Enhancing Mammography Programs for Outreach, Wellness, Education, and Resources (EMPOWER) in Underserved Populations Study

Overview

This study is investigating the feasibility of a digital tool called a chatbot for providing educational information about mammography through a tablet, computer, or phone. This study will recruit participants who recently had a mammogram with the University of Utah. Based on their mammography results, women will be placed into two cohorts using their BI-RADS category. Once mammogram results are available, patients will be randomized 1:1 to either usual care or usual care with chatbot. This study will randomly invite participants from four groups for focus group discussions (FGDs) based on their mammogram results and adherence to screening recommendations

Detailed description

Breast cancer screening inequities are drivers of disparities for rural and Latina women.

Chatbots are increasingly popular in various healthcare contexts and can be easily accessed through smartphones, tablets, laptops, and desktops. Chatbots have many advantages for patient messaging, including providing scripted education and motivational information interactively, chunking information into digestible segments, and allowing for choice in the amount of information received at any one time. Thus, with chatbots this study can tailor the interaction based on individual patient factors. Chatbots are accessible to the vast majority of U.S. adults. While chatbots have been used successfully in some clinical contexts, there is a lack of studies that investigated the use of chatbots as part of a mobile screening program to increase adherence to follow-up recommendations about either screening or diagnostic care.

Study staff will approach women at the time of or soon after a patient's routine breast cancer screening and invite the patient to participate in the study. Participants will complete baseline surveys at time of enrollment. This survey includes demographics and preferred contact method (e.g., text, email) that will be used to initiate the chatbot communication which can be completed via phone or website. Usual clinical procedures will be used to interpret participants' routine screening mammograms, including the use of the breast imaging-reporting and data system (BI-RADS), typically within 1 week of imaging.

Based on their mammography results, women will be placed into two cohorts using their BI-RADS category.

All participants will complete follow-up questionnaires, available in English and Spanish. For the follow-up surveys, the research team will contact participants via their preferred method (text or email) and send a link to the follow-up survey. If unsuccessful, the research team will then contact participants by phone to complete the survey via text or call.

Once mammogram results are available, patients will be randomized 1:1 to either usual care or usual care with chatbot, with randomization in permuted blocks of size and stratified by age (\<55 vs. ≥55 years, a proxy for menopause and indicator of risk); rural/frontier vs. urban; language preference (English vs. Spanish); and cohort (normal vs. abnormal result).

This study will randomly invite participants from four groups for focus group discussions (FGDs) based on their mammogram results and adherence to screening recommendations. This study aim to conduct 8 FGDs (2 per group, one in Spanish and one in English) with 8-10 participants each.

Interventions

• Other Chatbot
  The Chatbot used in this study will be used after mammography to facilitate follow-up, answer patient questions, and provide information.

Primary outcome measures

• Screening Adherence [Time frame: up to 24 months from initiation of study intervention]

Secondary outcome measures (2)

• Receipt of follow-up testing [Time frame: up to 12 months from initiation of study intervention]
• Receipt of episode completion [Time frame: up to 12 months from initiation of study intervention]

Eligibility criteria

Inclusion criteria

• Adult (equal to or above 18 years old)
• English or Spanish speaking
• Visit a mammography program for routine screening.

Exclusion criteria

• Patients who are currently in treatment for breast cancer
• Patients who are not of 18 years of age.
• Patients who don't speak English or Spanish
• Men
• Cognitive limitations that impede informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 1 center

• Huntsman Cancer Institute/ University of Utah — Salt Lake City

Publications

• Cancer Stat Facts: Female Breast Cancer. https://seer.cancer.gov/statfacts/html/breast.html. Accessed Oct 11, 2021.
• American Cancer Society. Cancer Facts & Figures for Hispancis/Latinos 2018-2020. Atlanta: American Cancer Society, Inc.;2018.
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07029490 · HCI185522 · SPA-RFA-Team23-1001996-01-PASD

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗