New York Better Breathing Study for Lung Cancer Survivors
This study, called the New York Better Breathing Study, is looking at whether breathing exercises done at home can help lung cancer survivors with breathing problems and fatigue. Many people who have had lung cancer surgery find their breathing muscles are weaker, making it hard to stay active. This study will have you use a device called Power Lung for respiratory muscle training (RMT) to see if it can improve your breathing, reduce tiredness, and boost your quality of life. We are looking for people aged 18 or older who have been diagnosed with non-metastatic (cancer that hasn't spread) lung cancer (stages I, II, or III) within the last two years and have completed all their cancer treatments. The main goal is to see how well people can stick to the breathing exercise program and how much of the training they complete over 12 weeks.
- Study design
- This study is an interventional study with a planned enrollment of 100 participants. You will be randomly assigned to one of two groups: one doing moderate/high intensity breathing exercises, and the other doing low intensity exercises.
- What's involved
- You will participate in home-based breathing exercise sessions using the Power Lung device for 20-30 minutes, 5 days a week for 12 weeks. You will also provide blood samples throughout the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary goals of the study are measured up to 12 weeks.
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New York Better Breathing Study
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Andrew D Ray · PRINCIPAL_INVESTIGATOR · Roswell Park Cancer Institute
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Percentage of patients who complete at least 3 respiratory muscle training (RMT) sessions/week (Compliance) (Aim 1)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)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)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)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 surveyThrough 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 dyspena (Aim 2)- Functional Assessment of Chronic Illness Therapy (FACIT) dyspneaThrough 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.
- Change in cancer-related fatigue (Aim 2) - Brief Fatigue InventoryThrough 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 scaleThrough 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".
- Circulating levels of myeloid-derived suppressor cells (MDSCs) (Aim 3)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)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.