CARE-BI Pilot Study to Enhance Comfort and Reduce Psychological Distress in Women Undergoing Gynecologic Brachytherapy Implant Removal

What this Trial Is About

Researchers are studying the frequency of posttraumatic stress disorder PTSD in women who undergo gynecologic brachytherapy. This observational study aims to understand psychological distress during and after this treatment by assessing PTSD rates using the Impact of Event Scale - Revision IES-R. The study also explores how pain during implant removal, residual pain, anxiety, depression, quality of life, and use of propofol relate to stress disorders. Participants are women aged 18 and older who have received multiple intracavitary brachytherapy treatments for gynecologic cancer. They will be evaluated through patient-reported outcome and satisfaction surveys completed multiple times during and after treatment. The research will monitor safety and adverse events over about one year. Throughout the study, women will complete questionnaires assessing pain, anxiety, depression, and quality of life. Hospital readmission rates for pain and requests for propofol sedation will also be recorded. The main measurement focuses on safety and adverse events, with data collected until study completion. Participants involvement includes completing surveys repeatedly to track psychological distress and treatment effects over time.

CARE-BI:a Pilot Study to Improve Patient Comfort and Reduce Psychological Distress During IA Removal