A Randomized, Controlled Study of Standardized Patient Coaching Versus Patient Management According to Local Practice for Patients With Hormone Receptor Positive HER2 Negative Metastatic Breast Cancer Treated With Abemaciclib
试验速览
- 阶段
- 不适用
- 入组人数
- 212
- 主要终点
- (Potential) difference in persistence rate after 24 weeks of Abemaciclib therapy in both study arms.
研究概览
简要总结
The aim of the IMPACT - Implementing Patients' competence in oral breast cancer therapy - study is to evaluate the effectiveness of a standardized patient education and coaching and optional eMBSR for therapy management provided by specially trained oncology nurses regarding persistence rate, side effects management and unplanned therapy interruptions in outpatient oncology care for patients under Abemaciclib treatment.
详细描述
Breast cancer therapy has advanced by far over the last decade. Introduction of novel therapies as well as the introduction of mammography screening are thought to have reduced mortality over the last decade. More women are treated on an individual basis, trying to avoid toxic and non-effective therapies.
However, every year about 18.000 women are diagnosed with metastastic breast cancer in Germany. Breast cancer remains one of the main reasons for deaths among women and is the main reason for death due to cancer in younger women.
Once a tumor is metastasized, well balanced treatment decisions have to be made to take both into consideration, a high chance of tumor control and a low risk for side effects. Especially in the metastatic setting symptom control and quality of life need to be in the focus of the therapy and patient care.
Modern anticancer strategies are designed against specific molecular targets with the goal of sparing normal, non-neoplastic tissues. Choosing specific molecular targets, however, is problematic. CDK4/6 (Cyclin dependent kinase 4 and 6) are important candidate targets for therapeutic intervention.
Traditionally, anticancer therapy has been dominated by intravenous drug therapy. However, oral agents, like CDK4/6 inhibitors, provide an attractive approach to this kind of treatment and use of oral treatments is increasing. Currently, there are three CDK4/6 inhibitors that have reached clinical practice in the management of ER+ HER2- advanced disease. One of them is Ademaciclib which is approved in the US since September 2017 for "adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient's hormones".
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult breast cancer patients (age ≥18 years).
- •Patients with HR+, HER2- advanced or metastatic breast cancer proven by clinical measures (i. e. standard imaging) whose disease has progressed after hormonal therapy in combination with fulvestrant, or alone in women whose disease has progressed after hormone therapy and prior chemotherapy (advanced disease must not be amenable to resection with curative intent).
- •Patients treated with Abemaciclib according to the SmPC and each center´s medical practice.
- •Informed consent prior to onset of documentation.
排除标准
- •Patients with serious preexisting medical condition(s) that would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
- •Females who are pregnant or lactating.
- •Patients with active bacterial infections (requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infections, or detectable viral infections (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive]. Screening is not required for enrollment.
- •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 Abemaciclib according to respective SmPC´s.
- •Patients who are not eligible for observation due to severe comorbidities other then mentioned above or unavailability according to the treating physician.
结局指标
主要结局
(Potential) difference in persistence rate after 24 weeks of Abemaciclib therapy in both study arms.
时间窗: 24 weeks
The primary objective of this study is to evaluate both study arms regarding the (potential) effect of patient management according to local routine versus continuous standardized patient education and coaching using the MOATT on persistence rate within the first 24 weeks of Abemaciclib treatment.
次要结局
- Patient decided interruptions(24 weeks)
- To assess patient reported self-efficacy: patient diary(24 weeks)
- To assess patient reported side-effects.(24 weeks)
- To assess patient reported therapy related knowledge.(24 weeks)
- Efficacy between the two study arms at week 24 in routine clinical practice as assessed by Overall survival rate (OS).(24 weeks)
- Patient distress assessed via distress thermometer.(24 weeks)
- Incidence of therapy interruptions.(24 weeks)
- Quality of life assessed by the FACT-B (Version 4.0) questionnaires.(24 weeks)
- Duration of therapy interruptions.(24 weeks)
- Efficacy between the two study arms at week 24 in routine clinical practice as assessed by Progression free survival rate (PFS).(24 weeks)
- eMSBR(24 weeks)
- Safety and tolerability of Abemaciclib treatment: NCI Common Toxicity Criteria Version 5.0(24 weeks)
- To assess patient reported health related stress.(24 weeks)