RECRUITING

Accelerated Pulmonary Rehabilitation in the Preoperative Period

Conditions

Chronic Obstructive Pulmonary Disease Lung Cancer Pulmonary Rehab

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Accelerated Pulmonary Rehabilitation in the Preoperative Period

Quick Facts

Study Start:2024-01-02

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06432972

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 in a 2-week time frame * Willing and able to provide informed consent; ability determined by study physician and/or LMDC treatment physicians	* 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 over a 2-week period * 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

Inclusion Criteria

Exclusion 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 in a 2-week time frame
* Willing and able to provide informed consent; ability determined by study physician and/or LMDC treatment physicians

* 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 over a 2-week period
* 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

Contacts and Locations

Study Contact

Olivia J Garrow, MS, RDN

CONTACT

802-847-2160

olivia.johnson@uvmhealth.org

Sophie Macner

CONTACT

802-847-2193

sophie.macner@uvmhealth.org

Study Locations (Sites)

University of Vermont Medical Center

Burlington, Vermont, 05401

United States

Collaborators and Investigators

Sponsor: University of Vermont

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 Registration Dates

Study Start Date2024-01-02

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-01-02

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

Pulmonary Rehab

Additional Relevant MeSH Terms

Chronic Obstructive Pulmonary Disease
Lung Cancer