Pleural Catheters Versus Thoracoscopic Pleurodesis

April 8, 2016 updated by: M.D. Anderson Cancer Center

Comparative Effectiveness of Indwelling Pleural Catheters Versus Thoracoscopic Pleurodesis for Treatment of Malignant Pleural Effusions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

If you agree to take part in this study, you may be asked to fill out a questionnaire called the MD Anderson Symptom Inventory (MDASI) before your scheduled pleural effusion treatment procedure, 24 hours after your procedure, and then weekly for the next 4 months. During this time, a member of the study staff or a computer system will call you at home on your desired day and time to complete the questionnaire. The MDASI for lung-related symptoms has 22 questions about the possible symptoms caused by the disease, and how the symptoms may affect the activities of your daily life, which you will rate on a scale of 0-10. The MDASI will take about 5 minutes to complete each time.

You will also complete 2 questionnaires called the SF6D Patient Self Assessment and Borg Scale before your scheduled pleural effusion treatment procedure, 2 weeks later, and then 1 time a month for 1 year. These questionnaires are part of your standard of care. There are 7 questions total about how the symptoms may affect the activities of your daily life. If you are not in the clinic, a member of the study staff will call you at home on your desired day and time to complete the questionnaires. The questionnaires should take about 5 minutes total to complete each time.

Your information will be stored in a password-protected database for use in future research related to cancer for up to 5 years after the study is completed.

Before any of your information that is stored in the database can be used for research, the people doing the research must get specific approval from the Institutional Review Board (IRB) of MD Anderson. The IRB is a committee made up of doctors, researchers, and members of the community. The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner. All research done at MD Anderson, including research involving your data from this bank, must first be approved by the IRB.

Your information will be given a code number so that none of your personal identifying information will be directly linked to your information. Only the researcher in charge of the database will have access to the code numbers and be able to link the information in the database back to you. Other researchers who use the database will not be able to link your information or file back to you.

This is an investigational study. Up to 445 participants will be enrolled at MD Anderson.

Study Type

Observational

Enrollment (Actual)

445

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Thoracoscopy Group
Behavioral: MDASI Questionnaire
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.
Other Names:
  • Survey
Indwelling Pleural Catheters
Behavioral: MDASI Questionnaire
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.
Other Names:
  • Survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality-Adjusted Survival Times
Time Frame: 12 Months with follow up until death or recurrence
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Responses to MDASI
Time Frame: Monthly beginning at pleural effusion treatment
M. D. Anderson Symptom Inventory (MDASI) symptoms questionnaire: 19 questions about symptoms rated on a scale of 1-10.
Monthly beginning at pleural effusion treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Study Chair: David Ost, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ACTUAL)

April 1, 2016

Study Completion (ACTUAL)

April 1, 2016

Study Registration Dates

First Submitted

April 20, 2010

First Submitted That Met QC Criteria

May 4, 2010

First Posted (ESTIMATE)

May 5, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 11, 2016

Last Update Submitted That Met QC Criteria

April 8, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-0103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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