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

September 12, 2005
June 7, 2012
August 2004
September 2013   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00188474 on ClinicalTrials.gov Archive Site
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A Quality of Life Study re Management of Malignant Pleural Effusions
A Prospective Study of Patient Centered Outcomes in the Management of Malignant Pleural Effusions

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.

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

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Patients with malignant pleural effusions

Malignant Pleural Effusions
Behavioral: LCADLS, FACIT-PAL, FACIT-TS questionnaires
LCADLS, FACIT-PAL, FACIT-TS questionnaires
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Susan J Walker, RN, MScN-ACNP 416-340-4038 susan.walker@uhn.on.ca
Canada
 
NCT00188474
04-0233-CE
No
Dr. Gail Darling, University Health Network
University Health Network, Toronto
Not Provided
Principal Investigator: Gail Darling, MD, FRCS(C) University of Toronto
University Health Network, Toronto
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP