Clinical trial · Observational
Post-TRaUmatic STress Disorder Induced by Gynecological Brachytherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prospective questionnaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patient with cervical cancer with an indication for uterovaginal brachytherapy
- interventionNames
- Other: Prospective questionnaires
Primary outcomes (1)
- measure
- Post-Traumatic Stress Disorder evaluation
- timeFrame
- at 2 months
- description
- Evaluation with post-traumatic stress disorder Checklist version DSM-5 (PCL-5) - questionnaire with a Cut off score ≥ 32
Secondary outcomes (4)
- measure
- Anxiety and Depression
- timeFrame
- until 60 months
- description
- Hospital Anxiety and Depression scale
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available