search
Back to results

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
University of Milan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring empowerment, communication, shared decision making

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. The patient has a recurrent breast cancer diagnosis
  2. The patient has an overt psychiatric illness that would interfere with the measurement of the psychological variables included in the questionnaire
  3. Inability to freely consent to take part in the study
  4. Inability to understand the study materials.
  5. Current participation in another clinical trial relating to the breast cancer treatment
  6. 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

    First Posted
    November 28, 2014
    Last Updated
    December 5, 2014
    Sponsor
    University of Milan
    search

    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

    We'll reach out to this number within 24 hrs