Breast CancerNCT02269033
Redes II National Patient Navigator Intervention Study
A study testing Patient Navigated Latinas and Non Navigated Latinas in people with Breast Cancer, run by The University of Texas Health Science Center at San Antonio.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Patient Navigated Latinas and Non Navigated Latinas
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Patient Navigated Latinas, Non Navigated Latinas
- Keywords
- Breast cancer, Patient Navigation, Health Disparities, Latinas, Breast Imaging Reporting and Data System, BI-RADS, underserved
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Navigated LatinasBehavioural
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.
Non Navigated LatinasBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Non Navigated Latinas |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 30 days
Secondary outcomes (3)
# Barriers
Relationship of # of reported barriers by navigated women and relationship of it to T0-T1 and T1-T2
Measured: 365 days
Patient Satisfaction
Patient satisfaction with navigation provided as measured by Patient Satisfaction scale
Measured: 365 days
Mental Health Status
Patient mental health status pre- and post-navigation
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startSep 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Brooklyn Hospital Center, University of Miami Sylvester Comprehensive Cancer Center, The University of Texas Health Science Center, Houston, University of California, San Francisco, University of California, San Diego
- Responsible party
- Sponsor
- Investigators
- Amelie G Ramirez, DrPH, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269033
- Sponsor's protocol ID
- HSC20080535H
- Other IDs
- U01CA114657
- Status last verified
- Oct 2014
- First submitted
- 15 Oct 2014
- Last updated
- 21 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Redes en Acción: National Patient Navigator Intervention Study
- ClinicalTrials.gov ID
- NCT02269033
- Acronym / sponsor ID
- HSC20080535H
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Patient Navigation, Health Disparities, Latinas, Breast Imaging Reporting and Data System, BI-RADS, underserved
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- The Brooklyn Hospital Center, University of Miami Sylvester Comprehensive Cancer Center, The University of Texas Health Science Center, Houston, University of California, San Francisco, University of California, San Diego
- Study start
- Sep 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 20 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Navigated Latinas | Experimental | Behavioral: Patient Navigated LatinasPatient 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. |
| Non Navigated Latinas | Active comparator | Behavioral: Non Navigated LatinasA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Navigated LatinasPatient 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. | Behavioural | Patient Navigated Latinas |
| Non Navigated LatinasA 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. | Behavioural | Non Navigated Latinas |
Primary outcome
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).
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)
3 secondary outcomes
# Barriers
Time frame: 365 days
Patient Satisfaction
Time frame: 365 days
Mental Health Status
Time frame: 365 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amelie G Ramirez, DrPH principal investigator
The University of Texas Health Science Center at San Antonio
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigated Latinas and Non Navigated Latinas in people with Breast Cancer, run by The University of Texas Health Science Center at San Antonio.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T0-T1; Days from Index Screening to Diagnosis (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2014.