Interest of a Weekly Consultation by a Medical Electro Radiology Manipulator (MERM) in Addition to the Follow-up by the Radiotherapist to Improve the Collection of Radio-induced Toxicities in Patients Undergoing Proton Therapy: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Proportion of patients with at least one toxicity requiring intervention
研究概览
简要总结
To our knowledge, the investigators have not found any scientific article dealing with cooperation between radiation oncologists and medical radiation technologists in the context of monitoring patients undergoing radiotherapy. Cooperation protocols between health professionals are in progress but concern mainly technical procedures (ultrasound, laserthermal sessions).
This study aims to evaluate whether MERMs, after training by physicians, can monitor clinical signs (for usual well-described toxicities) during treatment via a dedicated consultation.
This approach participates in the development of new professions and cooperation protocols between health professionals. This mission of accompaniment on a dedicated time would make it possible to develop the caring role of the medical electroradiology manipulator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Patient > 18 years;
- •Patient with malignant or benign brain or upper aerodigestive tract (ADT) tumor candidate for proton therapy;
- •WHO score < 2
- •Mastery of the French language;
- •Patient affiliated with a social security system;
- •Signature of informed consent prior to any specific procedure related to the study.
排除标准
- •Patient with another cancer previously treated with radiation therapy;
- •Simultaneous participation in a therapeutic clinical trial;
- •Patient deprived of liberty or under guardianship;
- •Any associated medical or psychological condition that may compromise the patient's ability to participate in the study
- •Patient unable to undergo trial monitoring for geographical, social or psychopathological reasons.
结局指标
主要结局
Proportion of patients with at least one toxicity requiring intervention
时间窗: 3 weeks
次要结局
- Number of toxicities detected(3 weeks)