About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Electronic Health Record Review
Other interventionAncillary studies
Medical Device Usage and Evaluation
Other interventionUse Power Lung breathing device
Questionnaire Administration
Other interventionAncillary studies
Respiratory Muscle Training
Procedure/SurgeryParticipate in RMT sessions
Sham Intervention
Procedure/SurgeryParticipate in sham sessions
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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).
Secondary outcomes
Proportion of eligible patients who elected to participate in the trial (Acceptability) (Aim 1)
Enrollment rate will be summarized using frequencies and relative frequencies overall and by race and ethnicity.
Attrition rate (Feasibility) (Aim 1)
An acceptable attrition rate will be defined as \< 20%.
Patient-reported barriers to and facilitators of participation and sustained participation (Feasibility) (Aim 1)
Barriers to and facilitators (Aim 1)
Identified as important for influencing exercise behavior among cancer survivors will be examined by gender and race, particularly those identified by lung cancer survivors, including social determinants of health. Will primarily use quantifiable Likert scales to rate the importance of each facilitator and barrier. Open-ended items will be included to collect factors not captured through closed survey questions.
Sponsors and contacts
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