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临床试验/NCT03297723
NCT03297723已完成不适用

Effectiveness of a Patient Therapeutic Education Program in Improving Pain Management

Centre Francois Baclesse16 个研究点 分布在 1 个国家目标入组 167 人开始时间: 2017年12月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
167
试验地点
16
主要终点
the decrease of pain impact on daily life activities based on a decrease of 2 points (on a 0-10 scale) between mean values measured before and after the PEP (at 1 month).

研究概览

简要总结

Pain is one of the most feared and burdensome symptoms experienced by cancer patients. Its prevalence has been estimated by INCa1 in 2012 at 48% in patients undergoing cancer treatment, and unrelieved pain is directly associated with significantly reduced quality of life (QoL)2. A large part of cancer pain undertreatment can be attributed to patient-related barriers. Patient barriers are multifactorial and often result from a lack of knowledge about cancer pain and its self-management. They mainly consist of misconceptions about opioids and their side effects, nonadherence, and reluctance to alert health care providers to unrelieved pain. Patient education enables people with chronic disease to manage their illness, and has been considered in the field of cancer research as an important strategy to achieve optimal pain control.

In Basse-Normandie french region, the "Health Regional Plan, pain aspect" has identified the theme " pain education program " as a priority.

The main endpoint is the decrease of pain interference with daily life (using the Brief Pain Inventory). The experimental group, consisting of cancer pain patients, will benefit from the education program by previously trained health care providers. It will be compared with the control group, consisting with patients whose pain will be conventionally managed before the professional training in therapeutic education.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Patient suffering from a cancer which diagnosis has been established since at least 1 month
  • Patient who suffers from pain related to the pathology or its treatment:
  • receiving an analgesic treatment since at least 1 month
  • moderate to severe pain intensity in the previous week : average pain score greater than 4 (on a 0-10 numerical rating scale), OR pain leading to insomnia OR 4 daily breakthrough pain, which interferes with daily activities
  • Patient with a life expectancy > or = 6 months
  • Health compatible with the PEP requirements (WHO performance scale > or = 2)
  • Patient v 18 years old
  • Patient able to understand, speak and read French
  • Patient without cognitive dysfunctions
  • Patient with a signed informed consent before inclusion in the study

排除标准

  • Primary central nervous system or cerebral metastases
  • Disorders of higher functions documented
  • Evolutionary psychiatric pathology
  • Drug user
  • Abuse of alcohol exceeding WHO recommendations
  • Refusal of participation

结局指标

主要结局

the decrease of pain impact on daily life activities based on a decrease of 2 points (on a 0-10 scale) between mean values measured before and after the PEP (at 1 month).

时间窗: 1 month

次要结局

  • The proportion of patients adhering to the full ETP program (3 workshops),(1 month)

研究者

发起方
Centre Francois Baclesse
申办方类型
Other
责任方
Sponsor

研究点 (16)

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