Clinical trial NCT00675376: Evaluating Quality of Life for Patients With Chronic Obstructive Pulmonary Disease Who Are Undergoing Lung Transplantation
Official title: Lung Transplant for COPD: Outcomes/Technology
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pulmonary Disease, Chronic Obstructive
Lung Transplantation
Keywords: COPD
Lung Transplant
Quality of Life
End Stage Lung Disease
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2008-05-09
Enrollment: 419
Sex: ALL
Minimum age (years): 21
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All study participants will undergo evaluation in the lung transplant clinic at Washington University Medical Center and Barnes-Jewish Hospital. They must have the diagnosis of COPD predominantly due to emphysema.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of the effectiveness of lung transplantation in patients with COPD in the new donor lung allocation system
timeFrame: Measured throughout the study
Secondary outcomes:
measure: Comparison of the effects of lung transplantation on the quality of life of patients with COPD in the new donor lung allocation system versus the old donor lung allocation system
timeFrame: Measured throughout the study
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine and Barnes-Jewish Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine, St. Louis
name: Roger D. Yusen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: