Post-therapy stress symptoms after gynecologic brachytherapy in cervical cancer
Official title: Post-TRaUmatic STress Disorder Induced by Gynecological Brachytherapy
Run by Centre Paul Strauss · NCT07204535 · Data updated 2026-11-12
This study tests whether patients undergoing uterovaginal brachytherapy for cervical cancer develop post-traumatic stress symptoms and how these symptoms change over up to 5 years.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 80 (estimated) |
| Sponsor | Centre Paul Strauss Academic / other |
| Locations | 2 sites (Pierre-Bénite and 1 other locations) |
| Status | Recruiting |
| Started | November 17, 2025 |
| Main results expected | November 17, 2030 |
| Study ends | November 17, 2031 |
| Registry record updated | June 4, 2026 |
| Trial ID | NCT07204535 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with cervical cancer indicated for HDR or PDR uterovaginal brachytherapy who can complete validated French questionnaires and provide informed consent.
✕Probably not a fit
Patients who do not experience significant distress or who are unable to complete questionnaires due to language, cognitive, or psychiatric barriers may derive minimal direct benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, prospective observational study collects self-reported data to document psychological effects, including post-traumatic stress symptoms, in women treated with HDR or PDR uterovaginal brachytherapy for cervical cancer. Participants complete validated questionnaires in French, with follow-up to five years to observe persistence or changes in symptoms. The goal is to identify risk factors and inform potential psychological support strategies during and after treatment. No experimental interventions are involved beyond questionnaire assessments, and results may guide future care pathways.
Why it matters
Potential benefit: If successful, the study could improve understanding of who is at risk for post-traumatic stress after brachytherapy and help tailor supportive care to improve well-being.
How similar studies have gone: Prior research in cancer care has shown links between treatment-related stress and psychological symptoms, but this specific brachytherapy-focused, long-term observational approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Groupement Hospitalier Sud - Hopital Lyon Sud
Pierre-Bénite, France Recruiting -
Icans
Strasbourg, France Recruiting
Study contacts
- Principal investigator: George NOEL, MD, PhD — Icans, Cps
- Study coordinator: Valérie SARTORI
- Email: promotion-rc@icans.eu
- Phone: 368767223
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.