An Interactive Empowerment Tool for Breast Cancer Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Breast Cancer, Empowerment

Intervention / Treatment
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* Behavioral: Interactive empowerment tool


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interactive empowerment (IEm) group<br>Intervention: Patients fill in the questionnaire online and their profile (obtained from their answers) is immediately sent to the physician | Behavioral: Interactive empowerment tool<br> <br> |
| Sham Comparator: Control<br>Intervention: Patients fill in the questionnaire online, but their profile (obtained from their answers) is not sent to the physician | Behavioral: Interactive empowerment tool<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvements in the Patient Empowerment Score | 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. | Up to 30 min after the visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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empowerment, communication, shared decision making