Post-TRaUmatic STress Disorder Induced by Gynecological B... | NCT07204535

Studies
Post-TRaUmatic STress Disorder Induced by Gynecological Brachytherapy

NCT07204535

Sponsor

Centre Paul Strauss

Status

Recruiting

Last Update Posted

Jun 4, 2026Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Uterine Cervical Neoplasms

Interventions

Prospective questionnaires

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2025-A00672-47	Other Identifier	ID-RCB number

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 17, 2025Actual

Primary Completion Date

Nov 17, 2030Estimated

Completion Date

Nov 17, 2031Estimated

First Submitted Date

Sep 24, 2025

First Submission Date that Met QC Criteria

Sep 24, 2025

First Posted Date

Oct 2, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2026

Last Update Posted Date

Jun 4, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

60 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient with cervical cancer with an indication for uterovaginal brachytherapy			Other: Prospective questionnaires

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Anxiety and Depression	Hospital Anxiety and Depression scale	until 60 months
Quality of Life (general module)	Evaluated with EORTC QLQ-C30 questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Valérie SARTORI	Contact	368767223	33	promotion-rc@icans.eu
Claire VIT	Contact	388258529	33	c.vit@icans.eu

Overall Officials

Name	Affiliation	Role
George NOEL, MD, PhD	ICANS, CPS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Groupement Hospitalier Sud - Hopital Lyon Sud	Recruiting	Pierre-Bénite		69495	France

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms
D013313	Stress Disorders, Post-Traumatic

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided