A Quality of Life Study re Management of Malignant Pleural Effusions

This study is currently recruiting participants.
Verified June 2012 by University Health Network, Toronto
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188474
First received: September 12, 2005
Last updated: June 7, 2012
Last verified: June 2012
  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:

Estimated Enrollment: 100
Study Start Date: August 2004
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: LCADLS, FACIT-PAL, FACIT-TS questionnaires
    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

  Eligibility

Ages Eligible for Study:   18 Years and older
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00188474

Contacts
Contact: Susan J Walker, RN, MScN-ACNP 416-340-4038 susan.walker@uhn.on.ca

Locations
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Susan J Walker, RN, MScN-ACNP    416-340-4038    susan.walker@uhn.on.ca   
St. Joseph's Hospital Terminated
Toronto, Ontario, Canada
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Gail Darling, MD, FRCS(C) University of Toronto
  More Information

No publications provided

Responsible Party: Dr. Gail Darling, University Health Network
ClinicalTrials.gov Identifier: NCT00188474     History of Changes
Other Study ID Numbers: 04-0233-CE
Study First Received: September 12, 2005
Last Updated: June 7, 2012
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 April 15, 2014