An Interactive Empowerment Tool for Breast Cancer Patients

NCT02312700 | Unknown

• 1 other identifier: 270089
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer; Empowerment

Keywords

empowerment; communication; shared decision making

Outcome Measures

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.

  Up to 30 min after the visit

Study Arms (2)

Interactive empowerment (IEm) group

EXPERIMENTAL

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

Behavioral: Interactive empowerment tool

Control

SHAM COMPARATOR

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

Interactive empowerment tool BEHAVIORAL

Control; Interactive empowerment (IEm) group

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Milan: lead

Related 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.

  PMID: 24567757 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms; Empowerment; Communication

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Social Behavior; Behavior

Study Officials

• Elisabetta Munzono, MD

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandra Gorini, PhD

CONTACT

alessandra.gorini@unimi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: November 28, 2014
• First Posted: December 9, 2014
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 9, 2014

Record last verified: 2014-12