Pleural Catheters Versus Thoracoscopic Pleurodesis

This study is currently recruiting participants.
Verified February 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01117740
First received: April 20, 2010
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Lung Cancer
Behavioral: MDASI Questionnaire

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparative Effectiveness of Indwelling Pleural Catheters Versus Thoracoscopic Pleurodesis for Treatment of Malignant Pleural Effusions

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Quality-Adjusted Survival Times [ Time Frame: 12 Months with follow up until death or recurrence ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Patient Responses to MDASI [ Time Frame: Monthly beginning at pleural effusion treatment ] [ Designated as safety issue: No ]
    M. D. Anderson Symptom Inventory (MDASI) symptoms questionnaire: 19 questions about symptoms rated on a scale of 1-10.


Estimated Enrollment: 445
Study Start Date: April 2010
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: Survey

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.

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01117740

Contacts
Contact: David Ost, MD 713-792-6238

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: David Ost, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: David Ost, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01117740     History of Changes
Other Study ID Numbers: 2010-0103
Study First Received: April 20, 2010
Last Updated: February 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Malignant Pleural Effusions
MPE
Lungs
Quality of Life
M. D. Anderson Symptom Inventory
MDASI
Indwelling Pleural Catheters
Thoracoscopic Pleurodesis
Symptom burden
Pleurodesis efficacy
Complications
Health care resource utilization

Additional relevant MeSH terms:
Lung Neoplasms
Pleural Effusion
Pleural Effusion, Malignant
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pleural Diseases
Pleural Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014