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Clinical Trials/NCT03144037
NCT03144037
Completed
Not Applicable

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

Texas Tech University Health Sciences Center, El Paso1 site in 1 country152 target enrollmentApril 26, 2017
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Texas Tech University Health Sciences Center, El Paso
Enrollment
152
Locations
1
Primary Endpoint
Adherence rate per the 8-item Morisky Medication Adherence Scale (MMAS - 8).
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 26, 2017
End Date
March 19, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Texas Tech University Health Sciences Center, El Paso
Responsible Party
Principal Investigator
Principal Investigator

Alexander Philipovskiy

Assistant Professor

Texas Tech University Health Sciences Center, El Paso

Eligibility Criteria

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

Outcomes

Primary Outcomes

Adherence rate per the 8-item Morisky Medication Adherence Scale (MMAS - 8).

Time Frame: 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.

Study Sites (1)

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