Community Services Navigation to Advance Health Equity in Breast Cancer Screening
NCT ID: NCT06305312
Last Updated: 2025-08-01
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
1450 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-04-30
Study Completion Date
2028-09-30
Brief Summary
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The goal of this study is to evaluate if adding community services navigation to the standard referral process for social needs is an effective and scalable strategy for addressing disparities in follow-up to abnormal breast cancer screening results. The investigators will determine the effectiveness of social needs referrals combined with a community services navigation intervention in the screening mammography setting to improving breast screening outcomes in underserved women.
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Detailed Description
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Disparities in breast cancer outcomes are persistent. In the United States, breast cancer is the most common, and second most deadly, cancer in women, with an estimated 281,550 new invasive breast cancer diagnoses and 43,600 breast cancer deaths in 2021. Underserved women, those who do not have adequate access to medical care, are represented disproportionately in those deaths, having lower incidence rates but higher mortality rates. While U.S. breast cancer mortality rates have decreased approximately 2% per year since 1990, socially and economically disadvantaged women have experienced increasing breast cancer mortality over that time. Rural women are more likely to experience diagnostic delays and are up to 1.5 times more likely to be diagnosed with advanced stages of disease compared with urban women.
Leveraging existing social systems for community navigation to facilitate breast screening follow-up. Our research has demonstrated that linkages between social needs screening in clinical settings and United Way 211's community referral service is possible using existing, low cost software solutions that can be adapted to clinical workflows. Specifically, the SINCERE 10-item social needs screener was combined with community services navigation and tested in a randomized controlled trial. That trial showed efficacy of the efficacy of this low cost, widely available solution to address the needs of vulnerable and underserved patients; namely, 211 active outreach v. passive information to address reported social needs. However, that trial was conducted in an Emergency Department, and has not been tested in other clinical settings. Building off of (collective) decades of work in breast cancer screening, the multiple PIs have formed an interdisciplinary team that has piloted an adaptation of the SINCERE social services screener (dubbed "B-SINCERE") in mammography clinics. This study will test the real-world efficacy (NIH stage 3) of the B-SINCERE community navigation intervention on increasing breast cancer screening episode completion. If efficacious, this intervention will be scalable with statewide community service providers and existing health information technology. Thus, the promise to make a real impact on early detection and improve breast cancer outcomes for underserved women with abnormal mammograms is the overarching driver of this work
Leveraging existing social systems for community navigation to facilitate breast screening follow-up. Our research has demonstrated that linkages between social needs screening in clinical settings and United Way 211's community referral service is possible using existing, low cost software solutions that can be adapted to clinical workflows. Specifically, the SINCERE 10-item social needs screener was combined with community services navigation and tested in a randomized controlled trial. That trial showed efficacy of the efficacy of this low cost, widely available solution to address the needs of vulnerable and underserved patients; namely, 211 active outreach v. passive information to address reported social needs. However, that trial was conducted in an Emergency Department, and has not been tested in other clinical settings. Building off of (collective) decades of work in breast cancer screening, the multiple PIs have formed an interdisciplinary team that has piloted an adaptation of the SINCERE social services screener (dubbed "B-SINCERE") in mammography clinics. This study will test the real-world efficacy (NIH stage 3) of the B-SINCERE community navigation intervention on increasing breast cancer screening episode completion. If efficacious, this intervention will be scalable with statewide community service providers and existing health information technology. Thus, the promise to make a real impact on early detection and improve breast cancer outcomes for underserved women with abnormal mammograms is the overarching driver of this work
Conditions
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Breast Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
HEALTH_SERVICES_RESEARCH
Blinding Strategy
NONE
Study Groups
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Usual Care
Standard referrals to community resources will be used for participants randomized to usual care.
Group Type
ACTIVE_COMPARATOR
Usual Care
Intervention Type
OTHER
Standard referral to community resources.
Intervention
Community Services Navigation with 211 Information Specialists (ISs) will conduct outreach to participants within 48 hours of referral through telephone, text, or email, depending on patient preference. Two weeks after initial contact ISs follow up with patients to provide additional support and document use of the referred services in ServicePoint.
Group Type
EXPERIMENTAL
Community Service Navigation
Intervention Type
BEHAVIORAL
Patients randomized to the intervention will be directly referred to the United Way of Salt Lake's 211 community referral service for additional outreach.
Interventions
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Community Service Navigation
Patients randomized to the intervention will be directly referred to the United Way of Salt Lake's 211 community referral service for additional outreach.
Intervention Type
BEHAVIORAL
Usual Care
Standard referral to community resources.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* English and Spanish speakers
* Received an abnormal result of a screening mammogram
* Self-reports at least one social need on the B-SINCERE Screener
* Received an abnormal result of a screening mammogram
* Self-reports at least one social need on the B-SINCERE Screener
Exclusion Criteria
* Patients who are currently in treatment for breast cancer
* Patients with a normal screening result.
* Patients who do not exhibit at least 1 social need according to their SINCERE screening result.
* Patients who don't speak English or Spanish
* Cognitive limitations that impede informed consent
* Patients living outside of Utah
* Patients with a normal screening result.
* Patients who do not exhibit at least 1 social need according to their SINCERE screening result.
* Patients who don't speak English or Spanish
* Cognitive limitations that impede informed consent
* Patients living outside of Utah
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Institutes of Health (NIH)
NIH
Sponsor Role
collaborator
National Cancer Institute (NCI)
NIH
Sponsor Role
collaborator
University of Utah
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Elissa Ozanne, PhD
Role: PRINCIPAL_INVESTIGATOR
Huntsman Cancer Institute
Locations
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University of Utah Health Hospitals/Huntsman Cancer Institute Population Sciences
Salt Lake City, Utah, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HCI166685
Identifier Type: -
Identifier Source: org_study_id
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