Post-TRaUmatic STress Disorder Induced by Gynecological Brachytherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prospective questionnaires.
- Who it may be relevant to
- Registry conditions: Uterine Cervical Neoplasms. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Prospective questionnaires
Post-traumatic stress disorder Checklist version DSM-5 (PCL-5) and quality of life questionnaires
Primary outcome measures
- Post-Traumatic Stress Disorder evaluation [Time frame: at 2 months]
Secondary outcome measures (4)
- Anxiety and Depression [Time frame: until 60 months]
- Quality of Life (general module) [Time frame: until 60 months]
- Quality of Life (cervical cancer module) [Time frame: until 60 months]
- Sexual Health evaluation [Time frame: until 60 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 2 centers
- Groupement Hospitalier Sud - Hopital Lyon Sud — Pierre-Bénite
- ICANS — Strasbourg
Identifiers
NCT: NCT07204535 · 2024-004 · 2025-A00672-47