New York Better Breathing Study

Официальное название

Lung Cancer Better Breathing Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Biospecimen Collection
  Undergo blood sample collection
• Другое Electronic Health Record Review
  Ancillary studies
• Другое Medical Device Usage and Evaluation
  Use Power Lung breathing device
• Другое Questionnaire Administration
  Ancillary studies
• Процедура Respiratory Muscle Training
  Participate in RMT sessions
• Процедура Sham Intervention
  Participate in sham sessions

Первичные конечные точки

• Percentage of patients who complete at least 3 respiratory muscle training (RMT) sessions/week (Compliance) (Aim 1) [Срок оценки: Up to 12 weeks]
• Proportion of planned sessions completed (Adherence) (Aim 1) [Срок оценки: Up to 12 weeks]
• Proportion of total completed to total planned cumulative dose (Tolerability) (Aim 1) [Срок оценки: Up to 12 weeks]
• Inspiratory muscle strength (Aim 2) [Срок оценки: Up to 12 weeks]
• Change in dyspnea (Aim 2)-Dyspnea-12 survey [Срок оценки: Through study completion up to 7 months]
• Change in dyspena (Aim 2)- Functional Assessment of Chronic Illness Therapy (FACIT) dyspnea [Срок оценки: Through study completion up to 7 months]
• Change in cancer-related fatigue (Aim 2) - Brief Fatigue Inventory [Срок оценки: Through study completion up to 7 months]
• Change in cancer related Fatigue (Aim 2) - FACIT fatigue scale [Срок оценки: Through study completion up to 7 months]
• Circulating levels of myeloid-derived suppressor cells (MDSCs) (Aim 3) [Срок оценки: 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) [Срок оценки: Prior to start of 12 week program and after the end of the 12 week program]

Вторичные конечные точки (12)

• Proportion of eligible patients who elected to participate in the trial (Acceptability) (Aim 1) [Срок оценки: Up to 12 weeks]
• Attrition rate (Feasibility) (Aim 1) [Срок оценки: At 6 and 12 weeks]
• Patient-reported barriers to and facilitators of participation and sustained participation (Feasibility) (Aim 1) [Срок оценки: At 6 and 12 weeks]
• Barriers to and facilitators (Aim 1) [Срок оценки: At 6 and 12 weeks]
• Satisfaction with RMT and RMT-sham sessions (Aim 1) [Срок оценки: At 6 and 12 weeks]
• Exercise related dyspnea (Aim 2) [Срок оценки: Up to 3 months follow-up]
• Change in general quality of life (QoL) (Aim 2) [Срок оценки: Through study completion up to 7 months]
• Change in disease-specific QoL (Aim 2) [Срок оценки: Through study completion up to 7 months]
• Change in 2-minute step test (Aim 2) [Срок оценки: Through study completion up to 7 months]
• Change in 30 second sit-to-stand test (Aim 2) [Срок оценки: Through study completion up to 7 months]
• Change in sleep (Aim 2) [Срок оценки: Through study completion up to 7 months]
• Change in leisure-time physical activity (Aim 2) [Срок оценки: Through study completion up to 7 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Roswell Park Cancer Institute — Buffalo

Идентификаторы

NCT: NCT06869447 · I-3969424 · NCI-2025-01035 · I-3969424

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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