Cancer Chronic Pain Predicted by Emotional and Cognitive Status
- Conditions
- CancerChronic Pain
- Registration Number
- NCT02777697
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 89
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Measure of average pain intensity by a numerical rating scale 7 days before the visit Measure of average pain intensity by a numerical rating scale assessed 7 days before the 6 months visit after inclusion of patients.
- Secondary Outcome Measures
Name Time Method Evaluation of analgesic consumption at day 1 Analgesic consumption is evaluated during all period of the study (name of the specialty, dose, indication, form, administration route, starting date, end date),
Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG at 6 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 Pain assessment by numerical rating scale and DN4 2 days after each cancer treatment protocol Coping strategies assessment by Coping strategies questionnaire (CSQ) 2 days after each cancer treatment protocol. Quality of life assessment at baseline, 6 months, 12 months and 24 months, 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 126Illness perception assessment at baseline, 6 months, 12 months and 24 months Global score ranges from 0 to 200
Cognitive assessment by Trail Making Test A and B (TMT) at 12 months
Trial Locations
- Locations (1)
CHU Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
CHU Clermont-Ferrand🇫🇷Clermont-Ferrand, France