Adherence of Hispanic / Latina Breast Cancer - Patients to Adjuvant Aromatase Inhibitors

Completed

• Conditions: Breast Cancer

• Registration Number: NCT03144037
• Lead Sponsor: Texas Tech University Health Sciences Center, El Paso

Brief Summary

This is an observational trial designed to assess prospectively the adherence rate to AIs among women with invasive breast cancer (stages I-III) currently receiving AI adjuvant therapy after standard local and systemic therapy. We will study adherence by administrating the 8-item Morisky Medication Adherence Scale (MMAS - 8).

Detailed Description

* Women with breast cancer seen at the Texas Tech Physicians Breast Care Center will be recruited during their routine follow-up visit with their medical oncologist.

* Post - menopausal women with histologically confirmed hormonal positive (ER and/or PR) invasive breast cancer stages I - III with no evidence of metastatic disease (M0).

* Patients must be on one of AI (steroidal or non-steroidal).

* Patient must have completed local treatment (surgery /radiation) and recovered from all side effects of chemotherapy and surgery.

* Patient must be able to complete a demographic and the MMAS - 8 questionnaires in English or Spanish.

Study Timeline

• Study Start: 2017-04-26
• Study First Submitted: 2017-05-04
• Study First Submitted QC: 2017-05-04
• Study First Posted: 2017-05-08
• Status Verified: 2021-03
• Primary Completion: 2021-03-19
• Study Completion: 2021-03-19
• Last Update Submitted: 2021-03-24
• Last Update Posted: 2021-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 152

Inclusion Criteria

• Post - menopausal women with histologically confirmed hormonal positive (ER and/or PR) invasive breast cancer stages I - III with no evidence of metastatic disease (M0).
• Patient must have completed local treatment (surgery /radiation) and recovered from all side effects of chemotherapy and surgery.
• Patient must be on one of AI (steroidal or non-steroidal).
• Patient must be able to complete a demographic and the MMAS - 8 questionnaires in English or Spanish

Exclusion Criteria

• < 18 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adherence rate per the 8-item Morisky Medication Adherence Scale (MMAS - 8).	Every 6 months for up to 24 months	Primary endpoint of this study is to determine the adherence rate (high, medium and low) through the MMAS-8 among early stage breast cancer patients being treated at Texas Tech University Health Sciences Center El Paso (TTUHSC EP) where the majority of the patients are of Hispanic origin.

Trial Locations

Locations (1)

Texas Tech University HSC El Paso; 🇺🇸 El Paso, Texas, United States