Post-TRaUmatic STress Disorder Induced by Gynecological Brachytherapy

NCT07204535NOT_YET_RECRUITINGOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

Centre Paul Strauss

Enrollment

80

Start Date

2025-10-27

Completion Date

2030-10-27

Study Type

OBSERVATIONAL

Official Title

Post-TRaUmatic STress Disorder Induced by Gynecological Brachytherapy

Interventions

Prospective questionnaires

Conditions

Uterine Cervical Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Post-Traumatic Stress Disorder evaluation

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

Time frame: at 2 months

Secondary Outcomes

Anxiety and Depression

Hospital Anxiety and Depression scale

Time frame: until 60 months

Quality of Life (general module)

Evaluated with EORTC QLQ-C30 questionnaire

Time frame: until 60 months

Quality of Life (cervical cancer module)

Evaluated with EORTC QLQ-CX24 questionnaire

Time frame: until 60 months

Sexual Health evaluation

Sexual Health Questionnaire (EORTC SHQ-22)

Time frame: until 60 months

Locations

ICANS, Strasbourg, France

Post-TRaUmatic STress Disorder Induced by Gynecological Brachytherapy