A Quality of Life Study re Management of Malignant Pleural Effusions

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT00188474

First received: September 12, 2005

Last updated: July 29, 2016

Last verified: July 2016

History of Changes

Purpose

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.

Condition	Intervention
Malignant Pleural Effusions	Behavioral: LCADLS, FACIT-PAL, FACIT-TS questionnaires


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	A Prospective Study of Patient Centered Outcomes in the Management of Malignant Pleural Effusions

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]


Enrollment:	149
Study Start Date:	August 2004
Study Completion Date:	November 2013
Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Intervention Details:

LCADLS, FACIT-PAL, FACIT-TS questionnaires

Detailed Description:

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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with malignant pleural effusions

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00188474

Locations


Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2C4
St. Joseph's Hospital
Toronto, Ontario, Canada

Sponsors and Collaborators

University Health Network, Toronto

Investigators


Principal Investigator:	Gail Darling, MD, FRCS(C)	University of Toronto

More Information


Responsible Party:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00188474 History of Changes
Other Study ID Numbers:	04-0233-CE
Study First Received:	September 12, 2005
Last Updated:	July 29, 2016
Health Authority:	Canada: Health Canada

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

ClinicalTrials.gov processed this record on September 30, 2016

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