Pleural Catheters Versus Thoracoscopic Pleurodesis



Status:Completed
Conditions:Lung Cancer, Cancer, Pulmonary
Therapuetic Areas:Oncology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:April 2010
End Date:April 2016

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Comparative Effectiveness of Indwelling Pleural Catheters Versus Thoracoscopic Pleurodesis for Treatment of Malignant Pleural Effusions

The goal of this clinical research study is to compare 2 different methods for treating a
pleural effusion. Researchers also want to learn how the treatment you receive effects your
quality of life (your ability to do the things you like to do and how happy you feel.

If you agree to take part in this study, you may be asked to fill out a questionnaire called
the MD Anderson Symptom Inventory (MDASI) before your scheduled pleural effusion treatment
procedure, 24 hours after your procedure, and then weekly for the next 4 months. During this
time, a member of the study staff or a computer system will call you at home on your desired
day and time to complete the questionnaire. The MDASI for lung-related symptoms has 22
questions about the possible symptoms caused by the disease, and how the symptoms may affect
the activities of your daily life, which you will rate on a scale of 0-10. The MDASI will
take about 5 minutes to complete each time.

You will also complete 2 questionnaires called the SF6D Patient Self Assessment and Borg
Scale before your scheduled pleural effusion treatment procedure, 2 weeks later, and then 1
time a month for 1 year. These questionnaires are part of your standard of care. There are 7
questions total about how the symptoms may affect the activities of your daily life. If you
are not in the clinic, a member of the study staff will call you at home on your desired day
and time to complete the questionnaires. The questionnaires should take about 5 minutes
total to complete each time.

Your information will be stored in a password-protected database for use in future research
related to cancer for up to 5 years after the study is completed.

Before any of your information that is stored in the database can be used for research, the
people doing the research must get specific approval from the Institutional Review Board
(IRB) of MD Anderson. The IRB is a committee made up of doctors, researchers, and members of
the community. The IRB is responsible for protecting the participants involved in research
studies and making sure all research is done in a safe and ethical manner. All research done
at MD Anderson, including research involving your data from this bank, must first be
approved by the IRB.

Your information will be given a code number so that none of your personal identifying
information will be directly linked to your information. Only the researcher in charge of
the database will have access to the code numbers and be able to link the information in the
database back to you. Other researchers who use the database will not be able to link your
information or file back to you.

This is an investigational study. Up to 445 participants will be enrolled at MD Anderson.

Inclusion Criteria:

1. Patients with MPE who are suitable for either pleural catheter placement or
thoracoscopic pleurodesis who subsequently have either procedure performed

2. Sufficient mental capacity to answer SF-6D and Borg score questions

3. Age 18 or older

4. Life expectancy > 2 months

5. English or Spanish speaking

Exclusion Criteria:

1. Patients undergoing pleurodesis for benign disease (e.g., spontaneous pneumothorax)

2. Inability or unwillingness to give informed consent

3. Inability to perform phone call follow-up

4. Pregnancy

5. Previous intrapleural therapy for MPE

6. Prior radiation therapy encompassing the entire hemithorax

7. Chylous effusions associated with malignant disease

8. Bilateral effusions requiring bilateral pleurodesis
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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mi
from
Houston, TX
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