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

Breast Cancer Clinical Trial

— ALPA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03144037
• Other study ID #: E17086
• Status: Completed
• Start date: April 26, 2017
• Est. completion date: March 19, 2021

Study information

• Verified date: March 2021
• Source: Texas Tech University Health Sciences Center, El Paso
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: March 19, 2021
• Est. primary completion date: March 19, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	Texas Tech University HSC El Paso	El Paso	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center, El Paso

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence rate per the 8-item Morisky Medication Adherence Scale (MMAS - 8).	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.	Every 6 months for up to 24 months