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This is a study funded by the National Institute of Health. The rationale for the need of this research is the lack of any well proven risk-reducing intervention that may decrease the morbidity of lung cancer resection in patients with COPD or that may improve their quality of life trajectory, a meaningful outcome in the overall disease progression. The proposed intervention is unique as it combines exercise and behavioral interventions that were pilot tested in a randomized single-blinded controlled design in the proposed population and proved feasible and potentially effective. The aim is to test the effect of the proposed rehabilitation on length of stay, pulmonary complications and quality of life trajectory.
Prospectively, 194 patients will be randomized to either ten sessions of preoperative pulmonary rehabilitation (PR) vs. standard care at a number of healthcare centers throughout the United States. This study will be open for 36 months. Randomization will be stratified by three variables: very severe lung function (yes vs. no), prior neo-adjuvant chemotherapy for this operation (yes vs. no) and open thoracotomy vs. video assisted thoracoscopy. The primary and secondary objectives are provided below. Primary Objective: To prospectively determine the effect of 10 sessions of customized preoperative PR on the length of hospital stay in patients that undergo a lung cancer resection and have COPD compared to a matched control group. Hypothesis: Ten sessions of customized preoperative PR will significantly reduce the length of hospital stay. Secondary Objectives: 1. To prospectively determine the effect of 10 sessions of customized preoperative PR on the number of postoperative complications in patients that undergo a lung cancer resection and have COPD compared to a matched control group. * Hypothesis: Ten sessions of customized preoperative PR will significantly reduce the number of postoperative pulmonary complications. 2. To prospectively determine the effect of a 10-session preoperative PR on the trajectory of quality of life at 3 and 6 months after the curative resection compared to a matched control group. * Hypothesis: Ten sessions of customized preoperative PR will significantly and meaningfully (more than the minimal clinically important difference) improve quality of life after surgery compared to a control group. Patients will be followed at 3 and 6 months post-surgery.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Mayo Clinic in Florida
Jacksonville, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Henry Ford Hospital
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Baylor University Medical Center
Dallas, Texas, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States
London Regional Cancer Program
London, Ontario, Canada
Start Date
February 28, 2018
Primary Completion Date
April 22, 2019
Completion Date
September 25, 2019
Last Updated
February 3, 2025
9
ACTUAL participants
education
OTHER
rehabilitation
PROCEDURE
pedometer
DEVICE
education
OTHER
surgery
PROCEDURE
Lead Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
NCT06305754
NCT07477600
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05920356