NCT01117740

Brief Summary

The goal of this clinical research study is to compare 2 different methods for treating a pleural effusion. Researchers also want to learn how the treatment you receive effects your quality of life (your ability to do the things you like to do and how happy you feel.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
445

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

April 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 5, 2010

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 11, 2016

Status Verified

April 1, 2016

Enrollment Period

6 years

First QC Date

April 20, 2010

Last Update Submit

April 8, 2016

Conditions

Lung Cancer

Keywords

Malignant Pleural EffusionsMPELungsQuality of LifeM. D. Anderson Symptom InventoryMDASIIndwelling Pleural CathetersThoracoscopic PleurodesisSymptom burdenPleurodesis efficacyComplicationsHealth care resource utilization

Outcome Measures

Primary Outcomes (1)

  • Quality-Adjusted Survival Times

    Quality-adjusted time to death (measured as QALYs) for two patient groups (indwelling pleural catheters and thoracoscopy), calculated using Brazier's SF-6D utility measure described to determine utilities, then integrating utilities over time to arrive at quality-adjusted survival for each patient.

    12 Months with follow up until death or recurrence

Secondary Outcomes (1)

  • Patient Responses to MDASI

    Monthly beginning at pleural effusion treatment

Study Arms (2)

Thoracoscopy Group

Behavioral: MDASI Questionnaire

Indwelling Pleural Catheters

Behavioral: MDASI Questionnaire

Interventions

MDASI QuestionnaireBEHAVIORAL

19 question M. D. Anderson Symptom Inventory (MDASI) before pleural effusion treatment and at each follow-up visit, takes about 5 minutes to complete each time.

Also known as: Survey
Indwelling Pleural CathetersThoracoscopy Group

Eligibility Criteria

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

Patients, 18 years or older, with malignant pleural effusions, suitable for either pleural catheter placement or thoracoscopic pleurodesis.

You may qualify if:

  • Patients with MPE who are suitable for either pleural catheter placement or thoracoscopic pleurodesis who subsequently have either procedure performed
  • Sufficient mental capacity to answer SF-6D and Borg score questions
  • Age 18 or older
  • Life expectancy \> 2 months
  • English or Spanish speaking

You may not qualify if:

  • Patients undergoing pleurodesis for benign disease (e.g., spontaneous pneumothorax)
  • Inability or unwillingness to give informed consent
  • Inability to perform phone call follow-up
  • Pregnancy
  • Previous intrapleural therapy for MPE
  • Prior radiation therapy encompassing the entire hemithorax
  • Chylous effusions associated with malignant disease
  • Bilateral effusions requiring bilateral pleurodesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Ost DE, Jimenez CA, Lei X, Cantor SB, Grosu HB, Lazarus DR, Faiz SA, Bashoura L, Shannon VR, Balachandran D, Noor L, Hashmi YB, Casal RF, Morice RC, Eapen GA. Quality-adjusted survival following treatment of malignant pleural effusions with indwelling pleural catheters. Chest. 2014 Jun;145(6):1347-1356. doi: 10.1378/chest.13-1908.

    PMID: 24480929DERIVED

Related Links

MeSH Terms

Conditions

Lung NeoplasmsPleural Effusion, Malignant

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesPleural NeoplasmsPleural EffusionPleural Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • David Ost, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

April 20, 2010

First Posted

May 5, 2010

Study Start

April 1, 2010

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 11, 2016

Record last verified: 2016-04

Locations

US(1)