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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
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Malignant Pleural Effusions Behavioral: 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:

  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 Design
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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
Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
    Behavioral: LCADLS, FACIT-PAL, FACIT-TS questionnaires
    LCADLS, FACIT-PAL, FACIT-TS questionnaires

Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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