New York Better Breathing Study

May 27, 2026 updated by: Roswell Park Cancer Institute

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute
        • Contact:
        • Principal Investigator:
          • Andrew D. Ray

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Questionnaire Administration
Ancillary studies
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Other: Electronic Health Record Review
Ancillary studies
Other: Medical Device Usage and Evaluation
Use Power Lung breathing device
Procedure: Respiratory Muscle Training
Participate in RMT sessions
Other Names:
  • RMT
Sham Comparator: 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.
Other: Questionnaire Administration
Ancillary studies
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Other: Electronic Health Record Review
Ancillary studies
Other: Medical Device Usage and Evaluation
Use Power Lung breathing device
Procedure: Sham Intervention
Participate in sham sessions
Other Names:
  • Sham Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12 weeks
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.
Up to 12 weeks
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.
Up to 12 weeks
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).
Up to 12 weeks
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.
Through study completion up to 7 months
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.
Through study completion up to 7 months
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
Through study completion up to 7 months
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".
Through study completion up to 7 months
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-.
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)
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.
Prior to start of 12 week program and after the end of the 12 week program

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of eligible patients who elected to participate in the trial (Acceptability) (Aim 1)
Time Frame: Up to 12 weeks
Enrollment rate will be summarized using frequencies and relative frequencies overall and by race and ethnicity.
Up to 12 weeks
Attrition rate (Feasibility) (Aim 1)
Time Frame: At 6 and 12 weeks
An acceptable attrition rate will be defined as < 20%.
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
At 6 and 12 weeks
Barriers to and facilitators (Aim 1)
Time Frame: At 6 and 12 weeks
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.
At 6 and 12 weeks
Satisfaction with RMT and RMT-sham sessions (Aim 1)
Time Frame: At 6 and 12 weeks
Will be evaluated by a survey assessment using patient-reported satisfaction with different intervention components using 0 to 10 Likert rating scales.
At 6 and 12 weeks
Exercise related dyspnea (Aim 2)
Time Frame: Up to 3 months follow-up
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.
Up to 3 months follow-up
Change in general quality of life (QoL) (Aim 2)
Time Frame: Through study completion up to 7 months
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.
Through study completion up to 7 months
Change in disease-specific QoL (Aim 2)
Time Frame: Through study completion up to 7 months
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.
Through study completion up to 7 months
Change in 2-minute step test (Aim 2)
Time Frame: Through study completion up to 7 months
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.
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
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.
Through study completion up to 7 months
Change in sleep (Aim 2)
Time Frame: Through study completion up to 7 months
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.
Through study completion up to 7 months
Change in leisure-time physical activity (Aim 2)
Time Frame: Through study completion up to 7 months
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.
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
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.
Through study completion up to 7 months
Change in pain (Aim 2)
Time Frame: Through study completion up to 7 months
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.
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
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.
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
Will be measured with a Roche COBAS 8000 chemistry analyzer.
Prior to start of 12 week program and after the end of the 12 week program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Investigators

  • Principal Investigator: Andrew D Ray, Roswell Park Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2026

Primary Completion (Estimated)

April 15, 2028

Study Completion (Estimated)

April 15, 2028

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 11, 2025

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I-3969424 (Other Identifier: Roswell Park Cancer Institute)
  • NCI-2025-01035 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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