NCT06117696尚未招募不适用
Optimizing the Announcement of Advanced or Metastatic Prostate Cancer Using Animated Videos (CartDiag PROSTATE)
Direction Centrale du Service de Santé des Armées3 个研究点 分布在 2 个国家目标入组 90 人开始时间: 2024年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- EORTC QLQ-INFO25 score
研究概览
简要总结
In hospitals, the standard prostate cancer announcement system is based on oral and written information. To improve this system, we have developed animated videos that retrace the patient's care path.
This is an exploratory, controlled, before-and-after, multicenter study designed to assess the effect of a standard announcement system reinforced by animated videos on patients' level of understanding of prostate cancer diagnosis and treatment. Patients' perception of information will be assessed using the EORTC QLQ-INFO25 questionnaire.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 否
入选标准
- •Collection of the patient's non-opposition prior to participation in the study.
- •Patient aged ≥ 18 years at inclusion.
- •Patient with newly diagnosed advanced or metastatic prostate cancer.
- •Patients due to start systemic therapy.
- •Patients undergoing consultation.
- •Patient affiliated to a social security scheme.
- •Patient capable, according to the physician-investigator, of communicating well, understanding and complying with the requirements of the study.
- •Patient with a smartphone or computer to review the video at home.
排除标准
- •Patient related to any member of the study staff or having a close relationship or conflict of interest with the sponsor.
- •Patient to receive only local treatment.
- •Patient who does not understand French.
- •Clinical follow-up impossible for psychological, family, social or geographical reasons.
- •Vulnerable patient: deprived of liberty by judicial or administrative decision, adult subject to legal protection or unable to express non-opposition.
结局指标
主要结局
EORTC QLQ-INFO25 score
时间窗: Through study completion (30 days)
overall score of the EORTC QLQ-INFO25 questionnaire at D0 and D30 completed by the patient in each group
次要结局
- EORTC QLQ-INFO25 score differences(Through study completion (30 days))
研究者
研究点 (3)
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