Community Services Navigation to Advance Health Equity in Breast Cancer Screening

Обзор

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.

Подробное описание

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

Вмешательства

• Поведенческое 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.
• Другое Usual Care
  Standard referral to community resources.

Первичные конечные точки

• Change in Social Needs [Срок оценки: up to 18 months after baseline assessment]
• Episode Completion (EC). [Срок оценки: up to 18 months after baseline assessment]

Вторичные конечные точки (10)

• Area deprivation index (ADI) [Срок оценки: up to 18 months after baseline assessment]
• Rural Urban Commuting Area (RUCA) [Срок оценки: up to 18 months after baseline assessment]
• Social Service Utilization [Срок оценки: up to 18 months after baseline assessment]
• Breast cancer risk (Tyrer-Cuzick) [Срок оценки: up to 18 months after baseline assessment]
• General Health Status [Срок оценки: up to 18 months after baseline assessment]
• Self-Report Generated Charlson Comorbidity Index [Срок оценки: up to 18 months after baseline assessment]
• Preventive services visits [Срок оценки: from baseline assessment, up to 18 months]
• PROMIS Global Health [Срок оценки: up to 18 months after baseline assessment]
• PROMIS Depression [Срок оценки: up to 18 months after baseline assessment]
• Health Care Access [Срок оценки: up to 18 months after baseline assessment]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• University of Utah Health Hospitals/Huntsman Cancer Institute Population Sciences — Salt Lake City

Публикации

• 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. PMID 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. PMID 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. PMID 28972651

Идентификаторы

NCT: NCT06305312 · HCI166685 · 1R01CA282409-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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