Pleural Catheters Versus Thoracoscopic Pleurodesis

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01117740
• Other study ID #: 2010-0103
• Status: Completed
• Phase: N/A
• First received: April 20, 2010
• Last updated: April 8, 2016
• Start date: April 2010
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 445
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Cancer
• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

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.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Patient Responses to MDASI	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	No

External Links

•   University of Texas MD Anderson Cancer Center Website