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Recruiting NCT06944262

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

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Trial Parameters

Condition Cancer
Sponsor Lille University
Study Type OBSERVATIONAL
Phase N/A
Enrollment 350
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-04-02
Completion 2027-02-05

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Brief 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 Criteria

Inclusion Criteria: Part 1. Diagnosis of Ca-PTS Patient inclusion criteria: * Male or female, 18 years of age or older, * recently (\<4 months) diagnosed with breast, gynecological, testicular or digestive cancer at the time of the announcement visit (i.e., the announcement to the patient of the treatment plan after the initial multidisciplinary consultation meeting in the cancer center - in accordance with the Cancer Plan), * with cancer requiring oncological treatment, * starting oncology treatment at the Oscar Lambret Center, * with no Central Nervous System (CNS) metastases, * with a PRONOPALL score ≤3 (favorable prognosis group, Bourgeois et al., 2017) or expected survival greater than 6 months, * who have given signed consent to participate in the study and are covered by French social security, * able to identify a caregiver (i.e., a family member, friend or other person who has helped care for them since diagnosis). * equipped with a computer or tablet equipped with a webcam an

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