CClinicalTrials.gg
Status unknownNCT02312700Updated Dec 9, 2014

An Interactive Empowerment Tool for Breast Cancer Patients

An interventional study of Interactive empowerment tool in Breast Cancer and Empowerment, sponsored by University of Milan. Status unknown. Open to female participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2014-12-09.

Sponsored by University of Milan · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Dec 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 74 Years
Sex
Female
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Study 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.

Read the 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.

02

Conditions studied

  • Breast Cancer
  • Empowerment

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Keywords

  • empowerment
  • communication
  • shared decision making
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 100 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University of Milan is the lead sponsor of 177 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 74 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Interactive empowerment (IEm) group

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

    Behavioral: Interactive empowerment tool

  • Sham comparator
    Control

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

    Behavioral: Interactive empowerment tool

Interventions

  • BehavioralInteractive empowerment tool
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 30 min after the visit

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Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 24567757 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02312700
Lead sponsor
University of Milan
Responsible party
Alessandra Gorini (Researcher, University of Milan) — Principal investigator
First posted
Dec 9, 2014
Start date
Jan 2015
Primary completion
Dec 2015 (estimated)
Completion
Dec 2015 (estimated)
Last update
Dec 9, 2014

Study contacts

Alessandra Gorini, PhD
Contact
alessandra.gorini@unimi.it
Elisabetta Munzono, MD
principal investigator · European Institute of Oncology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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