RecruitingNCT07204535

Post-TRaUmatic STress Disorder Induced by Gynecological Brachytherapy


Sponsor

Centre Paul Strauss

Enrollment

80 participants

Start Date

Nov 17, 2025

Study Type

OBSERVATIONAL

Conditions

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: FEMALEMin Age: 18 Years

Inclusion Criteria6

  • 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 Criteria3

  • 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

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Interventions

OTHERProspective questionnaires

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


Locations(2)

Groupement Hospitalier Sud - Hopital Lyon Sud

Pierre-Bénite, France

ICANS

Strasbourg, France

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NCT07204535


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