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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NCT07335302

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

Recruiting
Not specifiedAges 18+Observational
M.D. Anderson Cancer Center
~36 participants
Updated 2026-07-16 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events (AEs).
Measured over Through study completion; an average of 1 year
Psychological Distress
1 sites across 1 states
Texas1
  • Ann H Klopp, MD, PHD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

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Eligibility criteria

Inclusion

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

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
  • 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