Survey Conducted Among Early Breast Cancer Patients Treated With Arimidex for Evaluation of Treatment Adherence (ARIADNE)

November 15, 2011 updated by: AstraZeneca

Survey and Follow-up of the Treatment Adherence and Medication Habits of Early Breast Cancer Patients on Adjuvant Hormonal Therapy With the Aromatase Inhibitor Arimidex

The aim of this study is to assess the patient's perception about and willingness to take his or her medication and the influencing factors interfering with taking medication.

Study Overview

Status

Completed

Conditions

Breast Cancer

Study Type

Observational

Enrollment (Actual)

1077

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Hungary
- - Balatonfoldvar, Hungary
    - Research Site
  - Bekescsaba, Hungary
    - Research Site
  - Budapest, Hungary
    - Research Site
  - Debrecen, Hungary
    - Research Site
  - Dombovar, Hungary
    - Research Site
  - Gyongyos, Hungary
    - Research Site
  - Gyor, Hungary
    - Research Site
  - Gyula, Hungary
    - Research Site
  - Kaposvar, Hungary
    - Research Site
  - Kecskemet, Hungary
    - Research Site
  - Miskolc, Hungary
    - Research Site
  - Mosdos, Hungary
    - Research Site
  - Nagyatad, Hungary
    - Research Site
  - Nyiregyhaza, Hungary
    - Research Site
  - Orfu, Hungary
    - Research Site
  - Papa, Hungary
    - Research Site
  - Pecs, Hungary
    - Research Site
  - Szeged, Hungary
    - Research Site
  - Szekesfehervar, Hungary
    - Research Site
  - Szekszard, Hungary
    - Research Site
  - Szentes, Hungary
    - Research Site
  - Szombathely, Hungary
    - Research Site
  - Veszprem, Hungary
    - Research Site
  - Zalaegerszeg, Hungary
    - Research Site
  - Zirc, Hungary
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Early breast cancer patients on adjuvant aromatase inhibitor

Description

Inclusion Criteria:

Early breast cancer
Post menopausal
Adjuvant hormonal Arimidex therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent of patients remaining adherent to therapy with Arimidex Time Frame: Every 3 months	Every 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Questionnaire for factors influencing adherence Time Frame: Every 3 months	Every 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

Principal Investigator: Zsolt Horvath, M.D., Ph.D., Hungarian National Institute of Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

March 4, 2010

First Submitted That Met QC Criteria