Primäres Hormon-Sensitives Mammakarzinom: Bedarfsgerechte Optimierung Der Versorgung Durch Eine Patientenzentrierte, Digitale Anwendung
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Quality of Life (QOL)
研究概览
简要总结
The investigators designed a prospective, 2-armed, cluster-randomized multicenter clinical trial on the effect of a by a digital application triggered intervention on quality of life and therapy-adherence among breast cancer patients, compared to standard of care.
详细描述
With validated questionnaires, patient reported outcome monitoring data on quality of life, distress and therapy-adherence are collected. In case of pathologic values, the attending breast center gets advised to intervene according to individual requirements.
For women with breast cancer, disease and therapy come along with loss of quality of life. Therapy and its side effects often result in unauthorized discontinuation of therapy by patients. Non-adherence rates to endocrine therapy (ET) range from 31% to 73%. These patients have a poorer prognosis due to recurrence, progression and cancer deaths. Positive effects to increase therapy-adherence were shown for bidirectional communication. Furthermore the use of apps with reminder functions can increase adherence to cancer therapy. The intention within this project is to improve care of patients with primary breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •primary, hormone-sensitive breast cancer
- •indication for adjuvant endocrine therapy (aromatase-inhibitor, tamoxifen, GnRH-analogue allone or in combination with tamoxifen/ aromatas inhibitor; combination of endocrine therapy with CDK 4/6-inhibitor/ antibody therapy/ radiotherapy)
- •start of endocrine therapy <= 3 months ago
- •patients with public health ensurance
- •patients who are legally competent and able to understand and follow instructions of the study staff
- •present informed consent
排除标准
- •no use of internet or digital applications
- •advanced, metastatic breast cancer
- •simultaneous serious disease
- •life expectancy < 2 years
结局指标
主要结局
Quality of Life (QOL)
时间窗: 24 Months
Change in EORTC QLQ-C30 subscale
次要结局
- Adverse effect of therapy(24 Months)
- Assessment of new digital form of care(24 Months)
- Efficiency (QALY)(24 Months)
- Adherence(24 Months)
- Progression free survival(24 Months)
- Overal survival(24 Months)
- Patient Satisfaction(6, 24 Months)
- Number of Interventions(24 Months)
- Mental health(24 Months)
- Disease-specific costs(24 Months)
- Effectiveness (QOL)(24 Months)
- Stakeholder perspective(12, 24 Months)
- Total cost(24 Months)
- Quality of Life (QOL)(6, 12, 18 Months)