Community Services Navigation to Advance Health Equity in Breast Cancer Screening

NCT06305312 | Recruiting

• 2 other identifiers: HCI1666851R01CA282409-01
• Study Type: interventional
• Target: 1,450
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (10)

• Area deprivation index (ADI)

  up to 18 months after baseline assessment

• Rural Urban Commuting Area (RUCA)

  up to 18 months after baseline assessment

• Social Service Utilization

  up to 18 months after baseline assessment

• Breast cancer risk (Tyrer-Cuzick)

  up to 18 months after baseline assessment

• General Health Status

  up to 18 months after baseline assessment

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Standard referrals to community resources will be used for participants randomized to usual care.

Other: 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.

Behavioral: Community Service Navigation

Interventions

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.

Intervention

Usual Care OTHER

Standard referral to community resources.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Utah Health Hospitals/Huntsman Cancer Institute Population Sciences

Salt Lake City, Utah, 84112, United States

RECRUITING

Related Publications (99)

• 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.

  BACKGROUND

• 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.

  PMID: 28751476 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 23454732 BACKGROUND

• 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.

  PMID: 28972651 BACKGROUND

• 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.

  PMID: 19363399 BACKGROUND

• 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.

  PMID: 28430705 BACKGROUND

• 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.

  PMID: 26223824 BACKGROUND

• 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.

  PMID: 29618934 BACKGROUND

• 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.

  PMID: 29968031 BACKGROUND

• 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.

  PMID: 23169513 BACKGROUND

• 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.

  PMID: 11148575 BACKGROUND

• Bradley CJ, Neumark D, Shickle LM, Farrell N. Differences in breast cancer diagnosis and treatment: experiences of insured and uninsured women in a safety-net setting. Inquiry. 2008 Fall;45(3):323-39. doi: 10.5034/inquiryjrnl_45.03.323.

  PMID: 19069013 BACKGROUND

• Drake BF, Abadin SS, Lyons S, Chang SH, Steward LT, Kraenzle S, Goodman MS. Mammograms on-the-go-predictors of repeat visits to mobile mammography vans in St Louis, Missouri, USA: a case-control study. BMJ Open. 2015 Mar 20;5(3):e006960. doi: 10.1136/bmjopen-2014-006960.

  PMID: 25795693 BACKGROUND

• Mizuguchi S, Barkley L, Rai S, Pan J, Roland L, Crawford S, Riley EC. Mobile Mammography, Race, and Insurance: Use Trends Over a Decade at a Comprehensive Urban Cancer Center. J Oncol Pract. 2015 Jan;11(1):e75-80. doi: 10.1200/JOP.2014.001477. Epub 2014 Nov 4.

  PMID: 25371543 BACKGROUND

• Schunemann HJ, Lerda D, Quinn C, Follmann M, Alonso-Coello P, Rossi PG, Lebeau A, Nystrom L, Broeders M, Ioannidou-Mouzaka L, Duffy SW, Borisch B, Fitzpatrick P, Hofvind S, Castells X, Giordano L, Canelo-Aybar C, Warman S, Mansel R, Sardanelli F, Parmelli E, Grawingholt A, Saz-Parkinson Z, European Commission Initiative on Breast Cancer Contributor G. Breast Cancer Screening and Diagnosis: A Synopsis of the European Breast Guidelines. Ann Intern Med. 2019

  BACKGROUND

• Bleicher RJ, Ruth K, Sigurdson ER, Beck JR, Ross E, Wong YN, Patel SA, Boraas M, Chang EI, Topham NS, Egleston BL. Time to Surgery and Breast Cancer Survival in the United States. JAMA Oncol. 2016 Mar;2(3):330-9. doi: 10.1001/jamaoncol.2015.4508.

  PMID: 26659430 BACKGROUND

• Ashing-Giwa KT, Gonzalez P, Lim JW, Chung C, Paz B, Somlo G, Wakabayashi MT. Diagnostic and therapeutic delays among a multiethnic sample of breast and cervical cancer survivors. Cancer. 2010 Jul 1;116(13):3195-204. doi: 10.1002/cncr.25060.

  PMID: 20564623 BACKGROUND

• Gorin SS, Heck JE, Cheng B, Smith SJ. Delays in breast cancer diagnosis and treatment by racial/ethnic group. Arch Intern Med. 2006 Nov 13;166(20):2244-52. doi: 10.1001/archinte.166.20.2244.

  PMID: 17101943 BACKGROUND

• George P, Chandwani S, Gabel M, Ambrosone CB, Rhoads G, Bandera EV, Demissie K. Diagnosis and surgical delays in African American and white women with early-stage breast cancer. J Womens Health (Larchmt). 2015 Mar;24(3):209-17. doi: 10.1089/jwh.2014.4773. Epub 2015 Feb 4.

  PMID: 25650628 BACKGROUND

• Elmore JG, Nakano CY, Linden HM, Reisch LM, Ayanian JZ, Larson EB. Racial inequities in the timing of breast cancer detection, diagnosis, and initiation of treatment. Med Care. 2005 Feb;43(2):141-8. doi: 10.1097/00005650-200502000-00007.

  PMID: 15655427 BACKGROUND

• Ryu EB, Chang JM, Seo M, Kim SA, Lim JH, Moon WK. Tumour volume doubling time of molecular breast cancer subtypes assessed by serial breast ultrasound. Eur Radiol. 2014 Sep;24(9):2227-35. doi: 10.1007/s00330-014-3256-0. Epub 2014 Jun 4.

  PMID: 24895040 BACKGROUND

• Neal RD, Tharmanathan P, France B, Din NU, Cotton S, Fallon-Ferguson J, Hamilton W, Hendry A, Hendry M, Lewis R, Macleod U, Mitchell ED, Pickett M, Rai T, Shaw K, Stuart N, Torring ML, Wilkinson C, Williams B, Williams N, Emery J. Is increased time to diagnosis and treatment in symptomatic cancer associated with poorer outcomes? Systematic review. Br J Cancer. 2015 Mar 31;112 Suppl 1(Suppl 1):S92-107. doi: 10.1038/bjc.2015.48.

  PMID: 25734382 BACKGROUND

• Polverini AC, Nelson RA, Marcinkowski E, Jones VC, Lai L, Mortimer JE, Taylor L, Vito C, Yim J, Kruper L. Time to Treatment: Measuring Quality Breast Cancer Care. Ann Surg Oncol. 2016 Oct;23(10):3392-402. doi: 10.1245/s10434-016-5486-7. Epub 2016 Aug 8.

  PMID: 27503492 BACKGROUND

• Kaufman CS, Shockney L, Rabinowitz B, Coleman C, Beard C, Landercasper J, Askew JB Jr, Wiggins D; Quality Initiative Committee. National Quality Measures for Breast Centers (NQMBC): a robust quality tool: breast center quality measures. Ann Surg Oncol. 2010 Feb;17(2):377-85. doi: 10.1245/s10434-009-0729-5. Epub 2009 Oct 16.

  PMID: 19834768 BACKGROUND

• Comber H, Cronin DP, Deady S, Lorcain PO, Riordan P. Delays in treatment in the cancer services: impact on cancer stage and survival. Ir Med J. 2005 Sep;98(8):238-9.

  PMID: 16255115 BACKGROUND

• Brazda A, Estroff J, Euhus D, Leitch AM, Huth J, Andrews V, Moldrem A, Rao R. Delays in time to treatment and survival impact in breast cancer. Ann Surg Oncol. 2010 Oct;17 Suppl 3:291-6. doi: 10.1245/s10434-010-1250-6. Epub 2010 Sep 19.

  PMID: 20853049 BACKGROUND

• Ramachandran A, Snyder FR, Katz ML, Darnell JS, Dudley DJ, Patierno SR, Sanders MR, Valverde PA, Simon MA, Warren-Mears V, Battaglia TA; Patient Navigation Research Program Investigators. Barriers to health care contribute to delays in follow-up among women with abnormal cancer screening: Data from the Patient Navigation Research Program. Cancer. 2015 Nov 15;121(22):4016-24. doi: 10.1002/cncr.29607. Epub 2015 Aug 19.

  PMID: 26385420 BACKGROUND

• Henderson LM, O'Meara ES, Haas JS, Lee CI, Kerlikowske K, Sprague BL, Alford-Teaster J, Onega T. The Role of Social Determinants of Health in Self-Reported Access to Health Care Among Women Undergoing Screening Mammography. J Womens Health (Larchmt). 2020 Nov;29(11):1437-1446. doi: 10.1089/jwh.2019.8267. Epub 2020 May 5.

  PMID: 32366199 BACKGROUND

• Fallahian F, Nelson H, Pories S. The Role of Social Determinants of Health on Cancer Screening. 2022; https://www.facs.org/for-medical-professionals/news-publications/news-and-articles/bulletin/june-2022-volume-107-number-6/the-role-of-social-determinants-of-health-on-cancer-screening/.

  BACKGROUND

• Alegria M, Araneta MR, Rivers B. The National Advisory Council on Minority Health and Health Disparities Reflection. Am J Public Health. 2019 Jan;109(S1):S14-S15. doi: 10.2105/AJPH.2019.304961. No abstract available.

  PMID: 30699030 BACKGROUND

• Social Determinants of Health. Health topics 2022; https://www.who.int/health-topics/social-determinants-of-health#tab=tab_1. Accessed September 30, 2022.

  BACKGROUND

• Centers for Disease Control and Prevention. Addressing Social Determinants of Health: Accelerating the Prevention and Control of HIV/AIDS, Viral Hepatitis, STD and TB. Atlanta, Georgia2009.

  BACKGROUND

• Centers for Disease Control and Prevention. Centers for Disease Control and Prevention. Social Determinants of Health: Know What Affects Health. 2021; https://www.cdc.gov/socialdeterminants/.

  BACKGROUND

• Maroko AR, Doan TM, Arno PS, Hubel M, Yi S, Viola D. Integrating Social Determinants of Health With Treatment and Prevention: A New Tool to Assess Local Area Deprivation. Prev Chronic Dis. 2016 Sep 15;13:E128. doi: 10.5888/pcd13.160221.

  PMID: 27634778 BACKGROUND

• Phillips RL, Liaw W, Crampton P, Exeter DJ, Bazemore A, Vickery KD, Petterson S, Carrozza M. How Other Countries Use Deprivation Indices-And Why The United States Desperately Needs One. Health Aff (Millwood). 2016 Nov 1;35(11):1991-1998. doi: 10.1377/hlthaff.2016.0709.

  PMID: 27834238 BACKGROUND

• DeMilto L, Nakashian M. Using social determinants of health data to improve health care and health: A learning report. Robert Wood Johnson Foundation. 2016;1:15

  BACKGROUND

• Committee on Educating Health Professionals to Address the Social Determinants of Health; Board on Global Health; Institute of Medicine; National Academies of Sciences, Engineering, and Medicine. A Framework for Educating Health Professionals to Address the Social Determinants of Health. Washington (DC): National Academies Press (US); 2016 Oct 14. Available from http://www.ncbi.nlm.nih.gov/books/NBK395983/

  PMID: 27854400 BACKGROUND

• Garg A, Boynton-Jarrett R, Dworkin PH. Avoiding the Unintended Consequences of Screening for Social Determinants of Health. JAMA. 2016 Aug 23-30;316(8):813-4. doi: 10.1001/jama.2016.9282. No abstract available.

  PMID: 27367226 BACKGROUND

• Henderson V, Tossas-Milligan K, Martinez E, Williams B, Torres P, Mannan N, Green L, Thompson B, Winn R, Watson KS. Implementation of an integrated framework for a breast cancer screening and navigation program for women from underresourced communities. Cancer. 2020 May 15;126 Suppl 10:2481-2493. doi: 10.1002/cncr.32843.

  PMID: 32348565 BACKGROUND

• 211 Get Help Give Help. 2022; https://211utah.org/. Accessed September 30, 2022.

  BACKGROUND

• Wallace AS, Luther B, Guo JW, Wang CY, Sisler S, Wong B. Implementing a Social Determinants Screening and Referral Infrastructure During Routine Emergency Department Visits, Utah, 2017-2018. Prev Chronic Dis. 2020 Jun 18;17:E45. doi: 10.5888/pcd17.190339.

  PMID: 32553071 BACKGROUND

• Guo JW, Wallace AS, Luther BL, Wong B. Psychometric Evaluation of the Screener for Intensifying Community Referrals for Health. Eval Health Prof. 2022 Sep;45(3):270-276. doi: 10.1177/01632787211029360. Epub 2021 Jul 8.

  PMID: 34235988 BACKGROUND

• Wallace AS, Luther BL, Sisler SM, Wong B, Guo JW. Integrating social determinants of health screening and referral during routine emergency department care: evaluation of reach and implementation challenges. Implement Sci Commun. 2021 Oct 7;2(1):114. doi: 10.1186/s43058-021-00212-y.

  PMID: 34620248 BACKGROUND

• Sharareh N, Wallace AS, Brintz BJ, Wan N, Guo JW, Wong B. Associated factors with patient-reported unmet food needs among emergency department adult patients - A social need perspective. Prev Med Rep. 2022 Sep 7;29:101974. doi: 10.1016/j.pmedr.2022.101974. eCollection 2022 Oct.

  PMID: 36161133 BACKGROUND

• MQSA National Statistics. 2022; https://www.fda.gov/radiation-emitting-products/mqsa-insights/mqsa-national-statistics. Accessed May 20, 2022.

  BACKGROUND

• Aday LA, Andersen R. A framework for the study of access to medical care. Health Serv Res. 1974 Fall;9(3):208-20.

  PMID: 4436074 BACKGROUND

• Andersen R, Bozzette S, Shapiro M, St Clair P, Morton S, Crystal S, Goldman D, Wenger N, Gifford A, Leibowitz A, Asch S, Berry S, Nakazono T, Heslin K, Cunningham W. Access of vulnerable groups to antiretroviral therapy among persons in care for HIV disease in the United States. HCSUS Consortium. HIV Cost and Services Utilization Study. Health Serv Res. 2000 Jun;35(2):389-416.

  PMID: 10857469 BACKGROUND

• Andersen RM. Revisiting the behavioral model and access to medical care: does it matter? J Health Soc Behav. 1995 Mar;36(1):1-10.

  PMID: 7738325 BACKGROUND

• Andersen RM, Davidson PL. Improving access to care in America. Changing the US Health Care System. 2nd ed. San Fransisco: Josey-Bass; 2001.

  BACKGROUND

• Gelberg L, Andersen RM, Leake BD. The Behavioral Model for Vulnerable Populations: application to medical care use and outcomes for homeless people. Health Serv Res. 2000 Feb;34(6):1273-302.

  PMID: 10654830 BACKGROUND

• Phillips KA, Morrison KR, Andersen R, Aday LA. Understanding the context of healthcare utilization: assessing environmental and provider-related variables in the behavioral model of utilization. Health Serv Res. 1998 Aug;33(3 Pt 1):571-96.

  PMID: 9685123 BACKGROUND

• Miller KA, Hillier D, Russ C, Luercio M, Winn AS. Applying Self-Determination Theory to Redesign an Inpatient Care Team. Acad Pediatr. 2019 Apr;19(3):351-353. doi: 10.1016/j.acap.2018.09.010. Epub 2018 Oct 9. No abstract available.

  PMID: 30312681 BACKGROUND

• Partelow S. A review of the social-ecological systems framework: applications, methods, modifications, and challenges. Ecology and Society. 2018;23(4)

  BACKGROUND

• Henderson LM, Hubbard RA, Zhu W, Weiss J, Wernli KJ, Goodrich ME, Kerlikowske K, DeMartini W, Ozanne EM, Onega T. Preoperative Breast Magnetic Resonance Imaging Use by Breast Density and Family History of Breast Cancer. J Womens Health (Larchmt). 2018 Aug;27(8):987-993. doi: 10.1089/jwh.2017.6428. Epub 2018 Jan 15.

  PMID: 29334616 BACKGROUND

• Onega T, Weiss JE, Goodrich ME, Zhu W, DeMartini WB, Kerlikowske K, Ozanne E, Tosteson ANA, Henderson LM, Buist DSM, Wernli KJ, Herschorn SD, Hotaling E, O'Donoghue C, Hubbard R. Relationship between preoperative breast MRI and surgical treatment of non-metastatic breast cancer. J Surg Oncol. 2017 Dec;116(8):1008-1015. doi: 10.1002/jso.24796. Epub 2017 Nov 11.

  PMID: 29127715 BACKGROUND

• Ozanne EM, Weiss JE, Onega T, DeMartini W, Kerlikowske K, Buist DS, Henderson L, Hubbard RA, Goodrich M, Tosteson AN, Virnig BA, O'Donoghue C. Locoregional treatment of breast cancer in women with and without preoperative magnetic resonance imaging. Am J Surg. 2017 Jan;213(1):132-139.e2. doi: 10.1016/j.amjsurg.2016.03.014. Epub 2016 Jun 12.

  PMID: 27421187 BACKGROUND

• Ballard-Barbash R, Taplin SH, Yankaskas BC, Ernster VL, Rosenberg RD, Carney PA, Barlow WE, Geller BM, Kerlikowske K, Edwards BK, Lynch CF, Urban N, Chrvala CA, Key CR, Poplack SP, Worden JK, Kessler LG. Breast Cancer Surveillance Consortium: a national mammography screening and outcomes database. AJR Am J Roentgenol. 1997 Oct;169(4):1001-8. doi: 10.2214/ajr.169.4.9308451. No abstract available.

  PMID: 9308451 BACKGROUND

• Incidence Rate Report for Utah by County, Breast (Late Stage), 2014-2018, White Non-Hispanic, Female, All Ages. https://statecancerprofiles.cancer.gov/incidencerates/index.php?stateFIPS=49&areatype=county&cancer=055&race=07&sex=2&age=001&stage=211&year=0&type=incd&sortVariableName=rate&sortOrder=default&output=0#results. Accessed Oct 11, 2021.

  BACKGROUND

• Onega T, Tosteson TD, Weiss J, Haas JS, Goodrich M, DiFlorio R, Brackett C, Clark C, Harris K, Tosteson ANA. Multi-level Influences on Breast Cancer Screening in Primary Care. J Gen Intern Med. 2018 Oct;33(10):1729-1737. doi: 10.1007/s11606-018-4560-1. Epub 2018 Aug 3.

  PMID: 30076569 BACKGROUND

• Beaber EF, Sprague BL, Tosteson ANA, Haas JS, Onega T, Schapira MM, McCarthy AM, Li CI, Herschorn SD, Lehman CD, Wernli KJ, Barlow WE. Multilevel Predictors of Continued Adherence to Breast Cancer Screening Among Women Ages 50-74 Years in a Screening Population. J Womens Health (Larchmt). 2019 Aug;28(8):1051-1059. doi: 10.1089/jwh.2018.6997. Epub 2018 Nov 27.

  PMID: 30481098 BACKGROUND

• Schapira MM, Barlow WE, Conant EF, Sprague BL, Tosteson ANA, Haas JS, Onega T, Beaber EF, Goodrich M, McCarthy AM, Herschorn SD, Skinner CS, Harrington TO, Geller B. Communication Practices of Mammography Facilities and Timely Follow-up of a Screening Mammogram with a BI-RADS 0 Assessment. Acad Radiol. 2018 Sep;25(9):1118-1127. doi: 10.1016/j.acra.2017.12.028. Epub 2018 Feb 9.

  PMID: 29433892 BACKGROUND

• Buist DSM, Gao H, Anderson ML, Onega T, Brandzel S, Rabelhofer MA, Bradford SC, Aiello Bowles EJ. Breast cancer screening outreach effectiveness: Mammogram-specific reminders vs. comprehensive preventive services birthday letters. Prev Med. 2017 Sep;102:49-58. doi: 10.1016/j.ypmed.2017.06.028. Epub 2017 Jun 24.

  PMID: 28655547 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.

  PMID: 33606032 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.

  PMID: 16509834 BACKGROUND

• Euhus DM. Breast cancer prevention in the 21st century: defining the challenge. Breast J. 2006 Mar-Apr;12(2):97-8. doi: 10.1111/j.1075-122X.2006.00215.x. No abstract available.

  PMID: 16509832 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.

  PMID: 17319855 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.

  PMID: 24422989 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.

  PMID: 26475704 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.

  PMID: 32034829 BACKGROUND

• Cancer Screening and Education Bus. Cancer Screening & Prevention https://healthcare.utah.edu/huntsmancancerinstitute/screening-prevention/mobile-screening.php. Accessed September 30, 2022.

  BACKGROUND

• Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam Med. 2004 Sep;36(8):588-94.

  PMID: 15343421 BACKGROUND

• Chew LD, Griffin JM, Partin MR, Noorbaloochi S, Grill JP, Snyder A, Bradley KA, Nugent SM, Baines AD, Vanryn M. Validation of screening questions for limited health literacy in a large VA outpatient population. J Gen Intern Med. 2008 May;23(5):561-6. doi: 10.1007/s11606-008-0520-5. Epub 2008 Mar 12.

  PMID: 18335281 BACKGROUND

• Sarkar U, Schillinger D, Lopez A, Sudore R. Validation of self-reported health literacy questions among diverse English and Spanish-speaking populations. J Gen Intern Med. 2011 Mar;26(3):265-71. doi: 10.1007/s11606-010-1552-1. Epub 2010 Nov 6.

  PMID: 21057882 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.

  PMID: 25292294 BACKGROUND

• Charlson M, Szatrowski TP, Peterson J, Gold J. Validation of a combined comorbidity index. J Clin Epidemiol. 1994 Nov;47(11):1245-51. doi: 10.1016/0895-4356(94)90129-5.

  PMID: 7722560 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.

  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.

  PMID: 27683670 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.

  PMID: 28141929 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.

  PMID: 32506999 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.

  PMID: 28822325 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/.

  BACKGROUND

• Cozzi A, Schiaffino S, Giorgi Rossi P, Sardanelli F. Breast cancer screening: in the era of personalized medicine, age is just a number. Quant Imaging Med Surg. 2020 Dec;10(12):2401-2407. doi: 10.21037/qims-2020-26. No abstract available.

  PMID: 33269240 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.

  PMID: 26658934 BACKGROUND

• Baum JK, Hanna LG, Acharyya S, Mahoney MC, Conant EF, Bassett LW, Pisano ED. Use of BI-RADS 3-probably benign category in the American College of Radiology Imaging Network Digital Mammographic Imaging Screening Trial. Radiology. 2011 Jul;260(1):61-7. doi: 10.1148/radiol.11101285. Epub 2011 Apr 18.

  PMID: 21502382 BACKGROUND

• Breast Imaging Reporting & Data System (BI-RADS (R)). 2013; https://www.acr.org/Clinical-Resources/Reporting-and-Data-Systems/Bi-Rads. Accessed July 25, 2022.

  BACKGROUND

• Bevers TB, Anderson BO, Bonaccio E, Buys S, Daly MB, Dempsey PJ, Farrar WB, Fleming I, Garber JE, Harris RE, Heerdt AS, Helvie M, Huff JG, Khakpour N, Khan SA, Krontiras H, Lyman G, Rafferty E, Shaw S, Smith ML, Tsangaris TN, Williams C, Yankeelov T; National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: breast cancer screening and diagnosis. J Natl Compr Canc Netw. 2009 Nov;7(10):1060-96. doi: 10.6004/jnccn.2009.0070. No abstract available.

  PMID: 19930975 BACKGROUND

• Guest G, MacQueen KM, Namey EE. Applied Thematic Analysis. SAGE Publications, Inc.; 2012.

  BACKGROUND

• Glaser BG, Strauss AL. Discovery of Grounded Theory: Strategies for Qualitative Research. Routledge; 2017.

  BACKGROUND

• Krippendorff K. Quantitative guidelines for communicable disease control programs. Biometrics. 1978 Mar;34(1):142. No abstract available.

  PMID: 630036 BACKGROUND

• Morse JM. The Significance of Saturation. Qualitative Health Research. 1995;5(2):147-149

  BACKGROUND

• Guest G, Bunce A, Johnson L. How Many Interviews Are Enough?:An Experiment with Data Saturation and Variability. Field Methods. 2006;18(1):59-82

  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.

  BACKGROUND

• 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.

  PMID: 40859259 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Elissa Ozanne, PhD

  Huntsman Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elissa Ozanne, PhD

CONTACT

801-213-4130; Elissa.Ozanne@hsc.utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 12, 2024
• Study Start: April 30, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)