Breast Cancer Clinical Trial
Official title:
Analysis of Initial Adherence and Its Impact on Long-term Adherence to Hormonal Therapy for Breast Cancer
Verified date | June 2017 |
Source | Gachon University |
Contact | Yul ha Min, PhD |
Phone | 032-820-4227 |
yulha[@]gachon.ac.kr | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Asan Medical center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Gachon University | Asan Medical Center |
Korea, Republic of,
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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