Lung CancerNCT01117740
Pleural Catheters Versus Thoracoscopic Pleurodesis
An observational study of Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- MDASI Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 445 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients, 18 years or older, with malignant pleural effusions, suitable for either pleural catheter placement or thoracoscopic pleurodesis.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- MDASI Questionnaire
- 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
- Medical subject headings
- Lung Neoplasms, Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDASI QuestionnaireBehavioural
Also called Survey
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.
| Study group | Role | What they receive |
|---|---|---|
| Thoracoscopy Group | Not described Receives: Behavioral: MDASI Questionnaire | |
| Indwelling Pleural Catheters | Not described Receives: Behavioral: MDASI Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Months with follow up until death or recurrence
Secondary outcomes (1)
Patient Responses to MDASI
- D. Anderson Symptom Inventory (MDASI) symptoms questionnaire: 19 questions about symptoms rated on a scale of 1-10.
Measured: Monthly beginning at pleural effusion treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 445 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Ost, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117740
- Sponsor's protocol ID
- 2010-0103
- Status last verified
- Apr 2016
- First submitted
- 20 Apr 2010
- Last updated
- 11 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24480929
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Indwelling Pleural Catheters Versus Thoracoscopic Pleurodesis for Treatment of Malignant Pleural Effusions
- ClinicalTrials.gov ID
- NCT01117740
- Acronym / sponsor ID
- 2010-0103
- Conditions
- Lung Cancer
- Keywords
- Malignant Pleural Effusions, MPE, Lungs, Quality of Life, M. D. Anderson Symptom Inventory, MDASI, Indwelling Pleural Catheters, Thoracoscopic Pleurodesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 445 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 5 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracoscopy Group | – | Behavioral: MDASI Questionnaire |
| Indwelling Pleural Catheters | – | Behavioral: MDASI Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, 18 years or older, with malignant pleural effusions, suitable for either pleural catheter placement or thoracoscopic pleurodesis.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDASI QuestionnaireAlso: Survey19 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. | Behavioural | Indwelling Pleural Catheters, Thoracoscopy Group |
Primary outcome
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.
1 secondary outcome
Patient Responses to MDASI
Time frame: Monthly beginning at pleural effusion treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2016.
- Derived from this study: PubMed 24480929Ost 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.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Lung Cancer
Recruiting
MRD-Guided Postoperative Surveillance and Adaptive Treatment for Resectable Lung Cancer
Lung Neoplasms, Neoadjuvant Therapy
Not yet recruitingPhase 3
Intraarterial Therapies Plus Tislelizumab Plus Lenvatinib Versus Tislelizumab Plus Gemcitabine-Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma (Icc)
Active, not recruitingPhase 3
A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer
Non-small Cell Lung Cancer Stage IV
RecruitingObservational study
Label-free Femtosecond Laser Imaging Combined With the Fast Lung Artificial Intelligence Model for Rapid Intraoperative Diagnosis of Lung Surgical Specimens: A Multicentre, Prospective, Parallel-workflow, Non-inferiority Study.
Lung Cancer
RecruitingPhase 3
A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
Non-small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Ost, MD study chair
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality-Adjusted Survival Times (time frame: 12 Months with follow up until death or recurrence). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01117740, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2016.