The Possible Influence of Different Follow-up Modalities on Overall Survival in Ovarian Cancer: A Multicenter Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- Overall survival three years after end of therapy
研究概览
简要总结
The study is designed as an observational cohort study, aiming to evaluate, whether a structured recording of symptoms by a mobile app contributes insight in the follow-up modalities of ovarian cancer patients.
详细描述
The observational study will examine different follow-up modalities for ovarian cancer patients with the ultimate goal of improving follow-up strategies for an improved well-being and better clinical outcomes. The primary objective is to quantify the effects of conservative clinical diagnostics by collecting symptoms via ePRO in addition to intensive diagnostics (CA-125 testing, imaging diagnostics) during follow-up, on survival, time to clinical recurrence and well-being.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged ≥ 18 years
- •Between diagnosis and the first follow-up visit after the end of their antineoplastic treatment (systemic therapy or surgical treatment) for ovarian cancer.
- •German, English, French, or Italian speaking
- •Personal smartphone (iOS or Android system); one of the latest three main versions
排除标准
- •Patients whose compliance must be questioned, e.g. due to a psychiatric disorder, private life situation or insufficient knowledge on smartphone use and do not have a suitable caregiver to assist them with symptom reporting.
结局指标
主要结局
Overall survival three years after end of therapy
时间窗: 3 years
Overall survival three years after the end of primary therapy / start of follow-up
次要结局
- Symptoms that led to further diagnostic measures and possibly the detection of tumor relapse(3 years)
- Time to Recurrence(3 years)
- Total number of tumor relapses(3 years)
- Number and type of unplanned hospitalizations and emergencies.(3 years)
- Amount and frequency of patient data entries(3 years)
- Platinum-sensitivity and the patients' platinum free interval (PFI)(3 years)
- Well-being(3 years)