A Quality of Life Study re Management of Malignant Pleural Effusions
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ClinicalTrials.gov Identifier: NCT00188474 |
Recruitment Status
:
Completed
First Posted
: September 16, 2005
Last Update Posted
: May 4, 2017
|
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Condition or disease | Intervention/treatment |
---|---|
Malignant Pleural Effusions | Behavioral: LCADLS, FACIT-PAL, FACIT-TS questionnaires |
This study will compare various treatment strategies in the management of malignant pleural effusions with respect to:
- Primary endpoint: the successful palliation of symptomatic pleural effusions as assessed by the London Chest Activity of Daily Living Scale (LCADLS)
-
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
Study Type : | Observational |
Actual Enrollment : | 149 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | A Prospective Study of Patient Centered Outcomes in the Management of Malignant Pleural Effusions |
Study Start Date : | August 2004 |
Actual Primary Completion Date : | November 2013 |
Actual Study Completion Date : | November 2013 |
-
Behavioral: LCADLS, FACIT-PAL, FACIT-TS questionnaires
- the successful palliation of symptomatic pleural effusions as assessed by the London Chest Activity of Daily Living Scale (LCADLS) [ Time Frame: discharge, 2 wks and 6 wks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- symptomatic pleural effusion
- history of malignant disease
- age greater that 18 years
- consent to participate in study
Exclusion Criteria:
- significant ipsilateral endobronchial disease
- prior ipsilateral, intra-pleural therapy, as defined by: prior chest tube placement for effusion, prior attempt at chemical/surgical pleurodesis, prior surgical pleurectomy
- active pulmonary or pleural infection
- granulocytes < 1500/mm3, platelets < 50,000/mm3
- systemic chemotherapy within 2 weeks
- allergy to talc

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00188474
Canada, Ontario | |
University Health Network | |
Toronto, Ontario, Canada, M5G 2C4 | |
St. Joseph's Hospital | |
Toronto, Ontario, Canada |
Principal Investigator: | Gail Darling, MD, FRCS(C) | University of Toronto |
Responsible Party: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00188474 History of Changes |
Other Study ID Numbers: |
04-0233-CE |
First Posted: | September 16, 2005 Key Record Dates |
Last Update Posted: | May 4, 2017 |
Last Verified: | May 2017 |
Additional relevant MeSH terms:
Pleural Effusion Pleural Effusion, Malignant Pleural Diseases Respiratory Tract Diseases Pleural Neoplasms |
Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |