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Recruiting NCT07335302

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

◆ AI Clinical Summary

This study looks at how women feel emotionally after having a type of cancer treatment called gynecologic brachytherapy, which involves placing radiation inside the body. Researchers want to understand how often women experience stress symptoms after this procedure and find ways to help them feel more comfortable during treatment.

Key Objective: This trial tests whether improved comfort measures during the procedure can reduce psychological distress and PTSD symptoms in women undergoing gynecologic brachytherapy.

Who to Consider: Women who are undergoing or have recently undergone gynecologic brachytherapy for cancer treatment and want to help improve the experience for future patients should consider enrolling.

Trial Parameters

Condition Psychological Distress
Sponsor M.D. Anderson Cancer Center
Study Type OBSERVATIONAL
Phase N/A
Enrollment 36
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-12-18
Completion 2026-10-20

Brief 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.

Eligibility Criteria

Inclusion Criteria: * Capable of signing informed consent * Age ≥ 18 years old * Receipt of multiple intracavitary brachytherapy treatments for gynecologic cancer * Capable of completing PRO and patient satisfaction surveys and willing to comply with completion of surveys multiple times throughout and after treatment Exclusion Criteria: * Patients without ability to sign informed consent * Patients unwilling or unable to complete PRO and patient satisfaction surveys at the times required by the study

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