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NCT Number: NCT03144037

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

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).

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Texas Tech University HSC El Paso

El Paso, Texas, 79905, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center, El Paso

Other

Registry information

Official study title

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

Acronym: ALPA

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 8, 2017
Registry last updated
Mar 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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