7 months
Change in cancer-related fatigue (Aim 2) - Brief Fatigue Inventory
This 9-item scale assesses the severity and interference of fatigue based on a 0 (no fatigue) to 10 (greatest fatigue) scale
Time frame: Through study completion up to 7 months
Change in cancer related Fatigue (Aim 2) - FACIT fatigue scale
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".
Time frame: Through study completion up to 7 months
Circulating levels of myeloid-derived suppressor cells (MDSCs) (Aim 3)
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-.
Time frame: Prior to start of 12 week program and after the end of the 12 week program
Circulating levels conventional T cell populations (CD3+) (Aim 3)
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.
Time frame: Prior to start of 12 week program and after the end of the 12 week program
Secondary
Proportion of eligible patients who elected to participate in the trial (Acceptability) (Aim 1)
Time frame: Up to 12 weeks
Attrition rate (Feasibility) (Aim 1)
Time frame: At 6 and 12 weeks
Patient-reported barriers to and facilitators of participation and sustained participation (Feasibility) (Aim 1)
Time frame: At 6 and 12 weeks
Barriers to and facilitators (Aim 1)
Time frame: At 6 and 12 weeks
Satisfaction with RMT and RMT-sham sessions (Aim 1)
Time frame: At 6 and 12 weeks
Exercise related dyspnea (Aim 2)
Time frame: Up to 3 months follow-up
Change in general quality of life (QoL) (Aim 2)
Time frame: Through study completion up to 7 months
Change in disease-specific QoL (Aim 2)
Time frame: Through study completion up to 7 months
Change in 2-minute step test (Aim 2)
Time frame: Through study completion up to 7 months
Change in 30 second sit-to-stand test (Aim 2)
Time frame: Through study completion up to 7 months
Change in sleep (Aim 2)
Time frame: Through study completion up to 7 months
Change in leisure-time physical activity (Aim 2)
Time frame: Through study completion up to 7 months
Change in physical activity and daily steps (Aim 2)
Time frame: Through study completion up to 7 months
Change in pain (Aim 2)
Time frame: Through study completion up to 7 months
Change in peak inspiratory and expiratory muscle strength (Aim 2)
Time frame: Through study completion up to 7 months
High-sensitivity C-reactive protein (Aim 3)
Time frame: Prior to start of 12 week program and after the end of the 12 week program
Eligibility criteria
Study locations (1)
Roswell Park Cancer Institute
Buffalo, New York, 14263