Study Results
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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COMPLETED
445 participants
OBSERVATIONAL
2010-04-30
2016-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Thoracoscopy Group
MDASI Questionnaire
19 question M. D. Anderson Symptom Inventory (MDASI) before pleural effusion treatment and at each follow-up visit, takes about 5 minutes to complete each time.
Indwelling Pleural Catheters
MDASI Questionnaire
19 question M. D. Anderson Symptom Inventory (MDASI) before pleural effusion treatment and at each follow-up visit, takes about 5 minutes to complete each time.
Interventions
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MDASI Questionnaire
19 question M. D. Anderson Symptom Inventory (MDASI) before pleural effusion treatment and at each follow-up visit, takes about 5 minutes to complete each time.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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David Ost, MD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Locations
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University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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Ost DE, Jimenez CA, Lei X, Cantor SB, Grosu HB, Lazarus DR, Faiz SA, Bashoura L, Shannon VR, Balachandran D, Noor L, Hashmi YB, Casal RF, Morice RC, Eapen GA. Quality-adjusted survival following treatment of malignant pleural effusions with indwelling pleural catheters. Chest. 2014 Jun;145(6):1347-1356. doi: 10.1378/chest.13-1908.
Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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2010-0103
Identifier Type: -
Identifier Source: org_study_id
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