Pulmonary Rehabilitation Before Lung Cancer Resection

January 3, 2020 updated by: Roberto P. Benzo, Mayo Clinic
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline to release from hospital - approx 10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Post surgerybaseline to release from hospital - approx 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Roberto P Benzo, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2013

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

September 4, 2012

First Submitted That Met QC Criteria

September 10, 2012

First Posted (Estimate)

September 11, 2012

Study Record Updates

Last Update Posted (Actual)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 3, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-005820
  • 1R01CA163293-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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