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临床试验/NCT03868176
NCT03868176Unknown不适用

Phase II, Open-label, Randomized, Non-comparative Study Evaluating the Impact of Short Message Service (SMS) on Compliance With Surveillance of Patients With Germ-cell Tumors. (TEXTIS Study)

Centre Hospitalier Universitaire de Besancon1 个研究点 分布在 1 个国家目标入组 235 人开始时间: 2019年2月28日最近更新:
适应症

试验速览

阶段
不适用
入组人数
235
试验地点
1
主要终点
Rate of patients who report optimal compliance to surveillance

研究概览

简要总结

This study will evaluate the impact of Short Message Service (SMS) on compliance with surveillance of patients with germ-cell tumors. Patients will be randomized in a 2:1 ratio to get 2 groups : (1) patients will receive reminder SMS before appointment detailing the date of consultation and exams to be performed before; (2) standard of care without SMS.

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
Male
接受健康志愿者

入选标准

  • Patient with germ cell tumor.
  • Patient with a mobile phone.
  • Patient on surveillance.

排除标准

  • Testicular cancer without germ cell component.
  • Prior history of other malignancy except for: cutaneous cancers excluding melanoma, superficial bladder tumor, localized prostate cancer with undetectable PSA.
  • Cognitive condition that would preclude patient's understanding and completion of study procedures.

结局指标

主要结局

Rate of patients who report optimal compliance to surveillance

时间窗: 1 year

Optimal compliance is defined according to the following 2 parameters: * The patient comes to all the appointments, on the expected day, AND * With all the biological and imaging exams previously scheduled by the physician.

次要结局

  • Patient satisfaction of sending SMS, in experimental arm(1 year)
  • Rate of patients who report intermediate compliance to surveillance(1 year)
  • Radiological recurrence rate(1 year)
  • Rate of patients who report a non compliance to surveillance(1 year)
  • biological recurrence rate(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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