Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
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

Led by Lille University · Updated on 2025-04-25

350

Participants Needed

2

Research Sites

148 weeks

Total Duration

On this page

Sponsors

L

Lille University

Lead Sponsor

C

Centre Oscar Lambret, Lille, France

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, 18 years of age or older
  • Recently (less than 4 months) diagnosed with breast, gynecological, testicular, or digestive cancer
  • Cancer requires oncological treatment
  • Starting oncology treatment at the Oscar Lambret Center
  • No Central Nervous System metastases
  • PRONOPALL score of 3 or less or expected survival greater than 6 months
  • Signed consent to participate and covered by French social security
  • Able to identify a primary caregiver (family member, friend, or other person helping since diagnosis)
  • Equipped with a computer or tablet with webcam and internet connection for online questionnaires
  • Caregivers must be 18 years or older, designated by the patient as primary caregiver, and have signed consent
  • Caregivers must also have computer or tablet with webcam and internet connection
Not Eligible

You will not qualify if you...

  • Patients with meningeal or cerebral metastases
  • Patients with cancer recurrence
  • Patients with psychiatric or neurological disorders impairing reasoning or judgment (e.g., psychotic disorder, autism spectrum disorder, intellectual disability)
  • Patients with psychological or physical incapacity to answer questionnaires, certified by medical staff
  • Patients under custodial sentence, guardianship, or protection of vulnerable adults
  • Presence of Central Nervous System metastases
  • Caregivers with psychiatric or neurological disorders impairing reasoning or judgment, or suspected such disorders
  • Caregivers with psychological or physical inability to answer questionnaires, or suspected such inability
  • Caregivers under custodial sentence, guardianship, or protection of vulnerable adults
  • Failure to complete all measurement times (T0, T1, T2) for patients and caregivers participating in screening part

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Centre Oscar Lambret

Lille, Nord, France, 59000

Actively Recruiting

2

Centre Oscar Lambret

Lille, Nord, France, 5900

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

5

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