Post-TRaUmatic STress Disorder Induced by Gynecological Brachytherapy

NCT07204535 | Not Yet Recruiting

• 2 other identifiers: 2024-0042025-A00672-47
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Cervical Neoplasms

Keywords

Brachytherapy; Post-TRaUmatic STress Disorder; Cervical cancer

Outcome Measures

Primary Outcomes (1)

• Post-Traumatic Stress Disorder evaluation

  Evaluation with post-traumatic stress disorder Checklist version DSM-5 (PCL-5) - questionnaire with a Cut off score ≥ 32

  at 2 months

Secondary Outcomes (4)

• Anxiety and Depression

  until 60 months

• Quality of Life (general module)

  until 60 months

• Quality of Life (cervical cancer module)

  until 60 months

• Sexual Health evaluation

  until 60 months

Study Arms (1)

Patient with cervical cancer with an indication for uterovaginal brachytherapy

Other: Prospective questionnaires

Interventions

Prospective questionnaires OTHER

Post-traumatic stress disorder Checklist version DSM-5 (PCL-5) and quality of life questionnaires

Patient with cervical cancer with an indication for uterovaginal brachytherapy

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with cervical cancer with an indication for High-dose rate (HDR) or pulse-dose rate (PDR) uterovaginal brachytherapy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Paul Strauss: lead

Study Sites (1)

ICANS

Strasbourg, 67033, France

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• George NOEL, MD, PhD

  ICANS, CPS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valérie SARTORI

CONTACT

368767223; promotion-rc@icans.eu

Claire VIT

CONTACT

388258529; c.vit@icans.eu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: October 27, 2025
• Primary Completion (Estimated): October 27, 2030
• Study Completion (Estimated): October 27, 2031
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

FR (1)