Evaluating the Effectiveness of Typology-based Coaching on Patients' Therapy Management (TYPER)
2026年7月13日 更新者：Institut fuer Frauengesundheit
A Randomized Controlled Study Evaluating the Effectiveness of Typology-based Coaching on Therapy Management for Patients With HRpos/HER2neg Early Breast Cancer Under Adjuvant Treatment With Ribociclib
The goal of this clinical trial is to evaluate the effect of patient education and patient typology-based coaching on therapy persistence in breast cancer patients taking ribociclib.
Researchers will compare the time to permanent treatment discontinuation of patients receiving personalized coaching to the time to permanent treatment discontinuation of patients who only receive standard of care education and counselling, to see if adherence to treatment can be improved by personalized patient coaching.
研究概览
研究类型
介入性
注册 (估计的)
548
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Institut für Frauengesundheit GmbH
- 电话号码：+49 9131 91880613
- 邮箱：typer@ifg-erlangen.de
学习地点
-
-
Bavaria
-
Augsburg、Bavaria、德国、86156
- 招聘中
- Department of Gynecology and Obstetrics, Universitätsklinikum Augsburg
-
接触：
- Nina Ditsch, Prof. Dr. med.
- 电话号码：+49 821 400165809
- 邮箱：nina.ditsch@uk-augsburg.de
-
Erlangen、Bavaria、德国、91054
- 招聘中
- Department of Obstetrics and Gynecology, Uniklinikum Erlangen
-
接触：
- Peter A. Fasching, Prof. Dr. med.
- 电话号码：+49 9131 8533572
- 邮箱：fk-studienzentrale@uk-erlangen.de
-
Hösbach、Bavaria、德国、63768
- 招聘中
- MVZ Klinikum Aschaffenburg, Zweigstelle Hänatologie und Onkologie
-
接触：
- Manfred Welslau, Dr. med.
- 电话号码：+49 6021 4527391
- 邮箱：manfred.welslau@mvz-klinikum-ab.de
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Participant provides written informed consent prior to the beginning of trial-specific procedures.
- Patients must be aged ≥18 years on the day of signing informed consent.
- Participant has histologically confirmed primary invasive adenocarcinoma of the breast.
- Participant has a histologically and/or cytologically confirmed diagnosis of ER-positive and/or progesterone receptor-positive breast cancer based on the most recently analyzed tissue sample tested by a local laboratory.
- Participant has HER2neg breast cancer defined as a negative ISH test or an IHC status of 0, 1+, or 2+. If the IHC is 2+, a negative ISH (e.g., FISH, CISH, SISH, or DISH) test is required by local laboratory testing and based on the most recently analyzed tissue sample.
- Indication for treatment with ribociclib in combination with an aromatase inhibitor for early breast cancer according to the valid SmPC.
- Participant has adequate organ function amenable for treatment with ribociclib as assessed by a local laboratory.
- Female participants of childbearing potential must have had a hysterectomy or be willing to use highly effective methods of contraception and have a confirmed negative pregnancy test as assessed by local in-house standard.
- Participant is willing and able to comply with scheduled visits, treatment plans, and other trial procedures.
Exclusion Criteria:
- Patients with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.
- Patients with serious preexisting medical condition(s) that would preclude participation in this study.
- Women who are pregnant or lactating.
- Patients with active bacterial infections (requiring IV antibiotics at time of initiating study treatment), fungal infections, or detectable viral infections (e.g., known human immunodeficiency virus positivity or known active hepatitis B or C, such as hepatitis B surface antigen-positive]).
- Patients with a personal history in the past 5 years of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
- Patients with contraindications against ribociclib according to the current SmPC.
- Patients with hypersensitivity to active substance of ribociclib, peanuts, soya or one of the other ingredients
- Patients who are not eligible for the trial due to severe comorbidities other than those mentioned above or unavailability according to the treating physician.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Typology-based coaching
Personalized therapy coaching based on patient typology
|
Standardized patient coaching based on the Multinational Association of Supportive Care in Cancer (MASCC) Oral Agent Teaching Tool© (MOATT)
|
|
无干预：Standard of care patient counselling
Standard of care therapy education and counselling
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to discontinuation
大体时间：From baseline up to end of study (max. 5 years)
|
Time to permanent discontinuation of ribociclib therapy
|
From baseline up to end of study (max. 5 years)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Ribociclib persistence rate
大体时间：At 6, 12 and 36 months after therapy start
|
Ribociclib persistence rate (defined as ongoing ribociclib therapy)
|
At 6, 12 and 36 months after therapy start
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Manfred Welslau, Dr. med.、MVZ Klinikum Aschaffenburg, Zweigstelle Hänatologie und Onkologie
- 首席研究员：Nina Ditsch, Prof. Dr. med.、Department of Gynecology and Obstetrics, Universitätsklinikum Augsburg
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年11月4日
初级完成 (估计的)
2030年6月1日
研究完成 (估计的)
2030年6月1日
研究注册日期
首次提交
2026年7月13日
首先提交符合 QC 标准的
2026年7月13日
首次发布 (实际的)
2026年7月16日
研究记录更新
最后更新发布 (实际的)
2026年7月16日
上次提交的符合 QC 标准的更新
2026年7月13日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- IFG-01-2024
- 2024-520290-12-00 (克蒂斯)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.