NCT00188474

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2004

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

9.3 years

First QC Date

September 12, 2005

Last Update Submit

May 3, 2017

Conditions

Malignant Pleural Effusions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

LCADLS, FACIT-PAL, FACIT-TS questionnairesBEHAVIORAL

LCADLS, FACIT-PAL, FACIT-TS questionnaires

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with malignant pleural effusions

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

St. Joseph's Hospital

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Pleural Effusion, Malignant

Condition Hierarchy (Ancestors)

Pleural NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsPleural EffusionPleural DiseasesRespiratory Tract Diseases

Study Officials

  • Gail Darling, MD, FRCS(C)

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

August 1, 2004

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

May 4, 2017

Record last verified: 2017-05

Locations

CA(2)