Analysis of Initial Adherence and Its Impact on Long-term Adherence to Hormonal Therapy for Breast Cancer

Not Applicable

• Conditions: Breast Cancer
• Interventions: Behavioral: low adherence intervention group

• Registration Number: NCT03186599
• Lead Sponsor: Gachon University

Brief Summary

A trial will be conducted on 200 breast cancer patients with adjuvant hormonal therapy. The study included 6 months baseline measurement, and 12 months intervention. Patients will be assigned to high adherence or low adherence group. Then, through randomization, low adherence patients will be assigned to the intervention or control group. Study Coordinator delivers the intervention using the WALKON mobile application. Control participants receive usual care with continuous monitoring using Medication Event Monitoring System (MEMS) device.

Detailed Description

* Baseline measurement (n=200): screening and enrollment

* 3-month visit: collecting MEMS data

* 6-month visit: collecting MEMS data and assigned to the high adherence (n=70) or low adherence group (n=75). The low adherence intervention group (n=75) will be educated about the WALKON mobile application.

* 12-month visit: Control group: collecting MEMS data intervention group: monthly calls + collecting MEMS data

* 18-month visit: collecting MEMS data and interview

Study Timeline

• Status Verified: 2017-06
• Study Start: 2017-06-08
• Study First Submitted: 2017-06-09
• Study First Submitted QC: 2017-06-13
• Last Update Submitted: 2017-06-13
• Study First Posted: 2017-06-14
• Last Update Posted: 2017-06-14
• Primary Completion: 2018-10-31
• Study Completion: 2018-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Stage 0-III breast cancer
• Treated with Adjuvant hormonal therapy

Exclusion Criteria

• Stage IV breast cancer
• Breast cancer recurrence or metastasis
• Severe medical illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low adherence intervention group	low adherence intervention group	* Patient with the WALKON mobile application. * Patient with monthly feedback call * Patients on continuous MEMS monitoring.

Primary Outcome Measures

Name	Time	Method
physical activity (daily steps)	12 months	Comparison of daily steps using WALKON application

Secondary Outcome Measures

Name	Time	Method
Medication adherence using MEMS device	18 months	Comparison of adjuvant hormonal therapy adherence using MEMS device

Trial Locations

Locations (1)

Asan Medical center; 🇰🇷 Seoul, Korea, Republic of