NCT07335302

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

CARE-BI (Comfort and Analgesia for Removal of Brachytherapy Implants): a Pilot Study to Improve Patient Comfort and Reduce Psychological Distress During Intracavitary Applicator Removal

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 36 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this research study is to learn about the rate of posttraumatic stress disorder (PTSD) experienced by women after undergoing gynecologic brachytherapy.

Detailed description

Primary Objective: To assess the rate of PTSD experienced by women at MD Anderson after receipt of gynecologic brachytherapy as per scores on the Impact of Event Scale - Revision (IES-R) Secondary Objective: To evaluate whether rates of Acute Stress Disorder (ASD) and Posttraumatic Stress Disorder (PTSD) are associated with factors including pain during implant removal as per the Brief Pain Inventory (BPI), residual pain after treatment completion per hospital readmission rates for uncontrolled pain, elevated treatment related anxiety and depression per Hospital Anxiety and Depression Scale (HADS), overall quality of life per the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 with the accompanying Cervical Cancer 24 Module (EORTC QLQ-C30 CX24), and propofol use per patient request.

Conditions

• Psychological Distress

Timeline

• Start date: 2025-12-18
• Primary completion: 2026-10-20
• Completion: 2028-10-20
• First posted: 2026-01-13
• Last updated: 2026-01-13

Locations

1 site across 1 country: United States