Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00188474
Status:
COMPLETED
Last Update Posted:
2017-05-04
First Post:
2005-09-12
Brief Title:
A Quality of Life Study re Management of Malignant Pleural Effusions
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Prospective Study of Patient Centered Outcomes in the Management of Malignant Pleural Effusions
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients perspective is not available
Detailed Description:
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 iiiPleurodesis 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
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 iiiPleurodesis 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None