Uterine Cervical Neoplasms
Conditions
Keywords
Brachytherapy, Post-TRaUmatic STress Disorder, Cervical cancer
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.
Interventions
OTHERProspective questionnaires
Post-traumatic stress disorder Checklist version DSM-5 (PCL-5) and quality of life questionnaires
Sponsors
Centre Paul Strauss
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
France
Contacts
CONTACTValérie SARTORI
CONTACTClaire VIT
PRINCIPAL_INVESTIGATORGeorge NOEL, MD, PhD
ICANS, CPS
Outcome results
None listed