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NCT Number: NCT07204535

Post-TRaUmatic STress Disorder Induced by Gynecological Brachytherapy

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Groupement Hospitalier Sud - Hopital Lyon Sud, Pierre-Bénite, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prospective questionnaires

Other

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

Primary outcomes

  1. Post-Traumatic Stress Disorder evaluation

    Time frame: at 2 months

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

Secondary outcomes

  1. Anxiety and Depression

    Time frame: until 60 months

    Hospital Anxiety and Depression scale

  2. Quality of Life (general module)

    Time frame: until 60 months

    Evaluated with EORTC QLQ-C30 questionnaire

  3. Quality of Life (cervical cancer module)

    Time frame: until 60 months

    Evaluated with EORTC QLQ-CX24 questionnaire

  4. Sexual Health evaluation

    Time frame: until 60 months

    Sexual Health Questionnaire (EORTC SHQ-22)

Study contacts

Contact information is provided by the study sponsor or research team.

Claire VIT

CONTACT

[email protected]

388258529 ext. 33

Valérie SARTORI

CONTACT

[email protected]

368767223 ext. 33

Sponsors and collaborators

Lead sponsor

Centre Paul Strauss

Other

Registry information

Acronym: TRUST-GB

Important dates

Study start
2025
Primary completion
2030
Study completion
2031
First posted
Oct 2, 2025
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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