Clinical trial NCT02312700: An Interactive Empowerment Tool for Breast Cancer Patients
Official title: Development of an Interactive Empowerment Tool in Support of Patient Empowerment.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Empowerment
Keywords: empowerment
communication
shared decision making
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2014-12-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Improvements in the Patient Empowerment Score
timeFrame: Up to 30 min after the visit
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: European Institute of Oncology
name: Elisabetta Munzono, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.