A Quality of Life Study re Management of Malignant Pleural Effusions

Completed

• Conditions: Malignant Pleural Effusions

• Registration Number: NCT00188474
• Lead Sponsor: University Health Network, Toronto

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.

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 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 Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

• symptomatic pleural effusion
• history of malignant disease
• age greater that 18 years
• consent to participate in study

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the successful palliation of symptomatic pleural effusions as assessed by the London Chest Activity of Daily Living Scale (LCADLS)	discharge, 2 wks and 6 wks

Trial Locations

Locations (2)

St. Joseph's Hospital; 🇨🇦 Toronto, Ontario, Canada

University Health Network; 🇨🇦 Toronto, Ontario, Canada