Redes II National Patient Navigator Intervention Study

October 20, 2014 updated by: The University of Texas Health Science Center at San Antonio

Redes en Acción: National Patient Navigator Intervention Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Breast cancer is the leading cause of cancer-related deaths in Latinas, chiefly because of later diagnosis. The time from screening to diagnosis is critical to optimizing cancer care, yet the efficacy of navigation in reducing it is insufficiently documented. Here the investigators evaluate a culturally sensitive patient navigation program to reduce the time to diagnosis and increase the proportions of women diagnosed within 30 days and 60 days. METHODS. The investigators analyzed 425 Latinas who had Breast Imaging Reporting and Data System (BI-RADS) radiologic abnormalities categorized as BI-RADS-3, BI-RADS-4, or BI-RADS-5 from July 2008 to January 2011. There were 217 women in the navigated group and 208 women in the control group. Women were navigated by locally trained navigators or were not navigated (data for this group were abstracted from charts). The Kaplan-Meier method, Cox proportional hazards regression, and logistic regression were used to determine differences between groups. RESULTS. The time to diagnosis was shorter in the navigated group (mean, 32.5 days vs 44.6 days in the control group; hazard ratio, 1.32; P ¼ .007). Stratified analysis revealed that navigation significantly shortened the time to diagnosis among women who had BI-RADS-3 radiologic abnormalities (mean, 21.3 days vs 63.0 days; hazard ratio, 2.42; P < .001) but not among those who had BI-RADS-4 or BI-RADS-5 radiologic abnormalities (mean, 37.6 days vs 36.9 days; hazard ratio, 0.98; P ¼ .989). Timely diagnosis occurred more frequently among navigated Latinas (within 30 days: 67.3% vs 57.7%; P ¼ .045; within 60 days: 86.2% vs 78.4%; P ¼ .023). This was driven by the BI-RADS-3 strata (within 30 days: 83.6% vs 50%; P < .001; within 60 days: 94.5% vs 67.2%; P < .001). A lack of missed appointments was associated with timely diagnosis. CONCLUSIONS. Patient-centered navigation to assist Latina women with abnormal screening mammograms appeared to reduced the time to diagnosis and increase rates of timely diagnosis overall. However, in stratified analyses, only navigated Latinas with an initial BI-RADS-3 screen benefited, probably because of a reduction in missed diagnostic appointments in this group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
480

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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: 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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
T0-T1; Days from Index Screening to Diagnosis
Time Frame: 30 days
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
Time Frame: 30 days
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
# Barriers
Time Frame: 365 days
Relationship of # of reported barriers by navigated women and relationship of it to T0-T1 and T1-T2
365 days
Patient Satisfaction
Time Frame: 365 days
Patient satisfaction with navigation provided as measured by Patient Satisfaction scale
365 days
Mental Health Status
Time Frame: 365 days
Patient mental health status pre- and post-navigation
365 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center at San Antonio

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The University of Texas Health Science Center, Houston
University of California, San Diego
University of California, San Francisco
The Brooklyn Hospital Center
University of Miami Sylvester Comprehensive Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amelie G Ramirez, DRPH, The University of Texas Health Science Center at San Antonio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSC20080535H
  • U01CA114657 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings