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临床试验/NCT04142476
NCT04142476终止不适用

Evaluation of the Impact of a Pharmaceutical Interview on the Adherence to Hormonotherapy in Women With Breast Cancer

Centre Georges Francois Leclerc2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2019年6月25日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
105
试验地点
2
主要终点
Patient compliance

研究概览

简要总结

Breast cancer is the first cancer in women and 60% of new cases occurring in women 50 to 74 years old. With about 50,000 new cases, it is the second cancer the most serious cancers. In the therapeutic strategy, hormone therapy takes pride of place by allowing a significant reduction in the recurrence rate.

For the hormonotherapy be effective, patient compliance should be optimal during treatment. Different factors or barriers may lead to a lack of adherence, such as the occurrence of adverse effects, treatment fatigue, a difficult relationship with the health care team, beliefs about success or the need for treatment.

In order to facilitate the compliance of hormonoherapy treatment by patients, it is important to include different health professionals such as pharmacists.

详细描述

Hormonotherapy adherence to breast cancer patients could be improved by :

  • the use of electronic pill dispensers since the first prescription to visualize the level of compliance of each patient and study with her the various factors that can limit it.
  • motivational, semi-directed and scheduled drug interviews at regular intervals throughout the study over a period of 18 months to visualize the compliance rate (ratio of the number of tablets taken by the patient on the number of tablets to be taken theoretically over the period), to evaluate the presence or absence of iatrogenesis specific to hormone therapy and to ensure adequate medical follow-up.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

入选标准

  • Woman, over 18 years old.
  • With non-metastatic breast cancer.
  • Treated by hormone therapy, regardless of the molecule (cancer RH positive).
  • In primary prescription of hormone therapy.
  • First prescription by a medical oncologist, surgeon or radiation therapist from the CGFL.
  • Pharmacy of the patient located in the perimeter defined in the context of the study (Residents in the Burgundy region between a triangle delimited by the towns of Chatillon sur Seine, Dole and Chalon sur Saone.
  • Woman who received information about the study and gave her written consent.
  • Affiliation to a social security scheme.
  • Participant Agreement of the referent city pharmacy of the patient.

排除标准

  • Metastatic patient.
  • Patient participating in another epidemiological or clinical study of adherence and / or hormone therapy.
  • Patient under guardianship, curatorship or safeguard of justice.
  • Patient with severe psychiatric disorders or who does not speak the French language
  • Refusal to participate in the study.
  • Refusal of participation of the referent city pharmacy of the patient.

结局指标

主要结局

Patient compliance

时间窗: 18 months

data from electronic pillboxes

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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