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Pulmonary Rehabilitation Before Lung Cancer Resection

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ClinicalTrials.gov Identifier: NCT01682850
Recruitment Status : Unknown
Verified January 2016 by Roberto P. Benzo, Mayo Clinic.
Recruitment status was:  Enrolling by invitation
First Posted : September 11, 2012
Last Update Posted : March 18, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study seeks to study the effectiveness of a short mindfulness based pulmonary rehabilitation program prior to a surgical resection in patients with lung cancer and severe Chronic Obstructive Lung Disease (COPD).

Condition or disease Intervention/treatment
Lung Cancer COPD Chronic Obstructive Lung Disease Emphysema Behavioral: Mindfulness Based Pulmonary Rehabilitation Other: Usual Care

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
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 : August 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is scheduled to undergo a surgery for non small cell lung cancer
  • Moderate to severe COPD
  • Current or ex smoker of ten or more years

Exclusion Criteria:

  • Unable to perform exercise due to active cardiovascular, musculoskeletal or mental problems Poorly motivated to attend the rehabilitation sessions or receive randomization.
Contacts and Locations

Information from the National Library of Medicine

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


Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Washington University
St Louis, Minnesota, 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
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Principal Investigator: Roberto P Benzo, MD Mayo Clinic
More Information

Responsible Party: Roberto P. Benzo, Principle Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01682850     History of Changes
Other Study ID Numbers: 11-005820
1R01CA163293-01 ( U.S. NIH Grant/Contract )
First Posted: September 11, 2012    Key Record Dates
Last Update Posted: March 18, 2016
Last Verified: January 2016

Keywords provided by Roberto P. Benzo, Mayo Clinic:
COPD
Chronic Obstructive Lung Disease
lung cancer
emphysema
Pulmonary Rehabilitation

Additional relevant MeSH terms:
Lung Neoplasms
Lung Diseases
Emphysema
Pulmonary Emphysema
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Respiratory Tract Diseases
Pathologic Processes