Adherence of Hispanic / Latina Breast Cancer - Patients t... | NCT03144037

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

NCT03144037

Sponsor

Texas Tech University Health Sciences Center, El Paso

Status

Completed

Last Update Posted

Mar 29, 2021Actual

Enrollment

152Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 26, 2017Actual

Primary Completion Date

Mar 19, 2021Actual

Completion Date

Mar 19, 2021Actual

First Submitted Date

May 4, 2017

First Submission Date that Met QC Criteria

May 4, 2017

First Posted Date

May 8, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2021

Last Update Posted Date

Mar 29, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alexander Philipovskiy, Assistant Professor, Texas Tech University Health Sciences Center, El PasoPrincipal Investigator

Lead Sponsor

Texas Tech University Health Sciences Center, El PasoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

152Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Majority of patients are females who are currently on AIs.

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Hispanic population is targeted, yet study is open for all those who qualify.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexander Philipovskiy, MD, PhD	Texas Tech University Health Sciences Center, El Paso	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Texas Tech University HSC El Paso		El Paso	Texas	79905	United States

Type	Date	Date Unknown
Release	May 18, 2021
Reset	Jun 11, 2021
Release	Oct 11, 2023
Reset	Apr 5, 2024

Submission Tracking

Estimated Results First Submitted Date

May 18, 2021

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
May 18, 2021			Jun 11, 2021
Oct 11, 2023

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided