Cancer Chronic Pain Predicted by Emotional and Cognitive Status (CanoPEe)
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Clermont-Ferrand、フランス、63003
- CHU Clermont-Ferrand
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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がん患者
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Measure of average pain intensity by a numerical rating scale
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pain assessment by numerical rating scale and DN4
時間枠：at baseline
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at baseline
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Pain assessment by numerical rating scale and DN4
時間枠：at 6 months
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at 6 months
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Pain assessment by numerical rating scale and DN4
時間枠：at 12 months
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at 12 months
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Pain assessment by numerical rating scale and DN4
時間枠：at 24 months
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at 24 months
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Pain assessment by numerical rating scale and DN4
時間枠：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
時間枠：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)
時間枠：at baseline
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at baseline
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Cognitive assessment by Trail Making Test A and B (TMT)
時間枠：at 24 months
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at 24 months
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Cognitive assessment by Trail Making Test A and B (TMT)
時間枠：at 6 months
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at 6 months
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Cognitive assessment by Trail Making Test A and B (TMT)
時間枠：at 12 months
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at 12 months
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Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG
時間枠：at baseline
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at baseline
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Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG
時間枠：at 24 months
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at 24 months
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Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG
時間枠：at 12 months
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at 12 months
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Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG
時間枠：at 6 months
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at 6 months
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Quality of life assessment
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：2 days after each cancer treatment protocol.
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2 days after each cancer treatment protocol.
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- CHU-0262
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