Pulmonary Rehabilitation Before Lung Cancer Resection
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01682850|
Recruitment Status : Enrolling by invitation
First Posted : September 11, 2012
Last Update Posted : February 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer COPD Chronic Obstructive Lung Disease Emphysema||Behavioral: Mindfulness Based Pulmonary Rehabilitation Other: Usual Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||154 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Pulmonary Rehabilitation Before Lung Cancer Resection|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Active Comparator: Intervention
The Intervention Arm will receive 10 sessions of Mindfulness Based Pulmonary Rehabilitation prior to lung surgery
Behavioral: Mindfulness Based Pulmonary Rehabilitation
Participants in this group will under go 10 sessions of mindfulness based pulmonary rehabilitation prior to surgery. Each session is about 2 hours long and consists of upper /lower extremity training, breathing exercises, and education.
Placebo Comparator: Usual Care
The Usual Care Arm will receive the normal care that a patient with severe COPD having a lung surgery would receive.
Other: Usual Care
- Measure of length of hospital stay post surgical resection of lung cancer in patients that underwent a resection for lung cancer. [ Time Frame: baseline to release from hospital - approx 10 days ]The length of hospital stay will be compared between participants that under went 10 Mindful Rehabilitation Sessions with participants who received the usual care prior to a lung resection.
- Measure post-operative complications in patients that under went 10 session of Mindful Pulmonary Rehabilitation prior to lung resection compared to patients who received usual care prior to a lung resection for lung cancer. [ Time Frame: Post surgerybaseline to release from hospital - approx 10 days ]The study will compare the number of ICU days, ventilation hours, number of days with a chest tube, subsequent pneumonia or respiratory failure in patients that underwent 10 Mindful Pulmonary Rehabilitation sessions prior to a lung resection to patients who received the usual care prior to a lung resection for lung cancer.
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): NCT01682850
|United States, Florida|
|Jacksonville, Florida, United States, 32224|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15232|
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Roberto P Benzo, MD||Mayo Clinic|