Development of an Interactive Empowerment Tool in Support of Patient Empowerment.
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
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
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
Alessandra Gorini
Researcher
University of Milan
