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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03186599
Other study ID # 2016-0351
Secondary ID
Status Recruiting
Phase N/A
First received June 9, 2017
Last updated June 13, 2017
Start date June 8, 2017
Est. completion date October 31, 2018

Study information

Verified date June 2017
Source Gachon University
Contact Yul ha Min, PhD
Phone 032-820-4227
Email yulha@gachon.ac.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date October 31, 2018
Est. primary completion date October 31, 2018
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 70 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Korea, Republic of Asan Medical center Seoul

Sponsors (2)

Lead Sponsor Collaborator
Gachon University Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary physical activity (daily steps) Comparison of daily steps using WALKON application 12 months
Secondary Medication adherence using MEMS device Comparison of adjuvant hormonal therapy adherence using MEMS device 18 months
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