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Accelerated Pulmonary Rehabilitation in the Preoperative Period

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Investigators will also administer the General Anxiety Disorder-7 (GAD-7) questionnaire to assess for anxiety."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a lung exercise program before lung cancer treatment is safe and practical. It is for adults who smoke and have a lung spot that is likely to be cancer. Everyone will join the program and be offered help to quit smoking.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have a lung spot that lung cancer doctors think is very likely to be cancer, based on tests and risk factors.
  • Be able to receive treatment.
  • Currently smoke at least 5 cigarettes a day.
  • Be willing to try to quit smoking during the program.
  • Be willing to use nicotine replacement and varenicline, medicines that help people quit smoking.
  • Be able to attend the lung exercise program at UVMMC: two back-to-back, one-hour sessions each day, for 16 sessions over 8 days during treatment.
  • Be willing and able to understand the study and agree to join, as judged by the study or treatment doctors.

Who can't join

  • Have a health problem that makes group exercise unsafe, as judged by the doctors. Examples include unstable heart or blood vessel disease, muscle or bone problems that prevent exercise, or serious mental health, memory, or thinking problems.
  • Be unable to attend the lung exercise program regularly during treatment.
  • Be pregnant, based on what you report.
  • Be taking part in another clinical trial now or recently that the study doctor thinks could affect this study's results.
  • Have any other condition that the doctors think could put your safety or the study's results at risk.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

VT