Clinical trial Recruiting at 2 sites Observational Ages 18 and up Women only

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.

More Uterine Cervical Neoplasms trials

Quick facts

Study typeObservational
Ages18 Years and up
SexWomen only
Enrollment80 (estimated)
SponsorCentre Paul Strauss
Academic / other
Locations2 sites (Pierre-Bénite and 1 other locations)
StatusRecruiting
StartedNovember 17, 2025
Main results expectedNovember 17, 2030
Study endsNovember 17, 2031
Registry record updatedJune 4, 2026
Trial IDNCT07204535 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.