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Pulmonary Rehabilitation Before Lung Cancer Resection

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roberto P. Benzo, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01682850
First received: September 4, 2012
Last updated: September 10, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention
Lung Cancer
COPD
Chronic Obstructive Lung Disease
Emphysema
 Behavioral: Mindfulness Based Pulmonary Rehabilitation
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Pulmonary Rehabilitation Before Lung Cancer Resection

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 154
Study Start Date: September 2012
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682850

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

No publications provided

Responsible Party: Roberto P. Benzo, Principle Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01682850     History of Changes
Other Study ID Numbers: 11-005820, 1R01CA163293-01
Study First Received: September 4, 2012
Last Updated: September 10, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Mayo Clinic:
COPD
Chronic Obstructive Lung Disease
lung cancer
emphysema
Pulmonary Rehabilitation

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

ClinicalTrials.gov processed this record on May 19, 2013