NCT06432972 Accelerated Pulmonary Rehabilitation in the Preoperative Period

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 20 participants in total. It began in 2024-01-02 with a primary completion date of 2026-06-30.

Brief Summary

This proposed project will be a single arm, non-masked study. Participants who are actively smoking with a diagnosis of a new lung nodule, either confirmed or suspicious for lung cancer, with a plan for lung cancer treatment with or without surgical resection will be recruited from the University of Vermont Medical Center (UVMMC)pulmonary, cardiothoracic surgery, and Lung Multidisciplinary Clinic (LMDC). All patients will be enrolled in prehab and offered smoking cessation therapy. The acceptability and feasibility of this intervention will be measured by percent enrollment in study, attendance, barriers to completion, and monitoring of adverse events. The effect of prehab will be measured by traditional metrics, including fitness, respiratory symptoms, and depression scale. Research outcomes will be measured by smoking habits, anxiety, and surgical complications. Investigators estimate that 20 participants over a two-year period will be sufficient to measure the safety and feasibility of this study. Investigators aim to enroll, on average, 2 participants per month in order to complete this study in a timely fashion. Participants will be enrolled in prehab on a rolling basis, as to not delay surgical timeline.

Eligibility Criteria

Inclusion Criteria: * Age 18 years or older * Lung nodule that is deemed highly suspicious for lung cancer based on: nodule characteristics, risk factors, CT-PET avidity, previous biopsy results, and assessment by physicians specializing in lung cancers * Eligible for treatment * Current cigarette smoking ≥5 cigarettes per day * Willing to attempt smoking cessation during prehab period * Willing to take nicotine replacement therapy (NRT) and varenicline * Able to attend PR at UVMMC for 2, one-hour sequential sessions for a total of 16 sessions over 8 days during treatment * Willing and able to provide informed consent; ability determined by study physician and/or LMDC treatment physicians Exclusion Criteria: * Unable to safely participate in PR due to unstable cardiac disease, unstable peripheral vascular disease, musculoskeletal disease that would prevent exercise, significant psychiatric or neurocognitive disease that would limit ability to exercise safely in a group setting as determined by the study physician and/or treatment physicians * Inability to consistently attend PR during treatment * Pregnancy, per patient self-report * Active or recent participation in another clinical trial that, in the opinion of the investigator would impact outcomes measured in this study * Any other condition in the opinion of the investigator/study physician and or treatment physicians that would jeopardize patient safety or integrity of research results

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