Lung Cancer Clinical Trial
Official title:
Comparative Effectiveness of Indwelling Pleural Catheters Versus Thoracoscopic Pleurodesis for Treatment of Malignant Pleural Effusions
Verified date | April 2016 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 445 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Patient Responses to MDASI | M. D. Anderson Symptom Inventory (MDASI) symptoms questionnaire: 19 questions about symptoms rated on a scale of 1-10. | Monthly beginning at pleural effusion treatment | No |
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