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Pleural Catheters Versus Thoracoscopic Pleurodesis

2014-08-27 03:13:54 | BioPortfolio

Summary

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 received affects quality of life (ability to do the things patients like to do and how happy patient feels).

Description

If you agree to take part in this study, you will fill out a questionnaire called the M. D. Anderson Symptom Inventory (MDASI) before your scheduled pleural effusion treatment procedure and again each time you return to the clinic for a follow-up visit. The MDASI has 19 questions about the possible symptoms caused by the disease, which you will rate on a scale of 1-10. The MDASI will take about 5 minutes to complete each time.

Follow-Up Phone Calls:

After you have completed your final follow-up treatment visit, a computer system will call you at home 1 time each month and ask you the same questions that you answered on the MDASI at your clinic visits. The phone call should last about 5 minutes each time.

Length of Study:

You will continue to complete the MDASI in the clinic for as long as you have follow-up treatments. You will continue to complete the MDASI follow-up phone calls for the rest of your life.

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 M. D. 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 M. D. 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 245 participants will be enrolled at M. D. Anderson.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Conditions

Lung Cancer

Intervention

MDASI Questionnaire

Location

UT MD Anderson Cancer Center
Houston
Texas
United States
77030

Status

Recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:54-0400

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