Information Consultation by a Manipulator Radiotherapy: Impact on Information to Patients Treated With Radiotherapy for Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 308
- 试验地点
- 2
- 主要终点
- EORTC QLQ-INFO25
研究概览
简要总结
The medical teams are increasingly sought by patients to get the most possible information, probably expressed in a different form and thereby supplementing the information already received. Coulter et al. reached similar conclusions in their study of the writings of patient information documents. They point out, moreover, the best adaptation of the patients better informed compared to those with less or no information.
This need for information varies over time. It is present before treatment begins, continues during treatment and persists after treatment. Given the specific features of radiotherapy, the manipulators are important interlocutors to participate in the accompanying caregiver time.
In conclusion, the quality of information delivered to the patient has been poorly evaluated, let alone with validated tools in this area.
The impact of information on the tolerance of the treatment also needs to be confirmed, knowing that an informed patient seems less anxious and better prepared for future treatment.
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
- •Patients with cancer of the head and neck, esophagus, stomach, breast, rectum, anal canal, prostate, lung, bile duct, pancreas or female genital histologically proven
- •Patient being treated by radiotherapy alone or combined with chemotherapy / immunotherapy, exclusive treatment or adjuvant
- •Age over 18 years
排除标准
- •Patient has been treated with radiation to the tumor site
- •Patient with metastatic stage disease
- •Patient targeted for hypofractionated radiotherapy
研究组 & 干预措施
A-Standard Care
standard care
干预措施: Standard care (Other)
B-manipulator consultation radiotherapy added to standard care
manipulator consultation radiotherapy added to standard care
干预措施: manipulator consultation radiotherapy added to standard care (Other)
结局指标
主要结局
EORTC QLQ-INFO25
时间窗: 12 weeks
Assesses the amount of information received by patients using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Information Module (EORTC QLQ-INFO25) before the first radiotherapy session. The Global Information Score will be reported. According to the EORTC scoring manual, raw scores are linearly transformed into a standardized scale ranging from a minimum of 0 to a maximum of 100. Higher values represent a better outcome (a higher level of information received), while lower values represent a worse outcome. Data will be presented as the mean value and standard deviation (SD) for each randomization arm.
次要结局
未报告次要终点