Redes II National Patient Navigator Intervention Study

Summary

The purpose of this study is to assess the efficacy of a "patient navigator" program that uses a trained community lay health worker to assist Hispanic patients in utilizing cancer care services. This study is a two part study. The first part of the study consists of a retrospective data collection procedure called "baseline clinical chart audit" of 50 Hispanic women over 18 years of age who have had a mammography abnormality classified as BI-RADS 3, 4 or 5. These data will be drawn from the study clinic's existing records and will serve as baseline data for subjects recruited during the course of the study. The second part of the study, the intervention group, involves the recruitment of 50 low-income, Hispanic women who receive abnormal breast cancer screening results (also classified as BI-RADS 3, 4 or 5) from screening services at local community health clinics. Participants will have significantly higher compliance rates and significantly shorter time lags and between an abnormal screening result, and confirmatory screening tests and commencement of treatment, compared to our baseline. The investigators expect at least a 12% increase in after-screening compliance rate and a 25% reduction in time lags in the treatment group, in relation to the pre-intervention baseline assessment.

Conditions

• Breast Cancer

Interventions

BEHAVIORAL

Patient Navigated Latinas

Patient navigators provided culturally sensitive support and guidance to Latina women who presented radiologic abnormalities categorized as BI-RADS 3, 4 and 5. Patient Navigators also collected clinical information from the patients' medical charts.

BEHAVIORAL

Non Navigated Latinas

A convenience sampling approach was used to recruit non navigated Latinas. Eligibility criteria targeted self-identified Latinas at community-based health clinics, aged \> 18 years with an abnormal breast screening mammogram resulting in BI-RADS 3, 4 or 5. Controls were chosen by determining eligibility consecutively backwards from the study start date.

Sponsors & Collaborators

• The Brooklyn Hospital Center

  collaborator OTHER

• University of Miami Sylvester Comprehensive Cancer Center

  collaborator OTHER

• The University of Texas Health Science Center, Houston

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• The University of Texas Health Science Center at San Antonio

  lead OTHER

Principal Investigators

• Amelie G Ramirez, DrPH · The University of Texas Health Science Center at San Antonio

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-09-30

Primary Completion

2010-09-30

Completion

2010-09-30