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

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer

• Registration Number: NCT07029490
• Lead Sponsor: University of Utah

Brief Summary

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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-11
• Study First Submitted QC: 2025-06-11
• Study First Posted: 2025-06-19
• Last Update Submitted: 2025-06-27
• Last Update Posted: 2025-07-02
• Study Start: 2025-09-01
• Primary Completion: 2028-03-30
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 2700

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Screening Adherence	up to 24 months from initiation of study intervention	This outcome measure will test the addition of virtual navigation to usual processes of care to increase screening adherence for underserved women undergoing mobile mammography who have an abnormal breast cancer screening exam.; Screening adherence will be measured as a two-point survey item (Yes/No). This outcome measure will report the proportion of participants who self-reported screening adherence.

Secondary Outcome Measures

Name	Time	Method
Receipt of follow-up testing	up to 12 months from initiation of study intervention	This outcome measure will test the addition of virtual navigation to usual processes of care to increase follow-up testing for underserved women undergoing mobile mammography who have an abnormal breast cancer screening exam.; Receipt of follow-up testing will be measured as survey items. For subjects who were recommended to have additional breast imaging or a breast biopsy, this will report if they completed the recommendation.; This outcome measure will report the proportion of individuals who received all recommended follow-up tests after an initial breast screening indicating additional breast imaging or biopsy.
Receipt of episode completion	up to 12 months from initiation of study intervention	This outcome measure will test the addition of virtual navigation to usual processes of care to increase episode completion for underserved women undergoing mobile mammography who have an abnormal breast cancer screening exam.; Receipt of episode completion will be measured through a survey. This outcome measure will report the proportion of subjects who complete all recommended follow-up steps after initial breast cancer screening or diagnosis, including imaging, biopsy, specialist appointments, and initiation of treatment if applicable.