Trial record 13 of 458 for:
"tobacco use disorder"
Lung Rehabilitation in Treating Patients With Chronic Obstructive Pulmonary Disease Who Are Undergoing Surgery for Lung Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Mayo Clinic
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00363428
First received: August 10, 2006
Last updated: May 22, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Lung Cancer Perioperative/Postoperative Complications Pulmonary Complications Tobacco Use Disorder |
Behavioral: exercise intervention Behavioral: smoking cessation intervention Other: counseling intervention Other: educational intervention Procedure: conventional surgery Procedure: pulmonary complications management/prevention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | A Randomized Trial of Pulmonary Rehabilitation in Patients With Moderate to Severe COPD Who Require Lung Resection for Lung Cancer |
Resource links provided by NLM:
MedlinePlus related topics:
COPD (Chronic Obstructive Pulmonary Disease)
Cancer
Exercise and Physical Fitness
Lung Cancer
Quitting Smoking
Rehabilitation
Smoking
U.S. FDA Resources
Further study details as provided by Mayo Clinic:
Primary Outcome Measures:
- Length of stay in hospital and functional status measured at 12 weeks post-operatively [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Hospital re-admission [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Oxygen requirement [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Post-operative pulmonary function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Respiratory care interventions [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Number and percentage of patients with postoperative complications (defined as pneumonia, mechanical ventilation of more than 2 days, or atelectasis requiring a bronchoscopy) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Measured physical activity at 6 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 90 |
| Study Start Date: | August 2006 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Control
Receive standard care and educational material on exercise and lifestyle choices of well-being
|
Behavioral: exercise intervention
life style
Behavioral: smoking cessation intervention
Life style
Other: counseling intervention
life style
Other: educational intervention
life style
Procedure: conventional surgery
life style
Procedure: pulmonary complications management/prevention
life style
|
| Experimental: Lifestyle intervention |
Behavioral: exercise intervention
life style
Behavioral: smoking cessation intervention
Life style
Other: counseling intervention
life style
Other: educational intervention
life style
Procedure: conventional surgery
life style
Procedure: pulmonary complications management/prevention
life style
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Roberto P. Benzo, M.D., Mayo Clinic Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00363428 History of Changes |
| Other Study ID Numbers: | CDR0000491312, P30CA047904, K23CA106544, 08-007135, NCI-2009-01148, MC0825 |
| Study First Received: | August 10, 2006 |
| Last Updated: | May 22, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Mayo Clinic:
|
pulmonary complications perioperative/postoperative complications tobacco use disorder non-small cell lung cancer small cell lung cancer |
Additional relevant MeSH terms:
|
Tobacco Use Disorder Lung Diseases Pulmonary Disease, Chronic Obstructive Lung Neoplasms Postoperative Complications Lung Diseases, Obstructive Respiratory Tract Diseases |
Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Pathologic Processes Substance-Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013