Back to resultsAnalysis of Initial Adherence and Its Impact on Long-term Adherence to Hormonal Therapy for Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
low adherence intervention group
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring Medication Event Monitoring System, adherence
Eligibility Criteria
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
Sites / Locations
- Asan Medical centerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
No Intervention
Experimental
Arm Label
high adherence control group
low adherence control group
low adherence intervention group
Arm Description
-Patients on continuous MEMS monitoring with usual care.
-Patients on continuous MEMS monitoring with usual care.
Patient with the WALKON mobile application. Patient with monthly feedback call Patients on continuous MEMS monitoring.
Outcomes
Primary Outcome Measures
physical activity (daily steps)
Comparison of daily steps using WALKON application
Secondary Outcome Measures
Medication adherence using MEMS device
Comparison of adjuvant hormonal therapy adherence using MEMS device
Full Information
NCT ID
NCT03186599
First Posted
June 9, 2017
Last Updated
June 13, 2017
Sponsor
Gachon University
Collaborators
Asan Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03186599
Brief Title
Analysis of Initial Adherence and Its Impact on Long-term Adherence to Hormonal Therapy for Breast Cancer
Official Title
Analysis of Initial Adherence and Its Impact on Long-term Adherence to Hormonal Therapy for Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 8, 2017 (Actual)
Primary Completion Date
October 31, 2018 (Anticipated)
Study Completion Date
October 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gachon University
Collaborators
Asan Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Medication Event Monitoring System, adherence
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
high adherence control group
Arm Type
No Intervention
Arm Description
-Patients on continuous MEMS monitoring with usual care.
Arm Title
low adherence control group
Arm Type
No Intervention
Arm Description
-Patients on continuous MEMS monitoring with usual care.
Arm Title
low adherence intervention group
Arm Type
Experimental
Arm Description
Patient with the WALKON mobile application.
Patient with monthly feedback call
Patients on continuous MEMS monitoring.
Intervention Type
Behavioral
Intervention Name(s)
low adherence intervention group
Intervention Description
Monthly, the study coordinator will give calls to encourage physical activities and medication adherence using MEMS and WALKON activity data.
Primary Outcome Measure Information:
Title
physical activity (daily steps)
Description
Comparison of daily steps using WALKON application
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Medication adherence using MEMS device
Description
Comparison of adjuvant hormonal therapy adherence using MEMS device
Time Frame
18 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yul ha Min, PhD
Phone
032-820-4227
Email
yulha@gachon.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yul ha Min, PhD
Organizational Affiliation
Gachon University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Sun Lee, RN
Phone
010-8964-9614
Email
minsunlee1989@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Analysis of Initial Adherence and Its Impact on Long-term Adherence to Hormonal Therapy for Breast Cancer
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