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

Gachon University

Status: Unknown

Conditions: Breast Cancer

Treatments: Behavioral: low adherence intervention group

Study type: Interventional

Funder types: Other

Identifiers

NCT03186599

2016-0351

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 estimated patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 3 patient groups

high adherence control group

No Intervention group

Description:

-Patients on continuous MEMS monitoring with usual care.

low adherence control group

No Intervention group

Description:

-Patients on continuous MEMS monitoring with usual care.

low adherence intervention group

Experimental group

Description:

* Patient with the WALKON mobile application. * Patient with monthly feedback call * Patients on continuous MEMS monitoring.

Treatment:

Behavioral: low adherence intervention group