NCT02887521

Pulmonary Rehabilitation Before Lung Cancer Resection

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Non-small Cell Lung Cancer (NSCLC)
• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
OTHER	education	pulmonary rehabilitation participant manual
PROCEDURE	rehabilitation	pulmonary rehabilitation
DEVICE	pedometer	receive a pedometer
OTHER	education	receive a pamphlet with exercises plus the standard course of care
PROCEDURE	surgery	patients undergo surgery

Timeline

• Start date: 2018-02-28
• Primary completion: 2019-04-22
• Completion: 2019-09-25
• First posted: 2016-09-02
• Last updated: 2025-02-03
• Results posted: 2020-06-23

Locations

7 sites across 2 countries: United States, Canada