Redes II National Patient Navigator Intervention Study

NCT02269033 | Completed DMC

• 2 other identifiers: HSC20080535HU01CA114657
• Study Type: interventional
• Target: 480
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Breast cancer; Patient Navigation; Health Disparities; Latinas; Breast Imaging Reporting and Data System, BI-RADS; underserved

Outcome Measures

Primary Outcomes (2)

• T0-T1; Days from Index Screening to Diagnosis

  Number of days from date of index screening abnormality to definitive diagnosis and the proportion achieving timely diagnosis (within 30 days or 60 days of screening).

  30 days

• T1-T2; Days from Diagnosis to Treatment Initiation

  Number of days from date of definitive diagnosis to initiation of treatment and the proportion achieving timely treatment (within 30 or 60 days of diagnosis)

  30 days

Secondary Outcomes (3)

• # Barriers

  365 days

• Patient Satisfaction

  365 days

• Mental Health Status

  365 days

Study Arms (2)

Patient Navigated Latinas

EXPERIMENTAL

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: Patient Navigated Latinas

Non Navigated Latinas

ACTIVE COMPARATOR

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.

Behavioral: Non Navigated Latinas

Interventions

Patient Navigated Latinas BEHAVIORAL

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.

Patient Navigated Latinas

Non Navigated Latinas BEHAVIORAL

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.

Non Navigated Latinas

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English and Spanish speaking female Hispanics over 18 years of age who attend this clinic and who receive mammography screening results specified as BI-RADS 3, 4 or 5, will be offered participation in the study.
• Although not actively recruited, pregnant women will not be excluded from the study sample

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• The Brooklyn Hospital Center: collaborator
• University of Miami Sylvester Comprehensive Cancer Center: collaborator
• The University of Texas Health Science Center, Houston: collaborator
• University of California, San Francisco: collaborator
• University of California, San Diego: collaborator

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Amelie G Ramirez, DrPH

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: October 20, 2014
• Study Start: September 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 21, 2014

Record last verified: 2014-10