Actively Recruiting
CARE-BI: a Pilot Study to Improve Patient Comfort and Reduce Psychological Distress During Intracavitary Applicator Removal
Led by M.D. Anderson Cancer Center · Updated on 2026-01-13
36
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand the rate of posttraumatic stress disorder (PTSD) experienced by women who have undergone gynecologic brachytherapy. Specifically, it assesses PTSD through the Impact of Event Scale - Revision (IES-R) and explores the connection between PTSD or Acute Stress Disorder (ASD) with factors such as pain during implant removal, residual pain after treatment, anxiety and depression levels, quality of life, and the use of propofol for sedation. The study observes women who have received multiple intracavitary brachytherapy treatments for gynecologic cancer. It collects data on pain experienced during and after treatment using tools like the Brief Pain Inventory and monitors anxiety and depression with the Hospital Anxiety and Depression Scale. Quality of life is evaluated with specialized questionnaires designed for cancer patients, and the use of sedation medication upon patient request is also recorded. Participants will complete patient-reported outcome and satisfaction surveys multiple times throughout and after their treatment. Researchers will monitor safety and adverse events during the study, which lasts about one year on average. The study focuses on gathering detailed information about psychological distress and patient comfort during and after brachytherapy implant removal to improve care strategies.
CONDITIONS
Brief Title
CARE-BI:a Pilot Study to Improve Patient Comfort and Reduce Psychological Distress During IA Removal
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Capable of signing informed consent
- Age 18 years or older
- Received multiple intracavitary brachytherapy treatments for gynecologic cancer
- Able and willing to complete patient-reported outcome and satisfaction surveys multiple times throughout and after treatment
You will not qualify if you...
- Unable to sign informed consent
- Unwilling or unable to complete patient-reported outcome and satisfaction surveys as required by the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants who have received intracavitary brachytherapy are observed for psychological distress and pain, completing multiple patient-reported outcome and satisfaction surveys throughout and after treatment.
Multiple survey assessments during and after treatment
Trial Site Locations
Total: 1 location
1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Ann H Klopp, MD, PHD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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