RecruitingNCT06944262

Assessment of Cancer-related Post-traumatic Stress in Patients and Caregivers in the Year Following Diagnosis, and Identification of Their Expectations of Personalized Support - CANDYSTRESS

Évaluation de la détresse Post-traumatique Relative au Cancer Dans l'année Suivant le Diagnostic Chez Les Patients et Les Aidants et Identification de Leurs Attentes Envers un Accompagnement personnalisé


Sponsor

Lille University

Enrollment

350 participants

Start Date

Apr 2, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

The impact of cancer on the lives of patients and their caregivers is undeniable. In addition to the potentially traumatic aspects (i.e., creating a very violent emotional shock) linked to the announcement of the disease and the various stages of the care pathway (effects of treatment, announcement of a cancer recurrence), even before the onset of the disease, patients and their caregivers may have been directly or indirectly confronted with traumatogenic events (e.g., childhood abuse, sudden death). They may therefore be more likely to develop a stress-related mental disorder in their lifetime. The question of the accumulation of traumatic events, the identification of groups of people at risk of developing symptoms of distress, and the management of these symptoms is therefore crucial. In addition, the mutual influence within the patient-caregiver dyad in terms of emotional adjustment, and its evolution throughout the cancer care pathway, are key elements to be considered in these issues. The CandyStress project is based on a partnership with patients, their caregivers and carers to identify the needs of patient-caregiver dyads at risk of cancer-related post-traumatic stress disorder (Ca-PTS). Longitudinal screening for Ca-PTS in the year following cancer diagnosis will be carried out to identify the characteristics of at-risk dyads who could benefit from long-term support. The aim of this project is to identify the potential need for targeted support and the desired format of this support. This is a preliminary step in identifying needs and the context conducive to the implementation of personalized support, but in no way an evaluation of the effectiveness of an intervention.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how cancer diagnoses affect the mental health of patients and their caregivers — specifically examining whether people develop post-traumatic stress symptoms after receiving a cancer diagnosis, and what kind of support they would find most helpful. **You may be eligible if...** - You are 18 years of age or older - You were recently diagnosed (within the last 4 months) with breast, gynecological, testicular, or digestive cancer - You are starting cancer treatment at the participating cancer center - You are a caregiver or family member of someone with a recent cancer diagnosis (caregiver arm) - You have no cancer spread to the brain **You may NOT be eligible if...** - You have already started treatment elsewhere or have been diagnosed for longer than 4 months - You have cancer that has spread to the central nervous system - You are unable to provide informed consent or complete study assessments - You are under 18 years old Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(2)

Centre Oscar Lambret

Lille, Nord, France

Centre Oscar Lambret

Lille, Nord, France

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NCT06944262


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