Analysis of Initial Adherence and Its Impact on Long-term Adherence to Hormonal Therapy for Breast Cancer

Study Overview
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Brief Summary
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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
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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

Official Title
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Analysis of Initial Adherence and Its Impact on Long-term Adherence to Hormonal Therapy for Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: low adherence intervention group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: high adherence control group<br>-Patients on continuous MEMS monitoring with usual care. | |
| No Intervention: low adherence control group<br>-Patients on continuous MEMS monitoring with usual care. | |
| Experimental: low adherence intervention group<br>Patient with the WALKON mobile application. Patient with monthly feedback call Patients on continuous MEMS monitoring. | Behavioral: low adherence intervention group<br>* Monthly, the study coordinator will give calls to encourage physical activities and medication adherence using MEMS and WALKON activity data.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical activity (daily steps) | Comparison of daily steps using WALKON application | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence using MEMS device | Comparison of adjuvant hormonal therapy adherence using MEMS device | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication Event Monitoring System, adherence