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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03186599

Enrollment

200

Registered

2017-06-14

Start date

2017-06-08

Completion date

2018-10-31

Last updated

2017-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Medication Event Monitoring System, adherence

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

Interventions

BEHAVIORALlow adherence intervention group

Monthly, the study coordinator will give calls to encourage physical activities and medication adherence using MEMS and WALKON activity data.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
physical activity (daily steps)	12 months	Comparison of daily steps using WALKON application

Secondary

Measure	Time frame	Description
Medication adherence using MEMS device	18 months	Comparison of adjuvant hormonal therapy adherence using MEMS device

Countries

South Korea

Contacts

Primary ContactYul ha Min, PhD

yulha@gachon.ac.kr032-820-4227

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026