Post-TRaUmatic STress Disorder Induced by Gynecological Brachytherapy (TRUST-GB)

Centre Paul Strauss

Status: Not yet enrolling

Conditions: Uterine Cervical Neoplasms

Treatments: Other: Prospective questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT07204535

2024-004

2025-A00672-47 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 1 patient group

Patient with cervical cancer with an indication for uterovaginal brachytherapy

Treatment:

Other: Prospective questionnaires