跳至主要内容
临床试验/NCT05910229
NCT05910229已完成不适用

Interest of a Telephone Paramedical Support Prior to the Radiotherapy Simulation Scanner to Ensure the Realization of Specific Recommendations for the Management of Patients with Prostate Cancer.

Groupe Hospitalier de Bretagne Sud2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年11月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
2
主要终点
Assess the value of a telephone call in terms of compliance recommendations for preparation (empty rectum and full bladder) necessary to perform the CT scanner simulation in the management of patients with prostate cancer.

研究概览

简要总结

The goal of this clinical trial is to evaluate the impact of a phone call before the simulation CT scan in management of care of patients with prostate cancer.

详细描述

After being informed about the study, all patients who have given written informed consent and who met eligibility requirement will be randomized in a simple blind manner ( investigator) in a 1:1 ration.

The main question it aims to answer is : Does a phone call before the simulation CT scan has an effectiveness on patients compliance of the recommendations and therefore on obtaining quality images.

There is no additional risk of patients involvement.

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
Double (Care Provider, Investigator)

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 coming for prostate cancer treatment with or without lymph node irradiation
  • Minimum of 48 hours between the onco radiotherapist and the CT scan
  • Signed a written informed consent form
  • Affiliated to the social security system

排除标准

  • Patient not understanding French
  • Patient not reachable by phone
  • Individual of full age deprived of liberty or placed under a legal protection measure

研究组 & 干预措施

Patient with standard care

No Intervention

Consultation with the onco radiotherapeutic and submission of the recommendations to follow before the simulation CT Scan before the radiotherapy

Patient with personalized support

Experimental

Consultation with the onco radiotherapeutic and submission of the recommendations to follow before the simulation CT Scan before the radiotherapy and a phone call by a radiotherapy technician

干预措施: Phone call (Other)

结局指标

主要结局

Assess the value of a telephone call in terms of compliance recommendations for preparation (empty rectum and full bladder) necessary to perform the CT scanner simulation in the management of patients with prostate cancer.

时间窗: From the day of the consultation with the radiotherapist to the day of the CT scanner, up to three month after the inclusion

The proportion of patients for whom it is necessary to renew the CT scanner simulation.

次要结局

  • Assess the impact of a telephone call upstream of the simulation scanner on patient preparation according to recommendations.(From the day of the consultation with the radiotherapist to the day of the CT scanner, up to three month after the inclusion)
  • Assess the impact of a telephone call upstream of the simulation scanner on reading the recommendation sheet given to the patient during the announcement medical consultation.(From the day of the consultation with the radiotherapist to the day of the CT scanner, up to three month after the inclusion)

研究者

发起方
Groupe Hospitalier de Bretagne Sud
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rosalie Guegan

Principal Investigator

Groupe Hospitalier de Bretagne Sud

研究点 (2)

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