Rocket® Pleural Catheters: QOL, Feasibility and Satisfaction in Recurrent MPE Patients (NCT03403855) | Clinical Trial Compass
UnknownNot Applicable
Rocket® Pleural Catheters: QOL, Feasibility and Satisfaction in Recurrent MPE Patients
Canada100 participantsStarted 2018-03-07
Plain-language summary
This study will take place in Ottawa, Ontario, and will include 100 patients who are receiving tunnelled pleural catheters to treat their symptoms of MPE. The aim of this study is to evaluate the effectiveness of the shorter versus longer external length Rocket® pleural catheter in managing malignant pleural effusions in terms of patients' self-rated quality of life, its ease of use, the incidence of complications, and levels of health care provider satisfaction.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Presence of symptomatic (BDI \< 6), and moderate sized (\> 1/3 of hemithorax) MPE
. Persistent malignant pleural effusion that is free flowing
. Life expectancy of at least 2 months (approximate duration of follow-up for the study)
. Age greater than 18
. Consent to undergoing TPC treatment for recurrent MPE
Exclusion criteria
. Prior attempted chemical pleurodesis on ipsilateral side
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patients' self-rated quality of life - change from baseline compared to 2 and 4 weeks post catheter insertion.
Timeframe: Assessed at baseline compared to changes at 2 weeks and 4 weeks post catheter insertion. Questionnaires will be administered at routine medical visits on day O, 14, and 28.
2
Patients' self-rated quality of life on domains specific to lung cancer-change from baseline compared to 2 and 4 weeks post catheter insertion.
Timeframe: Assessed at baseline compared to changes at 2 weeks and 4 weeks post catheter insertion. Questionnaires will be administered at routine medical visits on day O, 14, and 28.