University of Normandy, 14000, Caen, France.
UMR 1086 INSERM « ANTICIPE », Centre François Baclesse, 14000, Caen, France.
BMC Cancer. 2019 Jul 8;19(1):673. doi: 10.1186/s12885-019-5836-5.
Despite numerous guidelines, nearly one of two patients with cancer pain remains undertreated, thereby affecting their quality of life. Active patient involvement through Therapeutic Patient Education (TPE) is considered as a relevant strategy to overcoming hurdles in pain management. The aim of the EFFADOL study is to assess the effectiveness of a TPE program in improving cancer pain management.
METHODS/DESIGN: The EFFADOL study is a stepped-wedge randomised controlled trial. A total of 260 cancer patients with unbalanced background pain will be randomised over the institutional level, i.e. stepped-wedge cluster design. Six clusters will be formed, one at the regional level of "Basse-Normandie" for patients receiving the educational approach by health providers already trained to TPE. Then, five additional centers will be gradually included at the national level, making it possible to compare the "conventional" management of pain (before medical staff training to TPE) with the educational approach (after being trained). The main study parameter is pain interference on daily life assessed with the self-administrated and validated Brief Pain Inventory questionnaire. Secondary objectives comprised the evaluation of patients' adherence to pain education program, the description of pain intensity, pain relief, analgesic adherence and pain emotional impact. Educational dimension of the program will be evaluated through the patients' acquisition of knowledge and skills about their pain and treatment as well as their self-efficacy to participate actively in pain management. The patient's feeling of pain changes will be measured. Finally, the satisfaction of participants and educators will be reported. We hypothetise active involvement of patients in TPE will lead to an improved pain management compared to standard care.
Analyzing the impact of a TPE program in cancer pain patients will improve their pain management and quality of life. We expect that the dissemination of our project educational approach through the French territory will be accompanied by long term change in clinical practices with mutual benefit to patients and caregiver-educators.
NCT03297723 , registered: 09/28/2017. Protocol version: Version n°1.1 dated from 2016/09/08.
尽管有许多指南，但仍有近一半的癌症疼痛患者得不到充分治疗，从而影响了他们的生活质量。通过治疗性患者教育（TPE）让患者积极参与被认为是克服疼痛管理障碍的相关策略。EFFADOL 研究的目的是评估 TPE 方案在改善癌症疼痛管理方面的有效性。
方法/设计：EFFADOL 研究是一项阶梯式随机对照试验。共有 260 名背景疼痛不均衡的癌症患者将在机构层面上随机分组，即阶梯式楔形集群设计。将形成六个集群，第一个集群位于“下诺曼底”地区的区域层面，接受已经接受过 TPE 培训的卫生保健提供者提供的教育方法。然后，将在全国层面上逐步纳入另外五个中心，从而可以将“常规”疼痛管理（在医务人员接受 TPE 培训之前）与教育方法（在接受培训之后）进行比较。主要研究参数是使用自我管理和验证的简短疼痛问卷评估日常生活中的疼痛干扰。次要目标包括评估患者对疼痛教育计划的依从性、描述疼痛强度、疼痛缓解、镇痛药物依从性和疼痛的情绪影响。通过患者对自身疼痛和治疗的知识和技能的获取以及他们积极参与疼痛管理的自我效能来评估方案的教育层面。将测量患者疼痛变化的感觉。最后，报告参与者和教育者的满意度。我们假设患者积极参与 TPE 将导致疼痛管理的改善，优于标准护理。
分析 TPE 方案在癌症疼痛患者中的影响将改善他们的疼痛管理和生活质量。我们期望通过法国领土传播我们的项目教育方法，将伴随着临床实践的长期变化，使患者和护理教育者都受益。
NCT03297723，注册时间：2017 年 9 月 28 日。方案版本：第 1.1 版，日期为 2016 年 9 月 8 日。
