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NCT Number: NCT06305312

Community Services Navigation to Advance Health Equity in Breast Cancer Screening

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah Health Hospitals/Huntsman Cancer Institute Population Sciences

Salt Lake City, Utah, 84112, United States

Location status: Recruiting

Location contact

Elissa Ozanne, PhD

CONTACT

[email protected]

801-213-4130

Tracy Onega, PhD

SUB_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Community Service Navigation

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.

Usual Care

Other

Standard referral to community resources.

Primary outcomes

  1. Change in Social Needs

    Time frame: up to 18 months after baseline assessment

    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.

  2. Episode Completion (EC).

    Time frame: up to 18 months after baseline assessment

    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.

Secondary outcomes

  1. Area deprivation index (ADI)

    Time frame: up to 18 months after baseline assessment

    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.

  2. Rural Urban Commuting Area (RUCA)

    Time frame: up to 18 months after baseline assessment

    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.

  3. Social Service Utilization

    Time frame: up to 18 months after baseline assessment

    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.

  4. Breast cancer risk (Tyrer-Cuzick)

    Time frame: up to 18 months after baseline assessment

    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.

  5. General Health Status

    Time frame: up to 18 months after baseline assessment

    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.

  6. Self-Report Generated Charlson Comorbidity Index

    Time frame: up to 18 months after baseline assessment

    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.

  7. Preventive services visits

    Time frame: from baseline assessment, up to 18 months

    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.

  8. PROMIS Global Health

    Time frame: up to 18 months after baseline assessment

    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.

  9. PROMIS Depression

    Time frame: up to 18 months after baseline assessment

    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.

  10. Health Care Access

    Time frame: up to 18 months after baseline assessment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elissa Ozanne, PhD

CONTACT

[email protected]

801-213-4130

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Acronym: B-SINCERE

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Mar 12, 2024
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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