Pulmonary Rehabilitation Before Lung Cancer Resection
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|ClinicalTrials.gov Identifier: NCT02887521|
Recruitment Status : Terminated (Poor accrual)
First Posted : September 2, 2016
Results First Posted : June 23, 2020
Last Update Posted : June 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer (NSCLC) Chronic Obstructive Pulmonary Disease (COPD)||Other: education Procedure: rehabilitation Device: pedometer Procedure: surgery||Phase 3|
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.
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Pulmonary Rehabilitation Before Lung Cancer Resection|
|Actual Study Start Date :||March 15, 2017|
|Actual Primary Completion Date :||April 22, 2019|
|Actual Study Completion Date :||October 1, 2019|
Experimental: Pulmonary Rehabilitation (PR)
Patients will receive 10 in-clinic sessions of preoperative Pulmonary Rehabilitation (PR) two weeks prior to surgery. Patients will receive a Participant Manual demonstrating and explaining the rehabilitation process. Patients will also receive a log for recording their efforts and notes for every day until the day of surgery. A video recording of the intervention from start to finish will be provided to all patients. The video recording should be played in all 10 sessions at the registering site. The PR sessions will include breathing awareness, upper and lower extremity exercise, instructions for inspiratory muscle training using the PFlex valve, practice at home and goal setting. Patients undergo surgery and will be followed until 6 months following surgery. Patients complete follow up questionnaires at 3 and 6 months after discharge.
pulmonary rehabilitation participant manual
patients undergo surgery
Active Comparator: Standard of Care
Patients will receive a pedometer to monitor their daily steps and a pamphlet with exercises plus the standard course of care for patients undergoing lung resection surgery. The patients will not be asked to return the pedometer. The local institutional coordinator will go over the use of the pedometer and the exercise materials with the patient. The patients will be asked to keep a log of their pre-operative steps and mail the log to the registering site. Patients undergo surgery and will be followed until 6 months following surgery. Patients complete follow up questionnaires at 3 and 6 months after discharge.
receive a pedometer
receive a pamphlet with exercises plus the standard course of care
patients undergo surgery
- Hospital Length of Stay Assessed With Complete Admission Hospital Records [ Time Frame: Up to 6 months ]
The coordinator at each site will be responsible for sending complete de-identified hospital records from each patient to Dr. Benzo's staff, where a nurse blinded to the study arm will abstract the main outcome (length of stay and postoperative complications).
The primary endpoint will be assessed at Dr. Benzo's office (Mayo Clinic) with the complete admission hospital records in order to extract the length of stay. The records will be mailed from the sites to Johanna Hoult in a pre-stamped envelope.
- Post-operative Pulmonary Complications Assessed by Chart Review [ Time Frame: Up to 6 months ]The following events will be considered postoperative pulmonary complications: pneumonia (new infiltrate + either fever (>38.5 C) and white cell count >11,000 or fever and purulent secretions), severe atelectasis (requiring bronchoscopy), prolonged chest tubes (>6 days), and respiratory failure (intubation or prolonged mechanical ventilation (>24 hours). These outcomes will be obtained by chart review by a nurse trained in the abstraction of the desired outcomes from the medical records and blinded to treatment assignment.
- Quality of Life (QOL) Assessed by Chronic Respiratory Questionnaire [ Time Frame: At baseline and at 6 months ]Chronic Respiratory Questionnaire (CRQ) (four domains: dyspnea, fatigue, emotional function and mastery). This instrument will be the primary tool to assess QoL given that it was specifically designed for COPD. Specifically, the CRQ represents one of the most well known, widely-applied, and psychometrically-sound patient reported outcomes for use in clinical trials involving patients with COPD. Each domain includes 4 to 7 items, with each item graded on 7-point Likert scale; item scores within a domain are summated to provide a total score for each domain. The endpoint value is the 6 month values minus the baseline values. Therefore the endpoint score may range from minus-7 to 7. Higher scores indicate better HRQL. A negative change from baseline to study completion indicates a worsening score.
- Quality of Life (QOL) Assessed by Linear Analog Self-Assessment [ Time Frame: Up to 6 months ]LASA (single-item numerical analogue quality of life Questionnaire) individual QOL domain scores have been validated previously for lung cancer patient populations and for assessment of patient-reported outcomes in similar trials. Survey is based on 6 questions that are scored on a 0-10 scale with 0 being "as bad as it can be" and 10 being "As good as it can be." A negative change in score from baseline indicates a worsening score.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02887521
|United States, Florida|
|Mayo Clinic in Florida|
|Jacksonville, Florida, United States, 32224-9980|
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|United States, Michigan|
|Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Texas|
|Baylor University Medical Center|
|Dallas, Texas, United States, 75246|
|United States, Wisconsin|
|Saint Vincent Hospital Cancer Center Green Bay|
|Green Bay, Wisconsin, United States, 54301|
|London Regional Cancer Program|
|London, Ontario, Canada, N6A 4L6|
|Study Chair:||Robert Benzo, MD, MSc||Mayo Clinic|