Analysis of Initial Adherence and Its Impact on Long-term Adherence to Hormonal Therapy for Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Gachon University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- physical activity (daily steps)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
high adherence control group
-Patients on continuous MEMS monitoring with usual care.
low adherence control group
-Patients on continuous MEMS monitoring with usual care.
low adherence intervention group
- Patient with the WALKON mobile application.
- Patient with monthly feedback call
- Patients on continuous MEMS monitoring.
Intervention: low adherence intervention group (Behavioral)
Outcomes
Primary Outcomes
physical activity (daily steps)
Time Frame: 12 months
Comparison of daily steps using WALKON application
Secondary Outcomes
- Medication adherence using MEMS device(18 months)
Investigators
Yul Ha Min
Assistant professor
Gachon University