An Interactive Empowerment Tool for Breast Cancer Patients
Primary Purpose
Breast Cancer, Empowerment
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Interactive empowerment tool
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring empowerment, communication, shared decision making
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Interactive empowerment (IEm) group
Control
Arm Description
Intervention: Patients fill in the questionnaire online and their profile (obtained from their answers) is immediately sent to the physician
Intervention: Patients fill in the questionnaire online, but their profile (obtained from their answers) is not sent to the physician
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02312700
First Posted
November 28, 2014
Last Updated
December 5, 2014
Sponsor
University of Milan
1. Study Identification
Unique Protocol Identification Number
NCT02312700
Brief Title
An Interactive Empowerment Tool for Breast Cancer Patients
Official Title
Development of an Interactive Empowerment Tool in Support of Patient Empowerment.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Milan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Empowerment
Keywords
empowerment, communication, shared decision making
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interactive empowerment (IEm) group
Arm Type
Experimental
Arm Description
Intervention: Patients fill in the questionnaire online and their profile (obtained from their answers) is immediately sent to the physician
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Intervention: Patients fill in the questionnaire online, but their profile (obtained from their answers) is not sent to the physician
Intervention Type
Behavioral
Intervention Name(s)
Interactive empowerment tool
Primary Outcome Measure Information:
Title
Improvements in the Patient Empowerment Score
Description
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.
Time Frame
Up to 30 min after the visit
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandra Gorini, PhD
Email
alessandra.gorini@unimi.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabetta Munzono, MD
Organizational Affiliation
European Institute of Oncology
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
24567757
Citation
Kondylakis H, Kazantzaki E, Koumakis L, Genitsaridi I, Marias K, Gorini A, Mazzocco K, Pravettoni G, Burke D, McVie G, Tsiknakis M. Development of interactive empowerment services in support of personalised medicine. Ecancermedicalscience. 2014 Feb 11;8:400. doi: 10.3332/ecancer.2014.400. eCollection 2014.
Results Reference
background
Links:
URL
http://www.p-medicine.eu
Description
Web page of the European project in which the present trial is included
Learn more about this trial
An Interactive Empowerment Tool for Breast Cancer Patients
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