Lung Rehabilitation in Treating Patients With Chronic Obstructive Pulmonary Disease Who Are Undergoing Surgery for Lung Cancer

Study Overview
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Brief Summary
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RATIONALE: Exercise may help improve lung function and lessen complications of surgery in patients with chronic obstructive pulmonary disease who are undergoing surgery for lung cancer. It is not yet known whether lung rehabilitation is more effective than standard therapy in improving lung function in patients with chronic obstructive pulmonary disease who are undergoing surgery for lung cancer. PURPOSE: This randomized clinical trial is studying lung rehabilitation to see how well it works compared to standard therapy in treating patients with chronic obstructive pulmonary disease who are undergoing surgery for lung cancer.

Detailed Description
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OBJECTIVES: Primary Compare the impact of preoperative pulmonary rehabilitation (including upper and lower extremity resistance training) vs usual care in patients with lung cancer and moderate to severe chronic obstructive pulmonary disease who require lung resection for lung cancer. Compare the impact of this study intervention vs usual care on functional status after surgery. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 intervention arms. Arm I: Patients undergo pulmonary rehabilitation (including daily upper and lower extremity resistance training, education, and smoking cessation counseling) twice a day for 5 days prior to surgical resection. Beginning 2-3days after surgery, patients undergo pulmonary rehabilitation once a day until discharge from the hospital. Arm II: Patients receive usual care (education and smoking cessation counseling alone) twice a day for 5 days prior to surgical resection. Following surgery, patients will receive usual care once a day until discharge from the hospital. Days of hospitalization, ICU admissions, postoperative complications (i.e., pneumonia, mechanical ventilation > 48 hours, or atelectasis requiring bronchoscopy) and spirometry and imaging studies will be evaluated after surgery. After completion of study intervention, patients are followed at 4-6 weeks, at 12 weeks, and at 6 months. PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.

Official Title
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A Randomized Trial of Pulmonary Rehabilitation in Patients With Moderate to Severe COPD Who Require Lung Resection for Lung Cancer

Conditions
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Lung Cancer, Perioperative/Postoperative Complications, Pulmonary Complications, Tobacco Use Disorder

Intervention / Treatment
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* Behavioral: exercise intervention
* Behavioral: smoking cessation intervention
* Other: counseling intervention
* Other: educational intervention
* Procedure: conventional surgery
* Procedure: pulmonary complications management/prevention


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of lung cancer Scheduled to undergo any thoracotomy for lung cancer resection (including wedge) or VATS lobectomy or pneumonectomy for lung resection Diagnosis of COPD, meeting the following criteria: FEV_1/FVC < 0.71 Smoking history ≥ 10 pack/years Presence of moderate to severe lung disease, meeting 1 of the following: FEV_1 ≤ 60% predicted* FEV_1< 80% predicted AND significant shortness of breath defined by a score of 2 or higher in the Medical Research Council Dyspnea Score NOTE: *Patients with an FEV1 < 60% predicted (most severe) and scheduled to undergo VATS segmentectomy or wedge resection will also be included. PATIENT CHARACTERISTICS: Able to physically utilize exercise equipment as part of rehabilitation program No poor motivation or likely not to participate fully in PR program No recent history (within the past 3 months) of a clinically-significant myocardial infarction, unstable angina, serious cardiac arrhythmia, or other serious medical condition which the attending physician performing the preoperative evaluation deems incompatible with participation in the study PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Receive standard care and educational material on exercise and lifestyle choices of well-being | Behavioral: exercise intervention<br>* life style<br>Behavioral: smoking cessation intervention<br>* Life style<br>Other: counseling intervention<br>* life style<br>Other: educational intervention<br>* life style<br>Procedure: conventional surgery<br>* life style<br>Procedure: pulmonary complications management/prevention<br>* life style<br>|
| Experimental: Lifestyle intervention<br> | Behavioral: exercise intervention<br>* life style<br>Behavioral: smoking cessation intervention<br>* Life style<br>Other: counseling intervention<br>* life style<br>Other: educational intervention<br>* life style<br>Procedure: conventional surgery<br>* life style<br>Procedure: pulmonary complications management/prevention<br>* life style<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in hospital and functional status measured at 12 weeks post-operatively |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital re-admission |  | 12 months | 
| Oxygen requirement |  | 12 months | 
| Post-operative pulmonary function |  | 12 months | 
| Respiratory care interventions |  | 12 months | 
| Number and percentage of patients with postoperative complications (defined as pneumonia, mechanical ventilation of more than 2 days, or atelectasis requiring a bronchoscopy) |  | 12 months | 
| Measured physical activity at 6 months |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary complications, perioperative/postoperative complications, tobacco use disorder, non-small cell lung cancer, small cell lung cancer