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An Interactive Empowerment Tool for Breast Cancer Patients

NCT ID: NCT02312700

Last Updated: 2014-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-12-31

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.

Conditions

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Breast Cancer Empowerment

Keywords

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empowerment communication shared decision making

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Interactive empowerment (IEm) group

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

Group Type EXPERIMENTAL

Interactive empowerment tool

Intervention Type BEHAVIORAL

Control

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

Group Type SHAM_COMPARATOR

Interactive empowerment tool

Intervention Type BEHAVIORAL

Interventions

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Interactive empowerment tool

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Milan

OTHER

Sponsor Role lead

Responsible Party

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Alessandra Gorini

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elisabetta Munzono, MD

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncology

Central Contacts

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Alessandra Gorini, PhD

Role: CONTACT

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 24567757 (View on PubMed)

Related Links

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http://www.p-medicine.eu

Web page of the European project in which the present trial is included

Other Identifiers

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270089

Identifier Type: -

Identifier Source: org_study_id