Breast CancerNCT06957535
Community-led Navigation to Address Disparities in Mammography Among Native American Women
A study testing Navigation and TEAM in people with Breast Cancer, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
The goal of this study is to evaluate the effectiveness of an intervention to promote breast cancer screening mammography among women in one community on the Navajo Nation. The intervention is Tablet-based Education to improve the Acceptance of Mammography (TEAM). Read more about this study
- Who is it for?
- Ages 40 to 74 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Navigation and TEAM
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2025to Mar 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 40 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identify as American Indian or Alaska Native (AIAN)
- Identify as Female
- Are 40-74 years of age
- Are a registered patient at Chinle Comprehensive HealthCare Facility (CCHFC)
- Live within 80 miles of CCHFC
- Have not received a mammogram within the prior 12 months
Show all 9Show fewer
- Do not have a personal history of breast cancer
- Are not planning to move in the next 6 months
- Willing to be randomized
Who cannot join
- Do not self-identify as American Indian or Alaska Native (AIAN)
- Do not identify as Female
- Are not 40-74 years of age
- Are not a registered patient at CCHCF
- Do not live within 80 miles of CCHCF
- Have received a mammogram within the prior 12 months
Show all 9Show fewer
- Have a personal history of breast cancer
- Are planning to move in the next 6 months
- Unwilling to be randomized
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
Navajo Nation Center for Indigenous Health
Chinle, Arizona, 86503
Kristen Mitchell, MS, 928-674-5051
About this study
The goal of this study is to evaluate the effectiveness of an intervention to promote breast cancer screening mammography among women in one community on the Navajo Nation. The intervention is Tablet-based Education to improve the Acceptance of Mammography (TEAM). TEAM encompasses culturally-tailored mammography education modules that were developed using a community-based participatory research process. Women will be randomized to receive TEAM or TEAM + Navigation. Navigation involves monthly 1:1 support from a Diné peer-navigator.
- Conditions
- Breast Cancer
- Being tested
- Navigation, TEAM
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NavigationBehavioural
Navigation is provision of 1:1 support from a Diné peer-navigator
TEAMBehavioural
TEAM encompasses culturally tailored mammography education modules
| Study group | Role | What they receive |
|---|---|---|
| TEAM | Active comparator | TEAM (Tablet-based Education to improve the Acceptance of Mammography) Receives: Behavioral: TEAM |
| TEAM + Navigation | Experimental | TEAM (Tablet-based Education to improve the Acceptance of Mammography) and Navigation (provision of 1:1 support from a Diné peer-navigator) Receives: Behavioral: Navigation; Behavioral: TEAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with mammography
Mammography uptake within 3 months of referral
Measured: 3 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start2 Oct 2025
- Primary completionAug 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech Foundation
- Responsible party
- Sponsor
- Investigators
- Katie Nelson, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957535
- Sponsor's protocol ID
- IRB00031873
- Status last verified
- Oct 2026
- First submitted
- 25 Apr 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-led Navigation to Address Disparities in Mammography Among Native American Women
- ClinicalTrials.gov ID
- NCT06957535
- Acronym / sponsor ID
- IRB00031873
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Genentech Foundation
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 4 May 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.
The goal of this study is to evaluate the effectiveness of an intervention to promote breast cancer screening mammography among women in one community on the Navajo Nation. The intervention is Tablet-based Education to improve the Acceptance of Mammography (TEAM). TEAM encompasses culturally-tailored mammography education modules that were developed using a community-based participatory research process. Women will be randomized to receive TEAM or TEAM + Navigation. Navigation involves monthly 1:1 support from a Diné peer-navigator.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEAM | Active comparator | Behavioral: TEAMTEAM (Tablet-based Education to improve the Acceptance of Mammography) |
| TEAM + Navigation | Experimental | Behavioral: Navigation, Behavioral: TEAMTEAM (Tablet-based Education to improve the Acceptance of Mammography) and Navigation (provision of 1:1 support from a Diné peer-navigator) |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Self-identify as American Indian or Alaska Native (AIAN)
- Identify as Female
- Are 40-74 years of age
- Are a registered patient at Chinle Comprehensive HealthCare Facility (CCHFC)
- Live within 80 miles of CCHFC
Key exclusion criteria (9 listed)
- Do not self-identify as American Indian or Alaska Native (AIAN)
- Do not identify as Female
- Are not 40-74 years of age
- Are not a registered patient at CCHCF
- Do not live within 80 miles of CCHCF
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 |
|---|---|---|
| NavigationNavigation is provision of 1:1 support from a Diné peer-navigator | Behavioural | TEAM + Navigation |
| TEAMTEAM encompasses culturally tailored mammography education modules | Behavioural | TEAM, TEAM + Navigation |
Primary outcome
Number of participants with mammography
Time frame: 3 months post baseline
Mammography uptake within 3 months of referral
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 13 Oct 2026.
- 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.
Katie Nelson, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigation and TEAM in people with Breast Cancer, run by Johns Hopkins Bloomberg School of Public Health 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 9 inclusion and 9 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 13 Oct 2026. 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 Katie Nelson, PhD (410-955-6931, knelso46@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with mammography (time frame: 3 months post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2026.