Understanding Psychological Distress After Gynecologic Brachytherapy
This study aims to understand how often women experience post-traumatic stress disorder (PTSD) after receiving intracavitary brachytherapy (a type of radiation therapy where a radioactive source is placed inside the body) for gynecologic cancer. Researchers will also look at how factors like pain during implant removal, anxiety, depression, quality of life, and the use of propofol (a medicine used for sedation) might be connected to PTSD and acute stress disorder (ASD). This is an observational study, meaning participants will be monitored without receiving a specific intervention from the study. The study plans to enroll 36 women aged 18 or older who have had multiple intracavitary brachytherapy treatments for gynecologic cancer and can complete surveys. The study's success will be measured by tracking safety and any side effects. The current recruitment status is unclear.
- Study design
- This is an observational study that plans to include 36 participants. It is not specified if it is randomized or blinded.
- What's involved
- You would need to complete patient surveys multiple times throughout and after your treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety and adverse events will be measured through study completion, which is an average of 1 year.
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CARE-BI:a Pilot Study to Improve Patient Comfort and Reduce Psychological Distress During IA Removal
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Ann H Klopp, MD, PHD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Safety and Adverse Events (AEs).Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0