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Recruiting Observational

Post-TRaUmatic STress Disorder Induced by Gynecological Brachytherapy

NCT07204535 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-11-17
Last updated
2026-06-04

Condition(s) studied

Uterine Cervical Neoplasms

Investigational drug(s) / intervention(s)

Prospective questionnaires

Prospective questionnaires: Post-traumatic stress disorder Checklist version DSM-5 (PCL-5) and quality of life questionnaires

Study 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 cancer using self-administered questionnaires. The study also aims to assess the persistence of these symptoms over time, up to 5 years after brachytherapy. The results could help identify patients at risk of post-traumatic stress in this context and develop appropriate psychological interventions to improve their psychological well-being during and after treatment.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

  • Post-Traumatic Stress Disorder evaluation — at 2 months
    Evaluation with post-traumatic stress disorder Checklist version DSM-5 (PCL-5) - questionnaire with a Cut off score ≥ 32

Trial sites (2)

FacilityCityRegionStatus
Groupement Hospitalier Sud - Hopital Lyon Sud Pierre-Bénite France Recruiting
ICANS Strasbourg France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07204535 on ClinicalTrials.gov ↗ ← All trials in France