Localized Lung CarcinomaNCT06869447
New York Better Breathing Study
A study testing Biospecimen Collection, Electronic Health Record Review and Medical Device Usage and Evaluation in people with Localized Lung Carcinoma and Stage I Lung Cancer AJCC v8, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Localized Lung Carcinoma, Stage I Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8
- What is being tested?
- Biospecimen Collection, Electronic Health Record Review and Medical Device Usage and Evaluation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2026to 15 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Andrew D. Ray, 716-845-2381, Andrew.Ray@RoswellPark.org
Andrew D. Ray
About this study
Official title: Lung Cancer Better Breathing Study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Localized Lung Carcinoma, Stage I Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8
- Being tested
- Biospecimen Collection, Electronic Health Record Review, Medical Device Usage and Evaluation, Questionnaire Administration, Respiratory Muscle Training
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Electronic Health Record ReviewOther
Ancillary studies
Medical Device Usage and EvaluationOther
Use Power Lung breathing device
Questionnaire AdministrationOther
Ancillary studies
Respiratory Muscle TrainingProcedure or surgery
Also called RMT
Participate in RMT sessions
Sham InterventionProcedure or surgery
Also called Sham Comparator
Participate in sham sessions
| Study group | Role | What they receive |
|---|---|---|
| Group I (moderate/high intensity RMT) | Experimental | 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. Receives: Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration; Procedure: Respiratory Muscle Training |
| Group II (low intensity sham RMT) | Sham comparator | 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. Receives: Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration; Procedure: Sham Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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".
Measured: 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-.
Measured: 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.
Measured: Prior to start of 12 week program and after the end of the 12 week program
Secondary outcomes (16)
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.
Measured: Up to 12 weeks
Attrition rate (Feasibility) (Aim 1)
An acceptable attrition rate will be defined as < 20%.
Measured: At 6 and 12 weeks
Patient-reported barriers to and facilitators of participation and sustained participation (Feasibility) (Aim 1)
Measured: At 6 and 12 weeks
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.
Measured: At 6 and 12 weeks
Satisfaction with RMT and RMT-sham sessions (Aim 1)
Will be evaluated by a survey assessment using patient-reported satisfaction with different intervention components using 0 to 10 Likert rating scales.
Measured: At 6 and 12 weeks
Exercise related dyspnea (Aim 2)
Will be assessed immediately following performance tests with the 0-10 Borg scale. 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.
Measured: Up to 3 months follow-up
Change in general quality of life (QoL) (Aim 2)
Will be assessed using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-30. 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.
Measured: Through study completion up to 7 months
Change in disease-specific QoL (Aim 2)
Will be assessed using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13. 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.
Measured: Through study completion up to 7 months
Change in 2-minute step test (Aim 2)
Will be Will be assessed to measure cardiorespiratory fitness that correlates with the 6-minute walk test. 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.
Measured: Through study completion up to 7 months
Change in 30 second sit-to-stand test (Aim 2)
Will be assessed to measure lower extremity strength. 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.
Measured: Through study completion up to 7 months
Change in sleep (Aim 2)
Will be assessed using the Pittsburgh Sleep Quality Index and Epworth daytime sleepiness scale. 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.
Measured: Through study completion up to 7 months
Change in leisure-time physical activity (Aim 2)
Will be assessed using the Godin Leisure-Time Exercise 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.
Measured: Through study completion up to 7 months
Change in physical activity and daily steps (Aim 2)
Will be objectively monitored with an activity tracker. Fitness trackers will be synchronized during weekly follow-ups. 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.
Measured: Through study completion up to 7 months
Change in pain (Aim 2)
Will be assessed using pain questions taken from the Patient-Reported Outcomes Measurement Information System-29 questionnaire which assess pain intensity and interference. 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.
Measured: Through study completion up to 7 months
Change in peak inspiratory and expiratory muscle strength (Aim 2)
Will be assessed using pa hand-held monometer. 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.
Measured: Through study completion up to 7 months
High-sensitivity C-reactive protein (Aim 3)
Will be measured with a Roche COBAS 8000 chemistry analyzer.
Measured: Prior to start of 12 week program and after the end of the 12 week program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start20 Apr 2026
- Primary completion15 Apr 2028 (estimated)
- Study completion15 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized Lung CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew D Ray, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869447
- Sponsor's protocol ID
- I-3969424
- Other IDs
- NCI-2025-01035, I-3969424
- Status last verified
- Oct 2026
- First submitted
- 27 Feb 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Cancer Better Breathing Study
- ClinicalTrials.gov ID
- NCT06869447
- Acronym / sponsor ID
- I-3969424
- Conditions
- Localized Lung Carcinoma, Stage I Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 15 Apr 2028 (estimated)
- Study completion
- 15 Apr 2028 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (moderate/high intensity RMT) | Experimental | Procedure: Biospecimen Collection, Other: Electronic Health Record Review, Other: Medical Device Usage and Evaluation, Other: Questionnaire Administration, Procedure: Respiratory Muscle TrainingPatients 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 (low intensity sham RMT) | Sham comparator | Procedure: Biospecimen Collection, Other: Electronic Health Record Review, Other: Medical Device Usage and Evaluation, Other: Questionnaire Administration, Procedure: Sham InterventionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (4 listed)
- 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).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Group I (moderate/high intensity RMT), Group II (low intensity sham RMT) |
| Electronic Health Record ReviewAncillary studies | Other | Group I (moderate/high intensity RMT), Group II (low intensity sham RMT) |
| Medical Device Usage and EvaluationUse Power Lung breathing device | Other | Group I (moderate/high intensity RMT), Group II (low intensity sham RMT) |
| Questionnaire AdministrationAncillary studies | Other | Group I (moderate/high intensity RMT), Group II (low intensity sham RMT) |
| Respiratory Muscle TrainingAlso: RMTParticipate in RMT sessions | Procedure or surgery | Group I (moderate/high intensity RMT) |
| Sham InterventionAlso: Sham ComparatorParticipate in sham sessions | Procedure or surgery | Group II (low intensity sham RMT) |
Primary outcome
Percentage of patients who complete at least 3 respiratory muscle training (RMT) sessions/week (Compliance) (Aim 1)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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 dyspena (Aim 2)- Functional Assessment of Chronic Illness Therapy (FACIT) dyspnea
Time frame: 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.
Change in cancer-related fatigue (Aim 2) - Brief Fatigue Inventory
Time frame: 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
Time frame: 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".
Circulating levels of myeloid-derived suppressor cells (MDSCs) (Aim 3)
Time frame: 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)
Time frame: 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.
16 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew D Ray principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biospecimen Collection, Electronic Health Record Review and Medical Device Usage and Evaluation in people with Localized Lung Carcinoma and Stage I Lung Cancer AJCC v8, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who complete at least 3 respiratory muscle training (RMT) sessions/week (Compliance) (Aim 1) (time frame: Up to 12 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.