Health TrialsbyHealthPanel

Post-TRaUmatic STress Disorder Induced by Gynecological Brachytherapy

ConditionUterine Cervical Neoplasms
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorCentre Paul Strauss

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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 population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Prospective questionnaires

    Other intervention

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

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Patient with cervical cancer with an indication for uterovaginal brachytherapy1 intervention

Trial outcomes

Primary outcomes

1

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

1

Anxiety and Depression

Hospital Anxiety and Depression scale

Time frame
until 60 months
2

Quality of Life (general module)

Evaluated with EORTC QLQ-C30 questionnaire

Time frame
until 60 months
3

Quality of Life (cervical cancer module)

Evaluated with EORTC QLQ-CX24 questionnaire

Time frame
until 60 months
4

Sexual Health evaluation

Sexual Health Questionnaire (EORTC SHQ-22)

Time frame
until 60 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Paul Strauss

Lead sponsor

Source ClinicalTrials.gov
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