Understanding cancer-related stress in patients and their caregivers

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

This study looks at how cancer affects both patients and their caregivers, especially in terms of stress and emotional challenges, to better understand their experiences and needs for support.

Quick facts

• Study type: Observational
• Enrollment: 350 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Lille University (Academic / other)
• Locations: 2 sites (Lille, Nord and 1 other locations)
• Trial ID: NCT06944262 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the impact of cancer on patients and their caregivers, focusing on the development of post-traumatic stress symptoms following a cancer diagnosis. It will explore the accumulation of traumatic events and identify individuals at risk of distress, while also examining the emotional dynamics within the patient-caregiver relationship throughout the cancer care pathway. Participants will include recently diagnosed cancer patients and their identified caregivers, who will provide insights into their experiences and expectations for personalized support.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older, recently diagnosed with specific types of cancer and starting oncological treatment.

Not a fit: Patients with Central Nervous System metastases or those with a poor prognosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved support strategies for cancer patients and their caregivers, enhancing their emotional well-being.

How similar studies have performed: While the approach of assessing trauma-related stress in cancer patients is recognized, this specific study's focus on the patient-caregiver dyad is relatively novel.

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 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.

Inclusion criteria for caregivers:

* 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.

In addition, 3 types of focus groups will be set up remote :

Focus groups with patients from local associations, as well as patient partners of the Oscar Lambret Center and patients from Part 1 if they are interested.

Inclusion criteria for patient focus groups:

* 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,
* Or have participated in part 1 (Ca-PTS screening, once the 3 steps have been completed),
* Equipped with a computer or tablet with camera and internet connection,
* Have given their consent to take part in the study.

Focus group with caregivers from local associations as well as "partner caregivers" from the Oscar Lambret Center and caregivers from part 1 if they are interested.

Inclusion criteria for "caregiver" focus groups:

* Men or women of full age who are, or have been, caregivers of a cancer patient,
* members of a local caregivers' association,
* or having participated in part 1 (Ca-PTS screening, once the 3 steps have been completed),
* Equipped with a computer or tablet with camera and internet connection,
* Having given their consent to take part in the study.

Focus groups with hospital medical and paramedical staff as well as non-hospital caregivers involved in the medical in the medical and psychological follow-up of patients.

Inclusion criteria for caregiver focus groups:

* Member of the medical and paramedical staff of the Oscar Lambret Center
* Or non-hospital staff involved in the medical or psychological care of patients,
* Professionals not involved in the present study,
* Equipped with a computer or tablet with camera and internet connection
* Having given their consent to participate in the study

Exclusion Criteria:

Part 1. Diagnosis of Ca-PTS

Non inclusion criteria for patients :

* 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).

Non-inclusion criteria for caregivers:

* 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.

Non-inclusion criteria for patients and caregivers who participated in the screening part of the Ca-PTS :

\- Failure to complete all measurement times (T0, T1, T2)

Non-inclusion criteria for focus groups (patients, caregivers): none

Where this trial is running

Lille, Nord and 1 other locations

• Centre Oscar Lambret — Lille, Nord, France (Recruiting)
• Centre Oscar Lambret — Lille, Nord, France (Recruiting)

Conditions Cancer; Healthcare Professionnals; Caregiver Distress; Caregiver; Caregiver Stress Syndrome; cancer; trauma; patients