Analysis of Initial Adherence and Its Impact on Long-term Adherence to Hormonal Therapy for Breast Cancer
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Jun 2017
Shorter than P25 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 8, 2017
CompletedFirst Submitted
Initial submission to the registry
June 9, 2017
CompletedFirst Posted
Study publicly available on registry
June 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2018
CompletedJune 14, 2017
June 1, 2017
1.4 years
June 9, 2017
June 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
physical activity (daily steps)
Comparison of daily steps using WALKON application
12 months
Secondary Outcomes (1)
Medication adherence using MEMS device
18 months
Study Arms (3)
high adherence control group
NO INTERVENTION-Patients on continuous MEMS monitoring with usual care.
low adherence control group
NO INTERVENTION-Patients on continuous MEMS monitoring with usual care.
low adherence intervention group
EXPERIMENTAL* Patient with the WALKON mobile application. * Patient with monthly feedback call * Patients on continuous MEMS monitoring.
Interventions
Monthly, the study coordinator will give calls to encourage physical activities and medication adherence using MEMS and WALKON activity data.
Eligibility Criteria
You may qualify if:
- Stage 0-III breast cancer
- Treated with Adjuvant hormonal therapy
You may not qualify if:
- Stage IV breast cancer
- Breast cancer recurrence or metastasis
- Severe medical illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gachon Universitylead
- Asan Medical Centercollaborator
Study Sites (1)
Asan Medical center
Seoul, 05505, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yul ha Min, PhD
Gachon University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
June 9, 2017
First Posted
June 14, 2017
Study Start
June 8, 2017
Primary Completion
October 31, 2018
Study Completion
October 31, 2018
Last Updated
June 14, 2017
Record last verified: 2017-06