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临床试验/NCT02777697
NCT02777697已完成不适用

Cancer Chronic Pain Predicted by Emotional and Cognitive Status

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
89
试验地点
1
主要终点
Measure of average pain intensity by a numerical rating scale

研究概览

简要总结

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 ...).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Measure of average pain intensity by a numerical rating scale

时间窗: 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.

次要结局

  • Evaluation of analgesic consumption(at day 1)
  • 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.)
  • Cognitive assessment by Trail Making Test A and B (TMT)(at 12 months)
  • Quality of life assessment(at baseline, 6 months, 12 months and 24 months,)
  • Illness perception assessment(at baseline, 6 months, 12 months and 24 months)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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