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

NCT06944262 | Recruiting

• 1 other identifier: D2023-02
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer; Healthcare Professionnals; Caregiver Distress; Caregiver; Caregiver Stress Syndrome

Keywords

cancer; trauma; patients; caregivers; dyad; cancer-related post-traumatic stress disorder

Outcome Measures

Primary Outcomes (1)

• PTSD Checklist for DSM-5 (PCL5)

  total score (0-80) reflects the severity of Post Traumatic Stress Disorder (PTSD) symptoms. A score threshold \> 32 has been validated as reflecting probable PTSD

  measured in the month following the announcement of the cancer treatment, then 6 months and 12 months later - in patients and their caregiver

Secondary Outcomes (14)

• self reported general physical condition

  from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later

• perception of the general physical condition in the other dyad member

  from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later

• self reported distress

  from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later

• perception of the distress in the other dyad member

  from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later

• self reported physical pain (only in patients)

  from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later

Study Arms (5)

Part 1 - patients groups

(n = 150) = 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)

Part 1 - caregivers group

(n = 150) = Men or women aged 18 or over, designated by the patient as their primary caregiver (i.e. "a family member, friend or other person who has helped care for you since your diagnosis")

Part 2 - patients

Men or women of legal age who have or have had cancer, Members of a local patient association or of the Oscar Lambret Center's "patient partners" committee. For each type of participant (patients, caregivers, healthcare professionals), 3 focus groups will be set up to collect a sufficient amount of data to reach data saturation (Guest et al., 2017; Wilkinson, 2013). In all, 9 focus groups will be set up. Each group will have between 4 and 8 participants.

Part 2 - caregivers

Men or women of legal age who are or have been caregivers for a cancer patient, members of a local caregivers' association. For each type of participant (patients, caregivers, healthcare professionals), 3 focus groups will be set up to collect a sufficient amount of data to reach data saturation (Guest et al., 2017; Wilkinson, 2013). In all, 9 focus groups will be set up. Each group will have between 4 and 8 participants.

Part 2 - healthcare professionals

Medical and paramedical staff at the Oscar Lambret Center Or non-hospital personnel involved in the medical or psychological care of patients, Professionals not involved in the present study. For each type of participant (patients, caregivers, healthcare professionals), 3 focus groups will be set up to collect a sufficient amount of data to reach data saturation (Guest et al., 2017; Wilkinson, 2013). In all, 9 focus groups will be set up. Each group will have between 4 and 8 participants.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

centre oscar lambret

You may qualify if:

• Part 1. Diagnosis of Ca-PTS
• 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 and an internet connection, for the online questionnaire - the webcam is only necessary if the participant wants the IGE to be present via video on the computer, if they prefer the video to be made over the phone, in which case they must also be equipped with a smartphone enabling video calls.
• Male or female, 18 years of age or older,
• designated by the patient as their primary caregiver (i.e. "a family member, friend or other person who has helped care for you since diagnosis"),
• have given their signed consent to participate in the study.
• equipped with a computer or tablet equipped with a webcam and an internet connection, for the online questionnaire - the webcam is only necessary if the participant wishes the IGE to be present via video on the computer, if he/she prefers the video to be made over the phone, in which case it is also necessary to be equipped with a smartphone enabling video calls.
• Part 2. Gathering expectations for personalized support and its components.

You may not qualify if:

• Part 1. Diagnosis of Ca-PTS
• Patients with meningeal or cerebral metastases,
• Patients with cancer recurrence,
• Patients suffering from a psychiatric or neurological disorder likely to impair their ability to reason or judge (in particular psychotic disorder, autism spectrum disorder, intellectual disability),
• Patients with a psychological or physical incapacity to answer questionnaires, certified by medical staff,
• Patients subject to a custodial sentence, guardianship or protection of vulnerable adults,
• Presence of CNS metastases (risk of cognitive impairment preventing completion of questionnaires).
• Caregivers suffering from a psychiatric or neurological disorder likely to impair their ability to reason or exercise judgment judgment (in particular psychotic disorder, autism spectrum disorder intellectual disability), or for whom there is a suspicion (not there is a suspicion (no additional examination is prescribed to confirm this criterion, which remains self-declaratory).
• Caregivers with a psychological or physical inability to answer questionnaires, or for whom there is a suspicion suspicion (no further tests are required to confirm this criterion which remains self-reported).
• Caregivers subject to a custodial sentence, guardianship or protection guardianship or protection of vulnerable adults.
• Part 2. Collection of expectations for personalized support and its components.
• \- Failure to complete all measurement times (T0, T1, T2)

Sponsors & Collaborators

• Lille University: lead
• Centre Oscar Lambret, Lille, France: collaborator

Study Sites (2)

Centre Oscar Lambret

Lille, Nord, 59000, France

RECRUITING

Centre Oscar Lambret

Lille, Nord, 5900, France

RECRUITING

Related Publications (2)

• Czajkowski SM, Powell LH, Adler N, Naar-King S, Reynolds KD, Hunter CM, Laraia B, Olster DH, Perna FM, Peterson JC, Epel E, Boyington JE, Charlson ME. From ideas to efficacy: The ORBIT model for developing behavioral treatments for chronic diseases. Health Psychol. 2015 Oct;34(10):971-82. doi: 10.1037/hea0000161. Epub 2015 Feb 2.

  PMID: 25642841 BACKGROUND

• Ashbaugh AR, Houle-Johnson S, Herbert C, El-Hage W, Brunet A. Psychometric Validation of the English and French Versions of the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5). PLoS One. 2016 Oct 10;11(10):e0161645. doi: 10.1371/journal.pone.0161645. eCollection 2016.

  PMID: 27723815 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 25, 2025
• Study Start: April 2, 2025
• Primary Completion (Estimated): February 5, 2027
• Study Completion (Estimated): February 2, 2028
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)