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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03144037

Acronym

ALPA

Enrollment

152

Registered

2017-05-08

Start date

2017-04-26

Completion date

2021-03-19

Last updated

2021-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results