Cancer Chronic Pain Predicted by Emotional and Cognitive Status (CanoPEe)
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Clermont-Ferrand, Frankrike, 63003
- CHU clermont-ferrand
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
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cancerpatienter
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Measure of average pain intensity by a numerical rating scale
Tidsram: 7 days before the visit
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Measure of average pain intensity by a numerical rating scale assessed 7 days before the 6 months visit after inclusion of patients.
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7 days before the visit
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Pain assessment by numerical rating scale and DN4
Tidsram: at baseline
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at baseline
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Pain assessment by numerical rating scale and DN4
Tidsram: at 6 months
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at 6 months
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Pain assessment by numerical rating scale and DN4
Tidsram: at 12 months
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at 12 months
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Pain assessment by numerical rating scale and DN4
Tidsram: at 24 months
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at 24 months
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Pain assessment by numerical rating scale and DN4
Tidsram: 2 days after each cancer treatment protocol
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2 days after each cancer treatment protocol
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Evaluation of analgesic consumption
Tidsram: at day 1
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Analgesic consumption is evaluated during all period of the study (name of the specialty, dose, indication, form, administration route, starting date, end date),
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at day 1
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Cognitive assessment by Trail Making Test A and B (TMT)
Tidsram: at baseline
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at baseline
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Cognitive assessment by Trail Making Test A and B (TMT)
Tidsram: at 24 months
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at 24 months
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Cognitive assessment by Trail Making Test A and B (TMT)
Tidsram: at 6 months
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at 6 months
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Cognitive assessment by Trail Making Test A and B (TMT)
Tidsram: at 12 months
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at 12 months
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Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG
Tidsram: at baseline
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at baseline
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Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG
Tidsram: at 24 months
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at 24 months
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Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG
Tidsram: at 12 months
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at 12 months
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Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG
Tidsram: at 6 months
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at 6 months
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Quality of life assessment
Tidsram: at baseline, 6 months, 12 months and 24 months,
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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,
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Social vulnerability assessment by EPICES questionnaire
Tidsram: at baseline, 6 months, 12 months and 24 months
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at baseline, 6 months, 12 months and 24 months
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Anxiety and Depression assessment by HAD scale
Tidsram: at baseline, 6 months, 12 months and 24 months
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at baseline, 6 months, 12 months and 24 months
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Illness perception assessment
Tidsram: at baseline, 6 months, 12 months and 24 months
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Global score ranges from 0 to 200
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at baseline, 6 months, 12 months and 24 months
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Coping strategies assessment by Coping strategies questionnaire (CSQ)
Tidsram: 2 days after each cancer treatment protocol.
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2 days after each cancer treatment protocol.
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Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CHU-0262
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