Evaluating Quality of Life for Patients With Chronic Obstructive Pulmonary Disease Who Are Undergoing Lung Transplantation

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

TERMINATED

Total Enrollment

419 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2015-09-30

Brief Summary

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Most people undergoing lung transplantation have chronic obstructive pulmonary disease (COPD), a disease in which the lung airways are partly damaged and obstructed, making it difficult to breathe. This study will enroll people with COPD who are undergoing a lung transplant to examine how their quality of life changes after the transplant procedure.

Detailed Description

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Lung transplantation is one treatment option for people with end-stage lung disease. The majority of people undergoing a lung transplant have COPD, and while transplantation can potentially improve survival and quality of life, it may also carry substantial risks, including surgical complications, infections, and pneumonia. The impact of lung transplantation on survival and quality of life has not been extensively studied. In the United States, the United Network for Organ Sharing (UNOS) is the organization that allocates donor lungs to lung recipients. Before 2005, the length of time that a candidate had been on the transplant waiting list was the major determining factor for receiving a donor lung. In mid 2005, the UNOS system changed and began prioritizing candidates on the basis of risk of death prior to lung transplantation and the probability of death within the first year after transplantation. The purpose of this study is to evaluate quality of life factors for lung transplant patients with COPD, both before and after the lung transplant procedure. In addition, quality of life of patients in the new UNOS allocation system will be compared with that of patients in the old UNOS allocation system.

This study will enroll all COPD patients undergoing an evaluation for lung transplantation at the Washington University Medical Center and Barnes-Jewish Hospital in St. Louis, Missouri. Participants will attend study visits at the time of the transplant evaluation and again just prior to listing in the UNOS system. After the transplant, participants will attend study visits at Months 3 and 6 and then once a year for 5 years. During each study visit, participants will complete a computerized interview and health-related questionnaires that will assess quality of life factors, including social life, work life, and home life. Study researchers will also review participants' medical records to collect information on lung function and blood test results.

Conditions

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Pulmonary Disease, Chronic Obstructive Lung Transplantation

Keywords

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COPD Lung Transplant Quality of Life End Stage Lung Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Referred to the adult lung transplant program
* Undergoing evaluation for lung transplantation
* Very severe COPD (Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] class IV) that is predominantly due to emphysema
* Able to read English
* Able to adequately see a computer screen

Exclusion Criteria

* Diagnosis other than COPD
* Inability to read English

Minimum Eligible Age

21 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roger D. Yusen, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine, St. Louis

Locations

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Washington University School of Medicine and Barnes-Jewish Hospital

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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R01HL083067

Identifier Type: NIH

Identifier Source: secondary_id

View Link

564

Identifier Type: -

Identifier Source: org_study_id