Cancer Chronic Pain Predicted by Emotional and Cognitive Status

Study Overview
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Brief Summary
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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 ...).

Detailed Description
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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.

Official Title
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Cancer Chronic Pain Predicted by Emotional and Cognitive Status

Conditions
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Chronic Pain, Cancer

Intervention / Treatment
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* Other: chronic pain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Cancer patient with one or more programmed cancer treatment protocols (chemotherapy, surgery, hormone therapy, radiation therapy, targeted therapy, ...) Acceptance to sign the non-opposition form Exclusion Criteria: History of cancer and cancer treatment protocols (chemotherapy, surgery, hormone therapy, radiation therapy, targeted therapy, ...) History and/or presence of primary brain tumors (glioblastoma, meningioma, neurofibroma ...) History of neurological disorders (Parkinson's disease, Alzheimer's disease, dementia, epilepsy, moderate to severe head injury, ...) History of psychiatric disorders (schizophrenia, bipolar disorder, ...) Medical and surgical history incompatible with the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cancer patients<br> | Other: chronic pain<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer treatment protocols, chronic cancer pain, cognitive function, quality of life, anxiety, depression