Post-TRaUmatic STress Disorder Induced by Gynecological Brachytherapy

Not yet recruiting

• Conditions: Uterine Cervical Neoplasms

• Registration Number: NCT07204535
• Lead Sponsor: Centre Paul Strauss

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-24
• Study First Submitted QC: 2025-09-24
• Last Update Submitted: 2025-09-24
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02
• Study Start: 2025-10-27
• Primary Completion: 2030-10-27
• Study Completion: 2031-10-27

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Anxiety and Depression	until 60 months	Hospital Anxiety and Depression scale
Quality of Life (general module)	until 60 months	Evaluated with EORTC QLQ-C30 questionnaire
Quality of Life (cervical cancer module)	until 60 months	Evaluated with EORTC QLQ-CX24 questionnaire
Sexual Health evaluation	until 60 months	Sexual Health Questionnaire (EORTC SHQ-22)

Trial Locations

Locations (1)

ICANS; 🇫🇷 Strasbourg, France