Accelerated Pulmonary Rehabilitation in the Preoperative Period

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Vermont
University of Vermont Medical Center
RECRUITING
Burlington
Contact Information
Primary
Olivia J Garrow, MS, RDN
olivia.johnson@uvmhealth.org
802-847-2160
Backup
Sophie Macner
sophie.macner@uvmhealth.org
802-847-2193
Time Frame
Start Date: 2024-01-02
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 20
Treatments
Experimental: Prehab
Sponsors
Leads: University of Vermont

This content was sourced from clinicaltrials.gov