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Breast CancerB-SINCERENCT06305312

Community Services Navigation to Advance Health Equity in Breast Cancer Screening

A study testing Community Service Navigation in people with Breast Cancer, run by University of Utah at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Community Service Navigation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,450 participants
Where
1 siteUnited States
Study dates
30 Apr 2024to Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • English and Spanish speakers
  • Received an abnormal result of a screening mammogram
  • Self-reports at least one social need on the B-SINCERE Screener

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Elissa Ozanne, PhD contact

801-213-4130

Elissa.Ozanne@hsc.utah.edu

United States1 site, 1 recruiting
  • University of Utah Health Hospitals/Huntsman Cancer Institute Population Sciences

    Salt Lake City, Utah, 84112

    Elissa Ozanne, PhD, 801-213-4130, Elissa.Ozanne@hsc.utah.edu

    Tracy Onega, PhD

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

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

Conditions
Breast Cancer
Being tested
Community Service Navigation, Usual Care
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Community Service NavigationBehavioural

    Patients randomized to the intervention will be directly referred to the United Way of Salt Lake's 211 community referral service for additional outreach.

  • Usual CareOther

    Standard referral to community resources.

Study groups in NCT06305312
Study groupRoleWhat they receive
Usual CareActive comparatorStandard referrals to community resources will be used for participants randomized to usual care.
Receives: Other: Usual Care
InterventionExperimentalCommunity 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.
Receives: Behavioral: Community Service Navigation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Social Needs

    Change in participants' level of social needs as measured by the B-SINCERE (Breast-Screener for Intensifying Community Referrals for Health) screener. To Test whether the use of a community services navigation intervention in conjunction with social service referrals decreases social needs compared to the referrals alone (usual care). B-SINCERE, reported on a 0-10 point scale, with 0=No Social Needs present, and 1-10=Social Needs present, anything greater than 0 indicates social needs and eligibility for the study.

    Measured: up to 18 months after baseline assessment

  2. Episode Completion (EC).

    EC is the name of a dichotomous scale, reported on a 2-point scale that is calculated from patient electronic health record (EHR), with 0=No Breast Cancer Screening completed, 1=Breast Cancer Screening completed.

    Impact of the community services navigation intervention on breast cancer screening episode completion and preventive care utilization among women with self-reported social needs. Preventive Care Utilization is a descriptive measure that is not reporting a score on a scale.

    Measured: up to 18 months after baseline assessment

Secondary outcomes (10)
  1. Area deprivation index (ADI)

    DI is a tool for assessing an area's socioeconomic conditions. Scores range from 1-100, with lower scores indicating minimal socioeconomic disadvantage and higher scores indicating more socioeconomic disadvantage. This outcome measure will report ADI at 6 and 18 months of rural vs urban participants (based on ZIP codes) after baseline.

    Measured: up to 18 months after baseline assessment

  2. Rural Urban Commuting Area (RUCA)

    RUCA assesses urbanization, population density, and commuting. Scores range from 1 to 10, with lower scores indicating more urban areas and higher scores representing more rural areas. This outcome measure will report RUCA at 6 and 18 months of rural vs urban participants (based on ZIP codes) after baseline.

    Measured: up to 18 months after baseline assessment

  3. Social Service Utilization

    Social Service Utilization will assess how many study participants utilize 211 social services. This outcome measure will report the proportion of participants utilizing the following 211 medical care services: Finding healthy food, Adult education/job training/employment, Clothing/supplies, Housing, Transportation, Paying for health care, Paying bills, Child care, Other, 211 didn't help me get any services. This outcome measure will report social service utilization at 1, 6, and 18 months after the baseline assessment.

    Measured: up to 18 months after baseline assessment

  4. Breast cancer risk (Tyrer-Cuzick)

    The Tyrer-Cuzick breast cancer risk score estimates the likelihood of developing breast cancer. Scores range from 0 to 100 with lower scores indicating low breast cancer risk and high scores indicating high breast cancer risk. This outcome measure will report the mean breast cancer risk score at 6 and 18 months after the baseline assessment.

    Measured: up to 18 months after baseline assessment

  5. General Health Status

    General Health Status is a scale assessing general health. Scores range from 0 to 5, with lower scores indicating better health and higher scores indicating worse health. This outcome measure will report General Health Status at 1, 6, and 18 months after the baseline assessment.

    Measured: up to 18 months after baseline assessment

  6. Self-Report Generated Charlson Comorbidity Index

    Charlson Comorbidity Index is a score predicting mortality risk based on comorbidities. Scores range from 1 to 37, with lower scores indicating better mortality risk and higher scores representing worse mortality risk.

    This outcome measure will report the mean Charlson Comorbidity Index at 6 and 18 months after the baseline assessment.

    Measured: up to 18 months after baseline assessment

  7. Preventive services visits

    Preventive services visits will measure how many participants complete their preventive visits. This outcome measure will report the proportion of participants who completed preventive visits such as the next annual mammogram, cervical cancer screening, or colorectal cancer screening. This outcome measure will report the proportion completing preventive services visits at 1, 6, and 18 months after the baseline assessment.

    Measured: from baseline assessment, up to 18 months

  8. PROMIS Global Health

    PROMIS Global Health is a questionnaire assessing participants' health. Scores range from 0 to 32, with lower scores indicating worse health and higher scores indicating better health. This outcome measure will report PROMIS Global Health at 1, 6, and 18 months after the baseline assessment.

    Measured: up to 18 months after baseline assessment

  9. PROMIS Depression

    PROMIS Depression is a questionnaire assessing participants' mental health. Scores range from 0 to 32, with lower scores indicating better mental health and higher scores indicating worse mental health. This outcome measure will report PROMIS Depression at 1, 6, and 18 months after the baseline assessment.

    Measured: up to 18 months after baseline assessment

  10. Health Care Access

    Healthcare access is a 4-item questionnaire assessing patients' access to healthcare. Scores range from 0-12, with lower scores indicating worse access to healthcare and higher scores indicating better access to healthcare. This outcome measure will report Health Care Access at 6 and 18 months after the baseline assessment.

    Measured: up to 18 months after baseline assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2024
  2. Study start30 Apr 2024
  3. Primary completionSep 2028 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06305312
Sponsor's protocol ID
HCI166685
Other IDs
1R01CA282409-01
Acronym
B-SINCERE
Status last verified
Jul 2025
First submitted
29 Feb 2024
Last updated
1 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cancer Stat Facts: Female Breast Cancer. 2022; https://seer.cancer.gov/statfacts/html/breast.html. Accessed Jul 11, 2022.

  • Underserved group. Toolkit for Patient-Focused Therapy Development https://toolkit.ncats.nih.gov/glossary/underserved-group/. Accessed September 30, 2022.

  • American Cancer Society. Cancer Facts & Figures for Hispanics/Latinos 2018-2020. Atlanta2018.

  • Centers for Disease Control and Prevention National Center for Health Statistics. Death Rates for Selected Cancers by Race and Ethnicity, US, 2010-2014. 2016; https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2017/death-rates-for-selected-cancers-by-race-and-ethnicity-us-2010-2014.pdf. Accessed Oct 11, 2021.

  • Zahnd WE, James AS, Jenkins WD, Izadi SR, Fogleman AJ, Steward DE, Colditz GA, Brard L. Rural-Urban Differences in Cancer Incidence and Trends in the United States. Cancer Epidemiol Biomarkers Prev. 2018 Nov;27(11):1265-1274. doi: 10.1158/1055-9965.EPI-17-0430. Epub 2017 Jul 27.

    PubMed 28751476
  • Death Rates for Selected Cancers by Race and Ethnicity, US, 2010-2014. 2016; https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2017/death-rates-for-selected-cancers-by-race-and-ethnicity-us-2010-2014.pdf. Accessed Oct 11, 2021.

  • Henry KA, Sherman R, Farber S, Cockburn M, Goldberg DW, Stroup AM. The joint effects of census tract poverty and geographic access on late-stage breast cancer diagnosis in 10 US States. Health Place. 2013 May;21:110-21. doi: 10.1016/j.healthplace.2013.01.007. Epub 2013 Mar 1.

    PubMed 23454732
  • DeSantis CE, Ma J, Goding Sauer A, Newman LA, Jemal A. Breast cancer statistics, 2017, racial disparity in mortality by state. CA Cancer J Clin. 2017 Nov;67(6):439-448. doi: 10.3322/caac.21412. Epub 2017 Oct 3.

    PubMed 28972651
  • Doescher MP, Jackson JE. Trends in cervical and breast cancer screening practices among women in rural and urban areas of the United States. J Public Health Manag Pract. 2009 May-Jun;15(3):200-9. doi: 10.1097/PHH.0b013e3181a117da.

    PubMed 19363399
  • Roche LM, Niu X, Stroup AM, Henry KA. Disparities in Female Breast Cancer Stage at Diagnosis in New Jersey: A Spatial-Temporal Analysis. J Public Health Manag Pract. 2017 Sep/Oct;23(5):477-486. doi: 10.1097/PHH.0000000000000524.

    PubMed 28430705
  • Williams F, Jeanetta S, O'Brien DJ, Fresen JL. Rural-urban difference in female breast cancer diagnosis in Missouri. Rural Remote Health. 2015 Jul-Sep;15(3):3063. Epub 2015 Jul 29.

    PubMed 26223824
  • Vlahiotis A, Griffin B, Stavros AT, Margolis J. Analysis of utilization patterns and associated costs of the breast imaging and diagnostic procedures after screening mammography. Clinicoecon Outcomes Res. 2018 Mar 26;10:157-167. doi: 10.2147/CEOR.S150260. eCollection 2018.

    PubMed 29618934
  • Bleicher RJ. Timing and Delays in Breast Cancer Evaluation and Treatment. Ann Surg Oncol. 2018 Oct;25(10):2829-2838. doi: 10.1245/s10434-018-6615-2. Epub 2018 Jul 2.

    PubMed 29968031
  • Bleicher RJ, Ruth K, Sigurdson ER, Ross E, Wong YN, Patel SA, Boraas M, Topham NS, Egleston BL. Preoperative delays in the US Medicare population with breast cancer. J Clin Oncol. 2012 Dec 20;30(36):4485-92. doi: 10.1200/JCO.2012.41.7972. Epub 2012 Nov 19.

    PubMed 23169513
  • Bradley CJ, Given CW, Roberts C. Disparities in cancer diagnosis and survival. Cancer. 2001 Jan 1;91(1):178-88. doi: 10.1002/1097-0142(20010101)91:13.0.co;2-s.

    PubMed 11148575

Questions about this trial

What is this clinical trial studying?

A study testing Community Service Navigation in people with Breast Cancer, run by University of Utah at 1 site in United States.

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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elissa Ozanne, PhD (801-213-4130, Elissa.Ozanne@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Social Needs (time frame: up to 18 months after baseline assessment). 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?

On the ClinicalTrials.gov record for NCT06305312, which also lists 99 linked publications.

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 1 Aug 2025.

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