Breast CancerNCT07858825
Design and Pilot Implementation of a Chatbot to Support Breast Cancer Screening Among Black Women
A study testing Chatbot in people with Breast Cancer, run by University of Washington.
Trial summary
Black women are more likely than White women to be diagnosed at later stages and to die from breast cancer. Increasing breast cancer screening rates could help improve early detection of and survival from breast cancer. Read more about this study
- Who is it for?
- Ages 40 to 74 years, 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
- 873 participants
- Where
- No sites listed yet
- Study dates
- 26 Oct 2026to 1 Jun 2027
- 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 40 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 40 through 74 years at the time of eligibility assessment.
- Assigned female at birth.
- An active UW Medicine primary-care patient and included in the UW Medicine population-health breast cancer screening outreach population.
- Due for breast cancer screening, defined as having no documented mammogram within the prior 24 months, based on the UW Medicine adaptation of the NCQA HEDIS breast cancer screening measure.
- Have a mobile phone number on file and opted in to receiving text messages from UW Medicine.
- Eligible to receive routine breast cancer screening outreach according to UW Medicine clinical and operational criteria.
Who cannot join
- History of bilateral mastectomy.
- EHR diagnosis or indicator of palliative care, advanced illness, or frailty.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Olivia Gregorich, MS contact
About this study
Black women are more likely than White women to be diagnosed at later stages and to die from breast cancer. Increasing breast cancer screening rates could help improve early detection of and survival from breast cancer. To this end, this study seeks to implement and evaluate a culturally tailored chatbot intervention to increase breast cancer screening and address inequities among Black women using community-based research approaches.
We will conduct a pilot randomized quality improvement trial to test the efficacy of a chatbot outreach intervention, which provides breast cancer screening education and direct links to scheduling, on increasing breast cancer screening completion among Black women who receive primary care at the University of Washington (UW) Medicine. We hypothesize that compared to women who receive usual care, women who receive this novel chatbot outreach will have higher breast cancer screening completion rates at 90-days. In addition to quantitative assessment of chatbot effectiveness, we will also qualitatively evaluate chatbot acceptability, feasibility, and message relevance through interviews with a small group of participants about their experiences with the chatbot.
Read the detailed description
Our study purpose is to evaluate the effectiveness of a culturally tailored chatbot intervention to improve access to mammography scheduling and breast cancer screening (BCS) completion among average risk Black women who receive primary care at the University of Washington (UW) and are due for breast cancer screening.
This is a prospective, pilot randomized controlled trial that will evaluate the effectiveness of an outreach strategy in improving BCS completion via mammography. Individuals eligible for enrollment into the trial will be randomized to the two following interventions:
- Arm 1: Chatbot intervention: SMS/text message with breast cancer screening educational and scheduling information; reminder message at 2-weeks.
- Arm 2: Control: usual care.
Random assignments will be based on a randomization scheme called Big Stick Design with a maximum tolerated imbalance between groups of 4. This design allows random assignments to be generated in a way that limits the imbalance between arms within strata, while ensuring that the sequence is not predictable based on previous assignments. Randomization will be stratified within arms by 1) age (40-55 years vs. 56-74 years - to account for potential differences in recommendations for mammogram frequency and comfort with technology/chatbots), 2) history of any prior breast cancer screening (prior screener vs. never screener), 3) campaign messaging status (received UW Medicine Population Health breast cancer screening campaign outreach message in August 2026 vs. did not receive outreach message in August 2026).
We plan to stagger the timing of chatbot outreach based on mammogram access in coordination with the UW radiology department. For example, if there are 20 slots available in the next 2 weeks across sites, we may send chatbot outreach to 100 eligible participants (with expected ~20% response rate to successful outreach interventions among people overdue for screening). If there is a delay between randomization and intervention group chatbot outreach (i.e. due to staggering), we will confirm if participants have scheduled mammography in interim and are therefore no longer eligible for study participation before intervention outreach messaging is sent.
Our primary outcome of interest is proportion of participants who completed BCS at 90 days following initial chatbot outreach. Our secondary outcome of interest is proportion of participants who scheduled or completed BCS at 90 days following initial chatbot outreach (i.e. measuring implementation effectiveness). We will also perform a sensitivity analysis measuring both primary and secondary outcomes at 180 days following initial chatbot outreach (i.e. to account for delays in scheduling/outreach).
We will perform intention-to-treat (ITT) analyses. First, we will use the Pearson's chi-square test of homogeneity to assess for statistically significant differences between randomization group and control group mammogram completion rate at 90 days post chatbot outreach (primary outcome), or mammogram scheduling/completion rate at 90 days post chatbot outreach (secondary outcome). We will then conduct a multivariable logistic regression analysis to test the association between randomization group and mammogram completion at 90 days post chatbot outreach (primary outcome), or mammogram scheduling/completion at 90 days post chatbot outreach (secondary outcome), adjusting for individual- (e.g., age, insurance status, patient portal use, primary care visits in last year, previous BCS), clinic- (e.g., clinic group), and system-level characteristics (e.g. campaigns messaging), including stratification factors, to address covariate imbalance between groups and improve precision in the analysis. We will estimate adjusted risk differences from these models using predictive margins.
Finally, we will conduct unadjusted exploratory subgroup analyses. We will explore intervention effect consistency between: 1) participants who use the patient portal and those who do not use the patient portal; 2) participants who receive primary care through a university hospital-based clinic, county hospital-based clinic, or community-based clinic; 3) among intervention group participants who responded to text messages and/or reached scheduling message (i.e. interacted with chatbot) vs. those who did not.
- Conditions
- Breast Cancer
- Being tested
- Chatbot
- Keywords
- chatbot, breast cancer screening, mammogram, text message
- 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
Chatbot-based outreach that provides breast cancer screening education, allows participants to learn more about screening, and offers direct mammography scheduling through the chatbot
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Patients in this arm may receive breast cancer screening counseling and/or mammogram referral through usual primary care. This could include during primary care visit, patient portal message, phone call or letter. |
| Chatbot intervention | Experimental | Initial chatbot outreach with education and direct mammogram scheduling capability, with one conditional follow-up message at approximately Day 14 Receives: Other: Chatbot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants completing BCS 90 days after initial outreach
Measured: 90-days
Secondary outcomes (1)
Proportion of participants who schedule or complete BCS 90 days after initial outreach
Measured: 90-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start26 Oct 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 WashingtonThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 873 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals, National Comprehensive Cancer Network
- Responsible party
- Principal investigator, Leah Marcotte, University of Washington
- Investigators
- Leah Marcotte, MD, MS, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858825
- Sponsor's protocol ID
- STUDY00025853
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marcotte LM, Deeds S, Wheat C, Gunnink E, Gray K, Rojas J, Finch C, Nelson K, Reddy A. Automated Opt-Out vs Opt-In Patient Outreach Strategies for Breast Cancer Screening: A Randomized Clinical Trial. JAMA Intern Med. 2023 Nov 1;183(11):1187-1194. doi: 10.1001/jamainternmed.2023.4321.
PubMed 37695621Marcotte LM, Khor S, Wong ES, Akinsoto N, Lee ES, Onstad S, Issaka RB. A Pilot Analysis of Patient Portal Use and Breast Cancer Screening Among Black Patients in a Large Academic Health System. AJPM Focus. 2024 Nov 22;4(1):100305. doi: 10.1016/j.focus.2024.100305. eCollection 2025 Feb.
PubMed 39866156Marcotte LM, Langevin R, Hempstead BH, Ganguly A, Lyon AR, Weiner BJ, Akinsoto N, Houston PL, Fang V, Hsieh G. Leveraging human-centered design and causal pathway diagramming toward enhanced specification and development of innovative implementation strategies: a case example of an outreach tool to address racial inequities in breast cancer screening. Implement Sci Commun. 2024 Mar 28;5(1):31. doi: 10.1186/s43058-024-00569-w.
PubMed 38549174Marcotte LM, Khor S, Reddy A, Morenz A, Nelson K, Akinsoto N, Lee ES, Onstad S, Wong ES. An analysis of multilevel factor contributions to breast cancer screening inequities in an academic health system. Cancer. 2025 Feb 1;131(3):e35734. doi: 10.1002/cncr.35734.
PubMed 39865423
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Pilot Implementation of a Chatbot to Support Breast Cancer Screening Among Black Women
- ClinicalTrials.gov ID
- NCT07858825
- Acronym / sponsor ID
- STUDY00025853
- Conditions
- Breast Cancer
- Keywords
- chatbot, breast cancer screening, mammogram, text message
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 873 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals, National Comprehensive Cancer Network
- Study start
- 26 Oct 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 5 Oct 2026 (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.
Black women are more likely than White women to be diagnosed at later stages and to die from breast cancer. Increasing breast cancer screening rates could help improve early detection of and survival from breast cancer. To this end, this study seeks to implement and evaluate a culturally tailored chatbot intervention to increase breast cancer screening and address inequities among Black women using community-based research approaches.
We will conduct a pilot randomized quality improvement trial to test the efficacy of a chatbot outreach intervention, which provides breast cancer screening education and direct links to scheduling, on increasing breast cancer screening completion among Black women who receive primary care at the University of Washington (UW) Medicine. We hypothesize that compared to women who receive usual care, women who receive this novel chatbot outreach will have higher breast cancer screening completion rates at 90-days. In addition to quantitative assessment of chatbot effectiveness, we will also qualitatively evaluate chatbot acceptability, feasibility, and message relevance through interviews with a small group of participants about their experiences with the chatbot.
Detailed description
Our study purpose is to evaluate the effectiveness of a culturally tailored chatbot intervention to improve access to mammography scheduling and breast cancer screening (BCS) completion among average risk Black women who receive primary care at the University of Washington (UW) and are due for breast cancer screening.
This is a prospective, pilot randomized controlled trial that will evaluate the effectiveness of an outreach strategy in improving BCS completion via mammography. Individuals eligible for enrollment into the trial will be randomized to the two following interventions:
- Arm 1: Chatbot intervention: SMS/text message with breast cancer screening educational and scheduling information; reminder message at 2-weeks.
- Arm 2: Control: usual care.
Random assignments will be based on a randomization scheme called Big Stick Design with a maximum tolerated imbalance between groups of 4. This design allows random assignments to be generated in a way that limits the imbalance between arms within strata, while ensuring that the sequence is not predictable based on previous assignments. Randomization will be stratified within arms by 1) age (40-55 years vs. 56-74 years - to account for potential differences in recommendations for mammogram frequency and comfort with technology/chatbots), 2) history of any prior breast cancer screening (prior screener vs. never screener), 3) campaign messaging status (received UW Medicine Population Health breast cancer screening campaign outreach message in August 2026 vs. did not receive outreach message in August 2026).
We plan to stagger the timing of chatbot outreach based on mammogram access in coordination with the UW radiology department. For example, if there are 20 slots available in the next 2 weeks across sites, we may send chatbot outreach to 100 eligible participants (with expected ~20% response rate to successful outreach interventions among people overdue for screening). If there is a delay between randomization and intervention group chatbot outreach (i.e. due to staggering), we will confirm if participants have scheduled mammography in interim and are therefore no longer eligible for study participation before intervention outreach messaging is sent.
Our primary outcome of interest is proportion of participants who completed BCS at 90 days following initial chatbot outreach. Our secondary outcome of interest is proportion of participants who scheduled or completed BCS at 90 days following initial chatbot outreach (i.e. measuring implementation effectiveness). We will also perform a sensitivity analysis measuring both primary and secondary outcomes at 180 days following initial chatbot outreach (i.e. to account for delays in scheduling/outreach).
We will perform intention-to-treat (ITT) analyses. First, we will use the Pearson's chi-square test of homogeneity to assess for statistically significant differences between randomization group and control group mammogram completion rate at 90 days post chatbot outreach (primary outcome), or mammogram scheduling/completion rate at 90 days post chatbot outreach (secondary outcome). We will then conduct a multivariable logistic regression analysis to test the association between randomization group and mammogram completion at 90 days post chatbot outreach (primary outcome), or mammogram scheduling/completion at 90 days post chatbot outreach (secondary outcome), adjusting for individual- (e.g., age, insurance status, patient portal use, primary care visits in last year, previous BCS), clinic- (e.g., clinic group), and system-level characteristics (e.g. campaigns messaging), including stratification factors, to address covariate imbalance between groups and improve precision in the analysis. We will estimate adjusted risk differences from these models using predictive margins.
Finally, we will conduct unadjusted exploratory subgroup analyses. We will explore intervention effect consistency between: 1) participants who use the patient portal and those who do not use the patient portal; 2) participants who receive primary care through a university hospital-based clinic, county hospital-based clinic, or community-based clinic; 3) among intervention group participants who responded to text messages and/or reached scheduling message (i.e. interacted with chatbot) vs. those who did not.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Patients in this arm may receive breast cancer screening counseling and/or mammogram referral through usual primary care. This could include during primary care visit, patient portal message, phone call or letter. |
| Chatbot intervention | Experimental | Other: ChatbotInitial chatbot outreach with education and direct mammogram scheduling capability, with one conditional follow-up message at approximately Day 14 |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 40 through 74 years at the time of eligibility assessment.
- Assigned female at birth.
- An active UW Medicine primary-care patient and included in the UW Medicine population-health breast cancer screening outreach population.
- Due for breast cancer screening, defined as having no documented mammogram within the prior 24 months, based on the UW Medicine adaptation of the NCQA HEDIS breast cancer screening measure.
- Have a mobile phone number on file and opted in to receiving text messages from UW Medicine.
Key exclusion criteria (2 listed)
- History of bilateral mastectomy.
- EHR diagnosis or indicator of palliative care, advanced illness, or frailty.
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 |
|---|---|---|
| ChatbotChatbot-based outreach that provides breast cancer screening education, allows participants to learn more about screening, and offers direct mammography scheduling through the chatbot | Other | Chatbot intervention |
Primary outcome
Proportion of participants completing BCS 90 days after initial outreach
Time frame: 90-days
1 secondary outcome
Proportion of participants who schedule or complete BCS 90 days after initial outreach
Time frame: 90-days
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 5 Oct 2026.
- Background: PubMed 37695621Marcotte LM, Deeds S, Wheat C, Gunnink E, Gray K, Rojas J, Finch C, Nelson K, Reddy A. Automated Opt-Out vs Opt-In Patient Outreach Strategies for Breast Cancer Screening: A Randomized Clinical Trial. JAMA Intern Med. 2023 Nov 1;183(11):1187-1194. doi: 10.1001/jamainternmed.2023.4321.
- Background: PubMed 39866156Marcotte LM, Khor S, Wong ES, Akinsoto N, Lee ES, Onstad S, Issaka RB. A Pilot Analysis of Patient Portal Use and Breast Cancer Screening Among Black Patients in a Large Academic Health System. AJPM Focus. 2024 Nov 22;4(1):100305. doi: 10.1016/j.focus.2024.100305. eCollection 2025 Feb.
- Background: PubMed 38549174Marcotte LM, Langevin R, Hempstead BH, Ganguly A, Lyon AR, Weiner BJ, Akinsoto N, Houston PL, Fang V, Hsieh G. Leveraging human-centered design and causal pathway diagramming toward enhanced specification and development of innovative implementation strategies: a case example of an outreach tool to address racial inequities in breast cancer screening. Implement Sci Commun. 2024 Mar 28;5(1):31. doi: 10.1186/s43058-024-00569-w.
- Background: PubMed 39865423Marcotte LM, Khor S, Reddy A, Morenz A, Nelson K, Akinsoto N, Lee ES, Onstad S, Wong ES. An analysis of multilevel factor contributions to breast cancer screening inequities in an academic health system. Cancer. 2025 Feb 1;131(3):e35734. doi: 10.1002/cncr.35734.
- 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.
Olivia Gregorich, MS contact
Leah Marcotte, MD, MS principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A study testing Chatbot in people with Breast Cancer, run by University of Washington.
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 6 inclusion and 2 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: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Leah Marcotte, MD, MS (206-598-8750, leahmar@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants completing BCS 90 days after initial outreach (time frame: 90-days). 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 NCT07858825, which also lists 4 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 5 Oct 2026.