Breast CancerEMPOWERNCT07029490
Enhancing Mammography Programs for Outreach, Wellness, Education, and Resources (EMPOWER) in Underserved Populations Study
A study testing Chatbot in people with Breast Cancer, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Chatbot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,700 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2025to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (equal to or above 18 years old)
- English or Spanish speaking
- Visit a mammography program for routine screening.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Huntsman Cancer Institute/ University of Utah
Salt Lake City, Utah, 84108
Elissa Ozanne, PhD, 801-213-4130, Elissa.Ozanne@hsc.utah.edu
Elissa Ozanne, PhD
About this study
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
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Chatbot
- Keywords
- Mammography, Chatbot, Mobile Mammography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChatbotOther
The Chatbot used in this study will be used after mammography to facilitate follow-up, answer patient questions, and provide information.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Usual Care: This will include participants randomized to usual care. |
| Chatbot | Experimental | Chatbot: This will include participants randomized to usual care with the Chatbot. Receives: Other: Chatbot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening Adherence
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.
Measured: up to 24 months from initiation of study intervention
Secondary outcomes (2)
Receipt of follow-up testing
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.
Measured: up to 12 months from initiation of study intervention
Receipt of episode completion
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.
Measured: up to 12 months from initiation of study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start19 Nov 2025
- Primary completionMar 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029490
- Sponsor's protocol ID
- HCI185522
- Other IDs
- SPA-RFA-Team23-1001996-01-PASD
- Acronym
- EMPOWER
- Status last verified
- Nov 2025
- First submitted
- 11 Jun 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23454732DeSantis 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.
PubMed 28972651Doescher 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.
PubMed 19363399Roche 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.
PubMed 28430705Williams 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.
PubMed 26223824Bennett KJ, Pumkam C, Bellinger JD, Probst JC. Cancer screening delivery in persistent poverty rural counties. J Prim Care Community Health. 2011 Oct 1;2(4):240-9. doi: 10.1177/2150131911406123. Epub 2011 May 17.
PubMed 23804842Bennett KJ, Probst JC, Bellinger JD. Receipt of cancer screening services: surprising results for some rural minorities. J Rural Health. 2012 Jan;28(1):63-72. doi: 10.1111/j.1748-0361.2011.00365.x. Epub 2011 Mar 11.
PubMed 22236316Coughlin SS, Leadbetter S, Richards T, Sabatino SA. Contextual analysis of breast and cervical cancer screening and factors associated with health care access among United States women, 2002. Soc Sci Med. 2008 Jan;66(2):260-75. doi: 10.1016/j.socscimed.2007.09.009. Epub 2007 Nov 19.
PubMed 18022299Horner-Johnson W, Dobbertin K, Iezzoni LI. Disparities in receipt of breast and cervical cancer screening for rural women age 18 to 64 with disabilities. Womens Health Issues. 2015 May-Jun;25(3):246-53. doi: 10.1016/j.whi.2015.02.004. Epub 2015 Apr 9.
PubMed 25864023Leung J, McKenzie S, Martin J, McLaughlin D. Effect of rurality on screening for breast cancer: a systematic review and meta-analysis comparing mammography. Rural Remote Health. 2014;14(2):2730. Epub 2014 Jun 23.
PubMed 24953122Incidence Rates for Utah by County Breast (Late Stage), 2014-2018, All Races (includes Hispanic), Female, All Ages. https://statecancerprofiles.cancer.gov/map/map.withimage.php?49&county&001&055211&00&2&11&0&1&5&0#results. Accessed Oct 11, 2021.
Guillaume E, Launay L, Dejardin O, Bouvier V, Guittet L, Dean P, Notari A, De Mil R, Launoy G. Could mobile mammography reduce social and geographic inequalities in breast cancer screening participation? Prev Med. 2017 Jul;100:84-88. doi: 10.1016/j.ypmed.2017.04.006. Epub 2017 Apr 10.
PubMed 28408217
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Mammography Programs for Outreach, Wellness, Education, and Resources (EMPOWER) in Underserved Populations Study
- ClinicalTrials.gov ID
- NCT07029490
- Acronym / sponsor ID
- EMPOWER / HCI185522
- Conditions
- Breast Cancer
- Keywords
- Mammography, Chatbot, Mobile Mammography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,700 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Usual Care: This will include participants randomized to usual care. |
| Chatbot | Experimental | Other: ChatbotChatbot: This will include participants randomized to usual care with the Chatbot. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (equal to or above 18 years old)
- English or Spanish speaking
- Visit a mammography program for routine screening.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChatbotThe Chatbot used in this study will be used after mammography to facilitate follow-up, answer patient questions, and provide information. | Other | Chatbot |
Primary outcome
Screening Adherence
Time frame: 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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- BackgroundCancer Stat Facts: Female Breast Cancer. https://seer.cancer.gov/statfacts/html/breast.html. Accessed Oct 11, 2021.
- BackgroundAmerican Cancer Society. Cancer Facts & Figures for Hispancis/Latinos 2018-2020. Atlanta: American Cancer Society, Inc.;2018.
- BackgroundDeath 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: PubMed 23454732Henry 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.
- Background: PubMed 28972651DeSantis 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.
- Background: PubMed 19363399Doescher 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.
- Background: PubMed 28430705Roche 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.
- Background: PubMed 26223824Williams 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.
- Background: PubMed 23804842Bennett KJ, Pumkam C, Bellinger JD, Probst JC. Cancer screening delivery in persistent poverty rural counties. J Prim Care Community Health. 2011 Oct 1;2(4):240-9. doi: 10.1177/2150131911406123. Epub 2011 May 17.
- Background: PubMed 22236316Bennett KJ, Probst JC, Bellinger JD. Receipt of cancer screening services: surprising results for some rural minorities. J Rural Health. 2012 Jan;28(1):63-72. doi: 10.1111/j.1748-0361.2011.00365.x. Epub 2011 Mar 11.
- Background: PubMed 18022299Coughlin SS, Leadbetter S, Richards T, Sabatino SA. Contextual analysis of breast and cervical cancer screening and factors associated with health care access among United States women, 2002. Soc Sci Med. 2008 Jan;66(2):260-75. doi: 10.1016/j.socscimed.2007.09.009. Epub 2007 Nov 19.
- Background: PubMed 25864023Horner-Johnson W, Dobbertin K, Iezzoni LI. Disparities in receipt of breast and cervical cancer screening for rural women age 18 to 64 with disabilities. Womens Health Issues. 2015 May-Jun;25(3):246-53. doi: 10.1016/j.whi.2015.02.004. Epub 2015 Apr 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chatbot in people with Breast Cancer, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anthony Ariotti (801-213-6542, anthony.ariotti@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening Adherence (time frame: up to 24 months from initiation of study intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07029490, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.