An Interactive Empowerment Tool for Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02312700
• Other study ID #: 270089
• Status: Not yet recruiting
• Phase: N/A
• First received: November 28, 2014
• Last updated: December 5, 2014
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: December 2014
• Source: University of Milan
• Contact: Alessandra Gorini, PhD
• Email: alessandra.gorini[@]unimi.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 74 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Empowerment

Intervention

Behavioral:
• Interactive empowerment tool

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

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