Long-Term Longitudinal QoL in Patients Undergoing EEA (NCT04087902) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Long-Term Longitudinal QoL in Patients Undergoing EEA
United States400 participantsStarted 2019-07-16
Plain-language summary
This is a prospective longitudinal study to access postoperative 2-year quality of life in patients who undergo endonasal endoscopic approach surgeries of the skull base.
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:
* Patient is scheduled to undergo endoscopic endonasal surgery. Multiple, staged surgeries are not exclusionary
* 18 years of age or older
* The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent
Exclusion Criteria:
* Patient is a prisoner
* Patient is not English speaking
* Patient is not expected to survive until the 2-year follow-up
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.
1This study is specifically tracking quality of life over the long term after endoscopic endonasal surgery — does my diagnosis, whether it's a pituitary tumor, meningioma, or one of the other conditions listed, make me a good candidate to discuss participating in this kind of follow-up research?
2Since the trial is no longer actively recruiting, is there any chance I could still be enrolled, or is there a similar quality-of-life study at this institution that I could join alongside my treatment?
3The study uses something called the PROMIS-29 to measure quality of life — can you explain what areas of my daily life that questionnaire actually tracks, and how that information might be used to improve care for patients like me in the future?
4How does being part of a longitudinal quality-of-life study like this one differ from being in a treatment trial — meaning, would joining this study change anything about the actual surgery or medical care I receive?
5Given that this is an observational study focused on outcomes after endoscopic endonasal surgery, what does the existing data tell us about what to expect for quality of life after this type of procedure for my specific condition?
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
PROMIS-29 quality of life outcome measures for patients undergoing endoscopic endonasal surgeries.