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| Name | Class |
|---|---|
| Centre Oscar Lambret, Lille, France | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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") | 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 |
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Inclusion Criteria:
Part 1. Diagnosis of Ca-PTS
Patient inclusion criteria:
Inclusion criteria for caregivers:
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:
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:
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:
Exclusion Criteria:
Part 1. Diagnosis of Ca-PTS
Non inclusion criteria for patients :
Non-inclusion criteria for caregivers:
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
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centre oscar lambret
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Oscar Lambret | Recruiting | Lille | Nord | 59000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25642841 | Background | 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. | |
| 27723815 |
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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. |
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") |
| 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") | 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") | 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") | 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. | 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. | 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 | : 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. | 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. | 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. | 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 | 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. | baseline |
| Socio-demographic factors | age, gender, marital status, socio-professional category, level of education | at inclusion (i.e in the month following the announcement of the cancer treatment) - for patients and caregivers |
| Centre Oscar Lambret | Recruiting | Lille | Nord | 5900 | France |
|
| 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. |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D014947 | Wounds and Injuries |
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