New York Better Breathing Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoswell Park Cancer Institute

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Electronic Health Record Review

    Other intervention

    Ancillary studies

  • Medical Device Usage and Evaluation

    Other intervention

    Use Power Lung breathing device

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Respiratory Muscle Training

    Procedure/Surgery

    Participate in RMT sessions

  • Sham Intervention

    Procedure/Surgery

    Participate in sham sessions

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Group I (moderate/high intensity RMT)Experimental treatment 5 interventions
Group B: Group II (low intensity sham RMT)Sham comparator 5 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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.

Time frame
Up to 12 weeks
2

Attrition rate (Feasibility) (Aim 1)

An acceptable attrition rate will be defined as \< 20%.

Time frame
At 6 and 12 weeks
3

Patient-reported barriers to and facilitators of participation and sustained participation (Feasibility) (Aim 1)

Time frame
At 6 and 12 weeks
4

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.

Time frame
At 6 and 12 weeks

Other outcomes

Sponsors and contacts

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