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.
Study Type
OBSERVATIONAL
Enrollment
350
Centre Oscar Lambret
Lille, Nord, France
RECRUITINGCentre Oscar Lambret
Lille, Nord, France
RECRUITINGPTSD 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
Time frame: measured in the month following the announcement of the cancer treatment, then 6 months and 12 months later - in patients and their caregiver
self reported general physical condition
answer to the item "How do you feel physically impaired at the moment?" (likert scale from 0: "not at all" to 10: "absolutely")
Time frame: 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
answer to the item:: "To what extent do you think your loved one feels physically diminished at the moment? " (likert scale from 0: "not at all" to 10: "absolutely")
Time frame: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
self reported distress
answer to the item "To what extent do you feel psychologically distressed at the moment? " ((likert scale from 0: "not at all" to 10: "absolutely")
Time frame: 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
answer to the item: "To what extent do you think your loved one feels psychologically distressed at the moment? " (likert scale from 0: "not at all" to 10: "absolutely")
Time frame: 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)
answer to the item "to what extent are you currently experiencing physical pain?" (likert scale from 0: "not at all" to 10: "absolutely")
Time frame: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
exposure to potentially traumatic events
self reported Life Event Checklist for DSM-5 (LEC-5). The total score is 0 to 48. The higher the score, the more the participant reports traumatic events.
Time frame: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
post traumatic stress disorder (PTSD)
PTSD checklist for DSM 5 (PCL-5). The total score (0-80) reflects the severity of the PSTD symptoms, and a cut off of 32 a possible PTSD.
Time frame: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
anxiety symptoms
Generalized Anxiety Disorder (GAD7). The overall score ranges from 0 to 21. Scores of 5, 10 and 15 represent thresholds for mild, moderate and severe anxiety respectively
Time frame: : from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
depressive symptoms
Patient Health Questionnaire (PHQ9). The total score ranges from 0 to 27, with a score of 10 or more indicating moderate depression.
Time frame: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
social support
Social Support Questionnaire SSQ6. Higher SSQ6 scores reflect greater satisfaction with the level of social support.
Time frame: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
difficulties in emotion regulation
Difficulties in Emotion Regulation Scale Short Form (DERS SF). The higher the score, the greater the difficulty of emotional regulation.
Time frame: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
resilience
Resilience Resources Scale (RSS). The total score ranges from 12 to 60. Higher scores reflect greater resilience
Time frame: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
Questions about potential personalized support
Participants will be asked whether they personally feel the need for psychological support to manage their symptoms, and whether they would be willing to engage in such support. If so, they will be asked to specify when they think this support should be offered, and in what form These answers will be collected using open-ended questions.
Time frame: baseline
Socio-demographic factors
age, gender, marital status, socio-professional category, level of education
Time frame: at inclusion (i.e in the month following the announcement of the cancer treatment) - for patients and caregivers
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