跳至主要内容
临床试验/NCT02312700
NCT02312700Unknown不适用

Development of an Interactive Empowerment Tool in Support of Patient Empowerment.

University of Milan0 个研究点目标入组 100 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
主要终点
Improvements in the Patient Empowerment Score

研究概览

简要总结

The study is aimed to verify the effect of an online interactive tool on patient empowerment. The tool is based on a validated psychological questionnaire administrated to breast cancer patients before their first encounter with physician.

详细描述

The study is intended to develop an IEm (Interactive Empowerment) tool aimed at enhancing physician-patient experience by providing physicians a personalized patient's profile, accompanied by a list of recommendations to suggest him how to interact with that specific patient on the basis of his/her personal profile. Developed in the framework of the FP7 project "P-Medicine", the IEm tool uses the ALGA-BC questionnaire, a recent validated instrument specifically developed to perform a brief evaluation of the breast cancer patients' psychological status, to provide the physician a patient's profile based on 8 factors. As soon as the questionnaire has been completed, the patient's answers are automatically elaborated and sent to the physician's computer. Provided to the physicians at the very beginning of the visit, such information is supposed to be crucial for them to find a tailored way to communicate with the patient. Moreover, in order to help physicians to correctly interpret the patient's score, any time the scores are out of a certain range (normal values) they will receive a recommendation that helps them to find the best way to interact with the patient. Supposing that the patient empowerment can be reached through the improved patient's participation in the clinical process, we argue that a more effective and personalized interaction between patient and physician may have a key role in promoting it.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 74 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •The patient is aged 18 to 74 years at randomisation.
  • •The patient has been diagnosed as having a primary breast cancer requiring a radical surgery
  • •The patient is able to understand the Informed Consent Form, and understand study procedures.
  • •The patient has signed the Informed Consent Form.

排除标准

  • •The patient has a recurrent breast cancer diagnosis
  • •The patient has an overt psychiatric illness that would interfere with the measurement of the psychological variables included in the questionnaire
  • •Inability to freely consent to take part in the study
  • •Inability to understand the study materials.
  • •Current participation in another clinical trial relating to the breast cancer treatment
  • •Any condition that, in the researcher's opinion, compromises the subject's ability to meet protocol requirements or to complete the study.

研究组 & 干预措施

Interactive empowerment (IEm) group

Experimental

Intervention: Patients fill in the questionnaire online and their profile (obtained from their answers) is immediately sent to the physician

干预措施: Interactive empowerment tool (Behavioral)

Control

Sham Comparator

Intervention: Patients fill in the questionnaire online, but their profile (obtained from their answers) is not sent to the physician

干预措施: Interactive empowerment tool (Behavioral)

结局指标

主要结局

Improvements in the Patient Empowerment Score

时间窗: Up to 30 min after the visit

Patient empowerment score will be measured in the experimental versus the control group by mean of patients' comprehension level relatively to the information doctors provided to them.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alessandra Gorini

Researcher

University of Milan

相似试验