A Prospective Study of Patient Centered Outcomes in the Management of Malignant Pleural Effusions
This study will compare various treatment strategies in the management of malignant pleural
effusions with respect to:
1. Primary endpoint: the successful palliation of symptomatic pleural effusions as
assessed by the London Chest Activity of Daily Living Scale (LCADLS)
2. Secondary endpoints:
i) impact of treatment on patient quality of life as assessed by the Functional
Assessment of Chronic Illness Therapy - Palliative patient (FACIT-PAL) questionnaire
ii) Assessment of patient satisfaction with treatment received via Functional
Assessment of Chronic Illness Therapy-Treatment Satisfaction (FACIT-TS) questionnaire
iii)Pleurodesis success rates assessed by 2 and 6-week effusion control rates on CXR
iv) Requirement of further hospitalizations or procedures for the treatment of
recurrent effusions v) Comparison of morbidity and mortality rates for differing
treatment approaches vi) comparison of cost in a Canadian health care setting for
differing treatment approaches
Observational
Observational Model: Case-Only, Time Perspective: Prospective
Gail Darling, MD, FRCS(C)
Principal Investigator
University of Toronto
Canada: Health Canada
04-0233-CE
NCT00188474
August 2004
December 2013
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