Pleural Catheters Versus Thoracoscopic Pleurodesis
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Lung Cancer |
Behavioral: MDASI Questionnaire |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Comparative Effectiveness of Indwelling Pleural Catheters Versus Thoracoscopic Pleurodesis for Treatment of Malignant Pleural Effusions |
- Quality-Adjusted Survival Times [ Time Frame: 12 Months with follow up until death or recurrence ] [ Designated as safety issue: No ]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.
- Patient Responses to MDASI [ Time Frame: Monthly beginning at pleural effusion treatment ] [ Designated as safety issue: No ]M. D. Anderson Symptom Inventory (MDASI) symptoms questionnaire: 19 questions about symptoms rated on a scale of 1-10.
| Estimated Enrollment: | 345 |
| Study Start Date: | April 2010 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Thoracoscopy Group |
Behavioral: 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 Name: Survey
|
| Indwelling Pleural Catheters |
Behavioral: 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 Name: Survey
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients, 18 years or older, with malignant pleural effusions, suitable for either pleural catheter placement or thoracoscopic pleurodesis.
Inclusion Criteria:
- Patients with MPE who are suitable for either pleural catheter placement or thoracoscopic pleurodesis who subsequently have either procedure performed
- Sufficient mental capacity to answer SF-6D and Borg score questions
- Age 18 or older
- Life expectancy > 2 months
- English or Spanish speaking
Exclusion Criteria:
- Patients undergoing pleurodesis for benign disease (e.g., spontaneous pneumothorax)
- Inability or unwillingness to give informed consent
- Inability to perform phone call follow-up
- Pregnancy
- Previous intrapleural therapy for MPE
- Prior radiation therapy encompassing the entire hemithorax
- Chylous effusions associated with malignant disease
- Bilateral effusions requiring bilateral pleurodesis
Contacts and Locations| Contact: David Ost, MD | 713-792-6238 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: David Ost, MD | |
| Study Chair: | David Ost, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01117740 History of Changes |
| Other Study ID Numbers: | 2010-0103 |
| Study First Received: | April 20, 2010 |
| Last Updated: | April 17, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Malignant Pleural Effusions MPE Lungs Quality of Life M. D. Anderson Symptom Inventory MDASI |
Indwelling Pleural Catheters Thoracoscopic Pleurodesis Symptom burden Pleurodesis efficacy Complications Health care resource utilization |
Additional relevant MeSH terms:
|
Lung Neoplasms Pleural Effusion Pleural Effusion, Malignant Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Pleural Diseases Pleural Neoplasms |
ClinicalTrials.gov processed this record on May 19, 2013