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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA047904 | U.S. NIH Grant/Contract | View source | |
| K23CA106544 | U.S. NIH Grant/Contract | View source | |
| 08-007135 | Other Identifier | Mayo Clinic IRB | |
| NCI-2009-01148 | Registry Identifier | NCI-CTRP | |
| MC0825 | Other Identifier | Mayo Clinic Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 intervention arms.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Receive standard care and educational material on exercise and lifestyle choices of well-being |
|
| Lifestyle intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exercise intervention | Behavioral | life style |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay in hospital and functional status measured at 12 weeks post-operatively | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital re-admission | 12 months | |
| Oxygen requirement | 12 months | |
| Post-operative pulmonary function |
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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:
Presence of moderate to severe lung disease, meeting 1 of the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Roberto P. Benzo, MD, MS | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31618297 | Derived | Perrotta F, Cennamo A, Cerqua FS, Stefanelli F, Bianco A, Musella S, Rispoli M, Salvi R, Meoli I. Effects of a high-intensity pulmonary rehabilitation program on the minute ventilation/carbon dioxide output slope during exercise in a cohort of patients with COPD undergoing lung resection for non-small cell lung cancer. J Bras Pneumol. 2019 Oct 14;45(6):e20180132. doi: 10.1590/1806-3713/e20180132. eCollection 2019. |
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| smoking cessation intervention |
| Behavioral |
Life style |
|
| counseling intervention | Other | life style |
|
| educational intervention | Other | life style |
|
| conventional surgery | Procedure | life style |
|
| pulmonary complications management/prevention | Procedure | life style |
|
| 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 |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D011183 | Postoperative Complications |
| D014029 | Tobacco Use Disorder |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| D018479 | Early Intervention, Educational |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D002662 | Child Health Services |
| D011314 | Preventive Health Services |
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