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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01749 | Registry Identifier | NCI CTRP |
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The goal of this clinical research study is to see if pulmonary rehabilitation can improve patients' lung function, which would increase their chances of becoming eligible for surgery. The health of pulmonary rehabilitation participants after surgery will also be examined.
Pulmonary rehabilitation is a process that is designed to improve patients' lung function, muscular conditioning, exercise performance, and overall quality of life.
Study activities include exercise training, patient and family education, and psychosocial and behavioral counseling provided by a healthcare team.
Rehabilitation plans will vary patient by patient based on the results of the following tests:
Study Visits:
If you choose to take part in this study, you will have 3-4 weeks of pulmonary rehabilitation. During the 3-4 week period, you will have 9-12 study visits that will last about 90 minutes each. The following tests and procedures will be performed:
6-Minute Walk Test:
To perform the 6-minute walk test, you will walk as far as possible around cones on a flat indoor course that is about 40 yards long. You will walk at your own pace and can take breaks at any time. After 6 minutes, the study staff will check the total distance you have walked. Your vital signs (blood pressure, heart rate, temperature, and breathing rate) will be measured before and after the walk. Your oxygen saturation levels will be monitored throughout the test. You will wear a small clip on your finger that will send the oxygen saturation data to a small computer.
Oxygen Consumption Test:
An oxygen consumption study will help the doctor determine how well your heart and lungs work while you exercise. You will be asked to pedal on a bicycle that does not move, while wearing a mouthpiece to measure the amount of oxygen you take in. Wires will be placed on your chest to monitor your heart activity, and a blood pressure cuff will be placed on your arm to monitor your blood pressure.
The amount of exercise you can do will be measured by increasing the resistance you pedal against. You should continue pedaling until you become short of breath or too tired to keep going. You may stop exercising at any time if you become very uncomfortable or experience dizziness, chest pains, and/or shortness of breath.
During or after the oxygen consumption test, blood (about 2 teaspoons) may be drawn to measure the amount of oxygen in your blood.
If you live outside of the Houston area, you will be referred to a pulmonary rehabilitation program in your local area. Any records from the outside pulmonary rehabilitation facility will be given to the study staff after the study is completed. You will have your follow-up visits (described below) at M. D. Anderson.
Follow-up Visits:
Your health status will be checked at 1 and 3 months after your last study visit if you do not have surgery, or 1 and 3 months after your surgery. At these follow-up visits, the following tests and procedures will be performed:
Long-term Follow-up:
The research staff may contact you by phone regarding your health status. Patients who have lung surgery may be contacted by phone or have their medical records reviewed during the course of 30 days after surgery or during hospitalization for surgery (hospitalization may last more than 30 days).
This is an investigational study. Using pulmonary rehabilitation to try to improve patients' lung function is considered experimental. At this time, it is being done in research only. Up to 75 patients will take part in this study. All will be enrolled at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary Rehabilitation | Experimental | Pulmonary Rehabilitation - Rehabilitation treatment given over about 3-4 weeks. Questionnaire regarding quality-of-life that lasts about 30 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Other | Questionnaire regarding quality-of-life that lasts about 30 minutes. |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment Success (conversion from ineligible to eligible status for lung resection following Pulmonary rehabilitation (PR)) | Baseline and post treatment (following 3-4 weeks of PR) |
| Measure | Description | Time Frame |
|---|---|---|
| Examine health of pulmonary rehabilitation participants after surgery. | 2 Years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vickie Shannon, BS,MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Pulmonary Rehabilitation | Behavioral | Rehabilitation treatment given over about 3-4 weeks. |
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |