Development and Evaluation of a Therapeutic Education Intervention Focused on the Accession of Patients Treated With Hormonal Therapy in the Management of Breast Cancer: PEPs Hormonotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 352
- 试验地点
- 5
- 主要终点
- measuring changes in patient compliance
研究概览
简要总结
The purpose of this study is to evaluate the feasibility and the effectiveness of a patient education program on patients' adherence to adjuvant hormone therapy (anti-estrogen or aromatase inhibitors) for breast cancer, in collaboration with teams of sociologists, patient education and medical oncologists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged over 18
- •History of breast cancer
- •Medical prescription for an adjuvant hormonal treatment (anti-estrogens and / or aromatase inhibitors) as monotherapy or in combination with other treatments
- •Affiliated to a social security scheme
排除标准
- •Refusal to participate, patient protected by guardianship.
- •Patient unable to understand the study or unable to follow the education sessions.
- •Patient with documented cognitive or psychiatric history.
- •Geographical remotness (more than 100 Kms).
研究组 & 干预措施
control arm
Patients follow the classic support prescription of hormonotherapy
therapeutic education program
Patients follow the 4 sessions of PEP hormonotherapy. The therapeutic education prgram is led by a trained educational team, inside a prevention center : Hygée centre.
干预措施: therapeutic education program (Behavioral)
结局指标
主要结局
measuring changes in patient compliance
时间窗: 12 months
compliance measure with prescription refillment and questionnaire. At the inclusion and at the end of the study
次要结局
- patients' quality of life assessment(12 months)
- Measuring the level of knowledge of patients related to the disease, the treatment and its side effects(12 months)
- measure of the patients' competence in the management of treatment side effects(12 months)
- Measuring the level of patient anxiety(12 months)
- Measuring the level of confidence of patients related to their treatment(12 months)