Pulmonary Rehabilitation Before Lung Cancer Resection

NCT ID: NCT01682850

Last Updated: 2020-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2019-03-31

Brief Summary

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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).

Detailed Description

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Conditions

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Lung Cancer COPD Chronic Obstructive Lung Disease Emphysema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention

The Intervention Arm will receive 10 sessions of Mindfulness Based Pulmonary Rehabilitation prior to lung surgery

Group Type ACTIVE_COMPARATOR

Mindfulness Based Pulmonary Rehabilitation

Intervention Type BEHAVIORAL

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.

Usual Care

The Usual Care Arm will receive the normal care that a patient with severe COPD having a lung surgery would receive.

Group Type PLACEBO_COMPARATOR

Usual Care

Intervention Type OTHER

Interventions

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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.

Intervention Type BEHAVIORAL

Usual Care

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Roberto P. Benzo

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roberto P Benzo, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Jacksonville, Florida, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

University of Virginia

Charlottesville, Virginia, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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1R01CA163293-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

11-005820

Identifier Type: -

Identifier Source: org_study_id

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