Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID06944262

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

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

350

Participants Needed

2

Research Sites

51 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

This research investigates the emotional and psychological impact of cancer on patients and their caregivers, focusing on the development of cancer-related post-traumatic stress disorder (Ca-PTS). It recognizes that patients and caregivers may have faced previous traumatic events, which could increase their risk of distress during the cancer care journey. The study aims to identify groups at risk of Ca-PTS and understand their needs for personalized support throughout the year following diagnosis. Participants include patients recently diagnosed (within 4 months) with specific cancers such as breast, gynecological, testicular, or digestive cancers, and their primary caregivers. The study involves longitudinal screening for Ca-PTS at the time of treatment announcement, then at 6 and 12 months. Additionally, focus groups with patients, caregivers, and healthcare professionals will explore expectations and preferences for personalized support. Participants will complete questionnaires online at multiple time points to assess PTSD symptoms, physical condition, distress, anxiety, depression, social support, and other factors. The study uses tools like the PTSD Checklist for DSM-5 (PCL5) and collects socio-demographic data. Focus groups conducted remotely will gather detailed qualitative data. The total participation lasts one year, with assessments at baseline, 6 months, and 12 months to monitor emotional adjustment and support needs.

CONDITIONS

Brief 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 requiring oncological treatment
  • Starting oncology treatment at the Oscar Lambret Center
  • No Central Nervous System metastases
  • PRONOPALL score ≤3 or expected survival greater than 6 months
  • Signed consent to participate and covered by French social security
  • Able to identify a primary caregiver who has helped since diagnosis
  • Equipped with a computer or tablet with webcam and internet connection for online questionnaires
  • Caregivers must be designated by the patient as their primary caregiver
  • Caregivers must have signed consent to participate
  • Members of local patient or caregiver associations or patient partners for focus groups
  • Medical and paramedical staff or non-hospital personnel involved in patient care for focus groups
  • Equipped with a computer or tablet with camera and internet connection for focus groups
  • Signed consent for focus group participation
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 CNS metastases
  • Caregivers with psychiatric or neurological disorders impairing reasoning or judgment, or suspected
  • Caregivers with psychological or physical inability to answer questionnaires, or suspected
  • Caregivers under custodial sentence, guardianship, or protection of vulnerable adults
  • Failure to complete all measurement times (T0, T1, T2) for patients and caregivers in screening part
  • No exclusion criteria for focus group participants (patients, caregivers)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote) within 4 months following cancer diagnosis

Monitoring

Duration - 12 months following cancer diagnosis

Participants complete questionnaires and assessments about post-traumatic stress and related factors at multiple time points following their cancer diagnosis.

3 assessment time points: baseline (within 1 month after treatment announcement), 6 months, and 12 months later

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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Published Research Related To This Trial

Psychometric Validation of the English and French Versions of the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5).

Andrea R Ashbaugh, Stephanie Houle-Johnson, Christophe Herbert...

https://pubmed.ncbi.nlm.nih.gov/27723815