Efficacy of the "Consilium" Smartphone App for Detecting Symptoms and Treatment Side Effects in Cancer Patients Depending on Form of Medication Application, Age and Outpatient Characteristics: Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 224
- 试验地点
- 18
- 主要终点
- Level of agreement
研究概览
简要总结
The study investigates the influence of the use of a Smartphone App, on changes in general well-being and the occurrence of symptoms during a tumor therapy. With this documentation, medical professionals should be enabled to judge the influence of symptoms on quality of life during different time periods, between planed visits on site.
详细描述
The study will examine the number, characteristics and intensity of electronically reported symptoms and therapy side effects depending on treatment and characteristics of patients with cancer of breast, colon, prostate, lung and hematological malignancies during a three-month period from the initiation of therapy. This period frequently represents the duration of a therapeutic regimen.
The level of agreement κ between the ECOG/CTCAE ratings by physicians at the time of the regular consultation, and the ratings derived from the daily PROs between consultations, will be analyzed in order to determine the reliability and utility of self-reported electronic symptom monitoring.
The purpose is to evaluate different qualities of symptoms self-reported electronically between consultations with respect to the course of treatment application, out-patient settings, gender and age. In particular, outpatients with frequent (weekly) consultations will be compared to patients with infrequent consultations (3-weekly or less frequent).
The study will also aim to identify the conditions and factors that might increase the likelihood of an unplanned consultation or emergency hospitalization.
In particular, the proposed study design and associated primary and secondary endpoints will enable us to test the following hypotheses:
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
- •Signed Informed Consent Form
- •Women or men aged ≥ 18 years
- •Patients with breast, colon, prostate, lung cancer or hemat. malignancies
- •Initiation or change of therapy for the types of cancer mentioned above
- •German speaking
- •Personal smartphone with iOS or Android system
排除标准
- •Patients whose compliance must be questioned, e.g. due to a psychological disorders or private life situation
- •Patients with insufficient knowledge of smartphone use.
结局指标
主要结局
Level of agreement
时间窗: 12 weeks of treatment
Level of agreement κ with respect to categories of common toxicity criteria (ECOG/CTCAE) categories between ePRO recording and the treating physician at time of consultation
次要结局
- ePRO and therapy side effects(12 weeks of treatment)
- Usability and usefulness of smartphone app(12 weeks of treatment)
- Rating of different qualities of electronically reported symptoms in out-patient settings(12 weeks of treatment)
- Unplanned consultations(12 weeks of treatment)
- Hospital days(12 weeks of treatment)
- Patient characteristics for discontinued use of mobile monitoring(12 weeks of treatment)