Comparative Effectiveness of Indwelling Pleural Catheters Versus Thoracoscopic Pleurodesis for Treatment of Malignant Pleural Effusions
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.
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 345 participants will be enrolled at MD Anderson.
Observational Model: Case-Only, Time Perspective: Prospective
Quality-Adjusted Survival Times
Quality-adjusted time to death (measured as QALYs) for two patient groups (indwelling pleural catheters and thoracoscopy), calculated using Brazier's SF-6D utility measure described to determine utilities, then integrating utilities over time to arrive at quality-adjusted survival for each patient.
12 Months with follow up until death or recurrence
David Ost, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
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