DECLIC Patient Education Program : Assessment Through a Population Health Intervention Research Approach (LE DECLIC EPRI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 246
- 试验地点
- 5
- 主要终点
- Effectiveness of LE DECLIC EPRI intervention on the pain interference with the daily life
研究概览
简要总结
Cancer pain is a frequent symptom, reported by 20 to 70% of patients in any stage of the cancer disease : 60 to 70% in the advanced stage of the disease and 20 to 40% among the survivors. Among patients who report pain, 40% report undertreated pain. Strengthening Pain management in cancer is a specific objective of the French Cancer Plan. Providing patient education for cancer pain management is recommended since small to moderate efficacy of patient education on pain intensity and interference was found in all meta-analysis. An effect size comparable with some analgesic agents. However, recommendations suggest improvement in order to increase effectiveness and population reach of those interventions. The DECLIC EPRI intervention aim at addressing all the issues raised by patient education for cancer pain management. It was developed according to the framework of Michie's Behavior change wheel theory.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged over
- •Followed in the participant comprehensive cancer center.
- •All cancer types, location and stage.
- •Patient under any anticancer treatment (including hormonal therapy) or patient has stopped his treatment (including hormonal therapy) maximum 2 years before inclusion.
- •Patient experiencing cancer pain and/or his treatments for 3 months or more.
- •All previous and concomitant treatments are accepted.
- •Participation to another clinical trial is accepted.
- •Patient has accepted to participate to the study and signed informed consent form or his legal representative.
- •Patient affiliated to the social security healthcare.
排除标准
- •Cognitive impairment preventing to understand the patient education program.
- •Language barrier preventing to understand the patient education program.
- •Physical impairment preventing patient to attend to the patient education program.
研究组 & 干预措施
Experimental group
Clusters will be proposed LE DECLIC EPRI intervention, which is a complex intervention, associating 3 components,:
A. DECLIC program set up in the centers, open to concerned patients.
B. 3 training sessions :
- one public of primary care physicians in order to give them the opportunity to be involved in the medical care in charge of the patient suffering from cancer pain.
- one public of cancer physicians, leaders of opinions in each cancer centers participating to the study and one public of health professionals in order to train them to be educators (team building).
- for healthcare professionals in order to train them as educators in this program.
C. The collaboration of one primary care network, specialized in pain management, in order to reinforce the patient care pathway.
干预措施: Experimental group (Other)
Standard group
Standard follow-up patient related to pain. Specific to each center : with or without existing local ETP program (standard care).
干预措施: standrad group (Other)
结局指标
主要结局
Effectiveness of LE DECLIC EPRI intervention on the pain interference with the daily life
时间窗: 6 months
Brief pain Inventory BPI Questionnaire
次要结局
- Effectiveness of the intervention on patients value.(6 months)
- Efficiency of the intervention.(6 months)
- The organizational effectiveness of the intervention.(6 months)
- Effect of patient's caracteristics on the intervention effectiveness and participation.(6 months)
- Effectiveness of the intervention on other clinical outcomes(6 months)
- Educational effectiveness of the intervention.(6 months)
- Implementation of the intervention(48 months)
- Interaction between the contexts and the intervention effectiveness.(48 months)
- Mechanisms of action of the intervention.(48 months)