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

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ 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.

• 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.

• 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.

• 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.

• 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

Locations
Other Locations
France
Centre Oscar Lambret
RECRUITING
Lille
Centre Oscar Lambret
RECRUITING
Lille
Time Frame
Start Date: 2025-04-02
Estimated Completion Date: 2028-02-02
Participants
Target number of participants: 350
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Centre Oscar Lambret, Lille, France
Leads: Lille University

This content was sourced from clinicaltrials.gov