Reducing pain and emotional distress during gynecologic brachytherapy applicator removal
Official title: 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
Run by M.D. Anderson Cancer Center · NCT07335302 · Data updated 2026-11-12
This project will see if women who receive gynecologic brachytherapy develop PTSD and whether pain, anxiety, or use of propofol during applicator removal are linked to it.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | December 18, 2025 |
| Main results expected | October 20, 2026 |
| Study ends | October 20, 2028 |
| Registry record updated | July 16, 2026 |
| Trial ID | NCT07335302 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult women (age ≥18) receiving multiple intracavitary gynecologic brachytherapy at MD Anderson who can give informed consent and complete repeated patient-reported surveys.
✕Probably not a fit
Patients who are not undergoing intracavitary gynecologic brachytherapy, cannot provide informed consent, or cannot complete the required questionnaires are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project at M.D. Anderson Cancer Center will measure the rate of PTSD in women after multiple intracavitary gynecologic brachytherapy treatments using the Impact of Event Scale - Revision (IES-R). Secondary analyses will examine associations between ASD/PTSD and peri-procedural pain (Brief Pain Inventory), residual pain indicated by hospital readmissions, treatment-related anxiety and depression (HADS), quality of life (EORTC QLQ-C30 with CX24), and patient-requested propofol use. Adult participants will complete patient-reported outcome and satisfaction surveys multiple times during and after their treatment course. No interventions are assigned; data are collected from routine care and questionnaires.
Why it matters
Potential benefit: If successful, this could identify patients at higher risk for PTSD so clinicians can better target pain management and psychological support around applicator removal.
How similar studies have gone: Prior research has shown that invasive cancer procedures and uncontrolled procedural pain can contribute to acute stress and PTSD symptoms, but studying these specific peri-procedure factors around gynecologic brachytherapy applicator removal is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Ann H Klopp, MD, PHD — M.D. Anderson Cancer Center
- Study coordinator: Ann H Klopp, MD, PHD
- Email: aklopp@mdanderson.org
- Phone: (713) 563-2444
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.