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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA282409-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Active Comparator | Standard referrals to community resources will be used for participants randomized to usual care. |
|
| Intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 18 months after baseline assessment |
| 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. | up to 18 months after baseline assessment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 18 months after baseline assessment |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elissa Ozanne, PhD | Contact | 801-213-4130 | Elissa.Ozanne@hsc.utah.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elissa Ozanne, PhD | Huntsman Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah Health Hospitals/Huntsman Cancer Institute Population Sciences | Recruiting | Salt Lake City | Utah | 84112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Cancer Stat Facts: Female Breast Cancer. 2022; https://seer.cancer.gov/statfacts/html/breast.html. Accessed Jul 11, 2022. | ||
| Background | Underserved group. Toolkit for Patient-Focused Therapy Development https://toolkit.ncats.nih.gov/glossary/underserved-group/. Accessed September 30, 2022. | ||
| Background | American Cancer Society. Cancer Facts & Figures for Hispanics/Latinos 2018-2020. Atlanta2018. | ||
| Background | 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. | ||
| 28751476 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Usual Care | Other | Standard referral to community resources. |
|
| 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. | up to 18 months after baseline assessment |
| 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. | up to 18 months after baseline assessment |
| 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. | up to 18 months after baseline assessment |
| 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. | up to 18 months after baseline assessment |
| 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. | up to 18 months after baseline assessment |
| 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. | from baseline assessment, up to 18 months |
| 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. | up to 18 months after baseline assessment |
| 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. | up to 18 months after baseline assessment |
| 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. | up to 18 months after baseline assessment |
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| 33606032 | Background | Lee CI, Zhu W, Onega T, Henderson LM, Kerlikowske K, Sprague BL, Rauscher GH, O'Meara ES, Tosteson ANA, Haas JS, diFlorio-Alexander R, Kaplan C, Miglioretti DL. Comparative Access to and Use of Digital Breast Tomosynthesis Screening by Women's Race/Ethnicity and Socioeconomic Status. JAMA Netw Open. 2021 Feb 1;4(2):e2037546. doi: 10.1001/jamanetworkopen.2020.37546. |
| 16509834 | Background | Ozanne EM, Klemp JR, Esserman LJ. Breast cancer risk assessment and prevention: a framework for shared decision-making consultations. Breast J. 2006 Mar-Apr;12(2):103-13. doi: 10.1111/j.1075-122X.2006.00217.x. |
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| 17319855 | Background | Ozanne EM, Annis C, Adduci K, Showstack J, Esserman L. Pilot trial of a computerized decision aid for breast cancer prevention. Breast J. 2007 Mar-Apr;13(2):147-54. doi: 10.1111/j.1524-4741.2007.00395.x. |
| 24422989 | Background | Ozanne EM, Howe R, Omer Z, Esserman LJ. Development of a personalized decision aid for breast cancer risk reduction and management. BMC Med Inform Decis Mak. 2014 Jan 14;14:4. doi: 10.1186/1472-6947-14-4. |
| 26475704 | Background | Ozanne EM, Schneider KH, Soeteman D, Stout N, Schrag D, Fordis M, Punglia RS. onlineDeCISion.org: a web-based decision aid for DCIS treatment. Breast Cancer Res Treat. 2015 Nov;154(1):181-90. doi: 10.1007/s10549-015-3605-y. |
| 32034829 | Background | Ozanne EM, Soeteman DI, Frank ES, Clarke J, Hassett MJ, Stout NK, Punglia RS. Commentary: Creating a patient-centered decision aid for ductal carcinoma in situ. Breast J. 2020 Jul;26(7):1498-1499. doi: 10.1111/tbj.13779. Epub 2020 Feb 8. No abstract available. |
| Background | Cancer Screening and Education Bus. Cancer Screening & Prevention https://healthcare.utah.edu/huntsmancancerinstitute/screening-prevention/mobile-screening.php. Accessed September 30, 2022. |
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| 25292294 | Background | Warwick J, Birke H, Stone J, Warren RM, Pinney E, Brentnall AR, Duffy SW, Howell A, Cuzick J. Mammographic breast density refines Tyrer-Cuzick estimates of breast cancer risk in high-risk women: findings from the placebo arm of the International Breast Cancer Intervention Study I. Breast Cancer Res. 2014 Oct 8;16(5):451. doi: 10.1186/s13058-014-0451-5. |
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| Background | Hailu D, Asnake. Guidelines for Using Rural-Urban Classification Systems for Community Health Assessment. In: Health WSDo, ed: Washington State Department of Health; 2016:1-26. |
| 27683670 | Background | Knighton AJ, Savitz L, Belnap T, Stephenson B, VanDerslice J. Introduction of an Area Deprivation Index Measuring Patient Socioeconomic Status in an Integrated Health System: Implications for Population Health. EGEMS (Wash DC). 2016 Aug 11;4(3):1238. doi: 10.13063/2327-9214.1238. eCollection 2016. |
| 28141929 | Background | Onega T, Haas JS, Bitton A, Brackett C, Weiss J, Goodrich M, Harris K, Pyle S, Tosteson AN. Alignment of breast cancer screening guidelines, accountability metrics, and practice patterns. Am J Manag Care. 2017 Jan;23(1):35-40. |
| 32506999 | Background | Schiffelbein JE, Carluzzo KL, Hasson RM, Alford-Teaster JA, Imset I, Onega T. Barriers, Facilitators, and Suggested Interventions for Lung Cancer Screening Among a Rural Screening-Eligible Population. J Prim Care Community Health. 2020 Jan-Dec;11:2150132720930544. doi: 10.1177/2150132720930544. |
| 28822325 | Background | Raffin E, Onega T, Bynum J, Austin A, Carmichael D, Bronner K, Goodney P, Hyams ES. Are there regional tendencies toward controversial screening practices? A study of prostate and breast cancer screening in a Medicare population. Cancer Epidemiol. 2017 Oct;50(Pt A):68-75. doi: 10.1016/j.canep.2017.07.015. Epub 2017 Aug 17. |
| Background | Haas J, Schapira M, Sprague B, Tosteson A, Klabunde C, Chen J, Bitton A, Beaber E, Onega T, Kim J, MacLean C. Changes in Primary Care Practice Following New USPSTF Breast and Cervical Cancer Screening Guidelines. AcademyHealth 2015 Annual Research Meeting; June 15, 2015. |
| Background | National Cancer Institute Division of Cancer Control & Population Sciences. Population-based Research to Optimize the Screening Process (PROSPR). 2021; https://healthcaredelivery.cancer.gov/prospr/prospr1/. |
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| 26658934 | Background | Tosteson AN, Beaber EF, Tiro J, Kim J, McCarthy AM, Quinn VP, Doria-Rose VP, Wheeler CM, Barlow WE, Bronson M, Garcia M, Corley DA, Haas JS, Halm EA, Kamineni A, Rutter CM, Tosteson TD, Trentham-Dietz A, Weaver DL; PROSPR consortium. Variation in Screening Abnormality Rates and Follow-Up of Breast, Cervical and Colorectal Cancer Screening within the PROSPR Consortium. J Gen Intern Med. 2016 Apr;31(4):372-9. doi: 10.1007/s11606-015-3552-7. |
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| Background | Center for HOPE. 2022; https://healthcare.utah.edu/huntsmancancerinstitute/about-us/center-for-hope.php. Accessed September 30, 2022. |
| Background | Center for HOPE. Huntsman Cancer Institute Research 2022; https://uofuhealth.utah.edu/huntsman/labs/center-for-hope. Accessed September 30, 2022. |
| 40859259 | Derived | Beck K, Mitchell M, Wallace AS, Freer PE, Wong B, Kepka D, Watt MH, McNall S, Kolomaya A, Ariotti A, Mulford M, Onega T, Ozanne EM. Community navigation intervention for social needs in patients with abnormal mammography: a randomized controlled trial study protocol. BMC Public Health. 2025 Aug 26;25(1):2926. doi: 10.1186/s12889-025-24372-x. |
| D017437 |
| Skin and Connective Tissue Diseases |