Clinical trial NCT01117740: Pleural Catheters Versus Thoracoscopic Pleurodesis
Official title: Comparative Effectiveness of Indwelling Pleural Catheters Versus Thoracoscopic Pleurodesis for Treatment of Malignant Pleural Effusions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: 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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2010-05-05
Enrollment: 445
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: Quality-Adjusted Survival Times
timeFrame: 12 Months with follow up until death or recurrence
Secondary outcomes:
measure: Patient Responses to MDASI
timeFrame: Monthly beginning at pleural effusion treatment
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: David Ost, MD
role: STUDY_CHAIR
References:
citation: 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.