Post-TRaUmatic STress Disorder Induced by Gynecological Brachytherapy

NCT ID: NCT07204535

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-27

Study Completion Date

2031-10-27

Brief Summary

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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.

Detailed Description

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Conditions

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Uterine Cervical Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient with cervical cancer with an indication for uterovaginal brachytherapy

Prospective questionnaires

Intervention Type OTHER

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

Interventions

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Prospective questionnaires

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Paul Strauss

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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George NOEL, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

ICANS, CPS

Locations

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ICANS

Strasbourg, , France

Site Status

Countries

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France

Central Contacts

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Valérie SARTORI

Role: CONTACT

368767223 ext. 33

Claire VIT

Role: CONTACT

388258529 ext. 33

Facility Contacts

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George NOEL, MD, PhD

Role: primary

368766767 ext. 33

Other Identifiers

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2025-A00672-47

Identifier Type: OTHER

Identifier Source: secondary_id

2024-004

Identifier Type: -

Identifier Source: org_study_id

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