Status:
NOT_YET_RECRUITING
Post-TRaUmatic STress Disorder Induced by Gynecological Brachytherapy
Lead Sponsor:
Centre Paul Strauss
Conditions:
Uterine Cervical Neoplasms
Eligibility:
FEMALE
18+ years
Brief Summary
This is a multicenter, prospective study aimed at providing information on the psychological effects (including post-traumatic stress symptoms) of utero-vaginal brachytherapy in patients with cervical...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of cervical cancer with an indication for High-dose rate (HDR) or pulse-dose rate (PDR) uterovaginal brachytherapy;
- Squamous cell carcinoma or other histological types;
- WHO ≤ 2;
- Ability to complete validated questionnaires in French;
- Informed consent to participate in the study;
- Patients over 18 years old
Exclusion
- Inability to understand or respond to questionnaires due to a cognitive disorder, intellectual disability, language barrier, or psychiatric disorder that impairs judgment;
- Patient under juridic protection;
- Pregnant or breastfeeding woman
Key Trial Info
Start Date :
October 27 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 27 2031
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07204535
Start Date
October 27 2025
End Date
October 27 2031
Last Update
October 2 2025
Active Locations (1)
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1
ICANS
Strasbourg, France, 67033