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The aim of this study is to investigate the predictive dimension of cognitive-emotional status of cancer patients on the chronic pain development 6 months after different cancer treatment protocol (surgery, chemotherapy, radiotherapy, hormone therapy, targeted therapy ...).
This is an observational, longitudinal and multicenter study assessing in cancer patients the link between the cognitive-emotional status and the development of chronic pain.
Cognition, anxiety, depression, quality of life, social vulnerability, cancer perception, pain and analgesic consumption are assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cancer patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chronic pain | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure of average pain intensity by a numerical rating scale | Measure of average pain intensity by a numerical rating scale assessed 7 days before the 6 months visit after inclusion of patients. | 7 days before the visit |
| Measure | Description | Time Frame |
|---|---|---|
| Pain assessment by numerical rating scale and DN4 | at baseline | |
| Pain assessment by numerical rating scale and DN4 | at 6 months | |
| Pain assessment by numerical rating scale and DN4 |
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Inclusion Criteria:
Exclusion Criteria:
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cancer patients
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| Name | Affiliation | Role |
|---|---|---|
| Gisèle PICKERING | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D009369 | Neoplasms |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| at 12 months |
| Pain assessment by numerical rating scale and DN4 | at 24 months |
| Pain assessment by numerical rating scale and DN4 | 2 days after each cancer treatment protocol |
| Evaluation of analgesic consumption | Analgesic consumption is evaluated during all period of the study (name of the specialty, dose, indication, form, administration route, starting date, end date), | at day 1 |
| Cognitive assessment by Trail Making Test A and B (TMT) | at baseline |
| Cognitive assessment by Trail Making Test A and B (TMT) | at 24 months |
| Cognitive assessment by Trail Making Test A and B (TMT) | at 6 months |
| Cognitive assessment by Trail Making Test A and B (TMT) | at 12 months |
| Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG | at baseline |
| Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG | at 24 months |
| Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG | at 12 months |
| Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG | at 6 months |
| Quality of life assessment | Quality of life assessment by: - The European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), at baseline, 6 months, 12 months and 24 months. This questionnaire assesses the quality of life of cancer patients. It is divided in 9 subscales consisting of several items: 5 subscales measuring functional status (physical, role, social, emotional, cognitive), three subscales measuring symptoms (fatigue, pain, nausea and vomiting) and a global subscale of quality of life and health. Finally, six items/isolated symptoms, covering cancer symptoms and frequent side effects of cancer therapies (e.g. loss of appetite) are also included in the EORTC QLQ-C30. The EORTC QLQ-C30 Score ranges from 0 to 126 | at baseline, 6 months, 12 months and 24 months, |
| Social vulnerability assessment by EPICES questionnaire | at baseline, 6 months, 12 months and 24 months |
| Anxiety and Depression assessment by HAD scale | at baseline, 6 months, 12 months and 24 months |
| Illness perception assessment | Global score ranges from 0 to 200 | at baseline, 6 months, 12 months and 24 months |
| Coping strategies assessment by Coping strategies questionnaire (CSQ) | 2 days after each cancer treatment protocol. |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |