Assessment of the Implementation of a Therapeutic Educational Intervention Affecting Adherence to Oral Chemotherapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 6
- 主要终点
- percentage of affected population
研究概览
简要总结
Therapeutic education is an effective way to support the prescription of oral chemotherapy in oncology. It aims to increase adherence to treatment, to better control the side effects and reduce unplanned readmissions. The three major oncology institutions in the Rhône-Alpes region (Hospices Civils de Lyon, the Centre Léon Bérard Cancer Institute and Lucien Neuwirth) decided to collaborate on a project to implement an adapted Therapeutic Education Program context of each of these institutions.
The objective of this study is to evaluate the implementation of the intervention in the 3 participating centers, over 1 year:
- Assess the achievement of the target population
- Evaluate the adaptation of intervention in context
- Evaluate the effectiveness of the intervention (impact): effectiveness in real life, identification of interactions with the environment linked to the center, identification of unintended effects of the intervention.
- Assessing the sustainability of the intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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 care in medical oncology services of the Cancer Institute of Lucien Neuwirth, the Lyon-Sud hospital and the Centre Léon Bérard:
- •Age over 18 years
- •Introducing an active cancer (local extension, locoregional or metastatic)
- •Oral chemotherapy as monotherapy or in combination with other treatments, initiated or in progress
排除标准
- •Refusal to participate, protected adult patient under guardianship.
- •Patient disability to understand the course of the study, the Therapeutic education program, or failure to follow the educational sessions.
- •Patient with documented history of cognitive or psychiatric disorders.
- •Patient on adjuvant therapy or hormone therapy for prostate cancer
研究组 & 干预措施
therapeutic education program
therapeutic education program which aims is to improve the adherence to the treatment and management of adverse effects of this treatment in patients taking an oral chemotherapy for active cancer
干预措施: therapeutic education program (Behavioral)
结局指标
主要结局
percentage of affected population
时间窗: 3 months
Level of acquisition of knowledge
时间窗: 3 months
Questionnaire composed of numerous questions dealing with patient's knowledge about his/her disease, treatment and treatment's side effects . Answers are quoted in Yes/No and a global scoring is made with all answers. Final measure is a percentage of good answers.
Anxiety and Depression
时间窗: 3 months
measured with the Hospital Anxiety Depression Scale (Zigmond \& Snaith, 1983 ), wich gives separated results about the level of anxiety and of depression according to the level of scoring to a set of 14 questions. Questions are rated from 0-3, and the anxiety and depression subscale scores range from 0-21. The cutoff for each subscale is eight.
Quality of Life Questionnaire
时间窗: 3 months
Morisky Measurement Adherence Scale
时间窗: 3 months
次要结局
未报告次要终点