A Quality of Life Study re Management of Malignant Pleural Effusions
| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | June 7, 2012 | ||||
| Start Date ICMJE | August 2004 | ||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00188474 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Quality of Life Study re Management of Malignant Pleural Effusions | ||||
| Official Title ICMJE | A Prospective Study of Patient Centered Outcomes in the Management of Malignant Pleural Effusions | ||||
| Brief Summary | There is much data in the literature regarding optimal treatment approaches for malignant pleural effusions as assessed by patient outcomes. However, data on quality of life and satisfaction with treatment from the patient's perspective is not available. |
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| Detailed Description | This study will compare various treatment strategies in the management of malignant pleural effusions with respect to:
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with malignant pleural effusions |
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| Condition ICMJE | Malignant Pleural Effusions | ||||
| Intervention ICMJE | Behavioral: LCADLS, FACIT-PAL, FACIT-TS questionnaires
LCADLS, FACIT-PAL, FACIT-TS questionnaires |
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| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | December 2013 | ||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00188474 | ||||
| Other Study ID Numbers ICMJE | 04-0233-CE | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. Gail Darling, University Health Network | ||||
| Study Sponsor ICMJE | University Health Network, Toronto | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Health Network, Toronto | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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