Breast CancerNCT05665660
Developing and Evaluating Culturally Relevant Interventions to Improve Breast Cancer Screening
A study testing CARE and CARE + COACH 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 relative benefits of an intervention to promote breast cancer screening among women in the White Mountain Apache (WMA) community. Women will be randomized to receive CARE, a culturally tailored mammography education module, or CARE+COACH, which is the CARE education module… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- CARE and CARE + COACH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2023to 20 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Referral for screening mammography from a Whiteriver Indian Health Service provider
- Self-identify as American Indian or Alaska Native (AIAN)
- Female
- Live on within 60 miles of the Fort Apache Indian Reservation
Who cannot join
- Women who have received a mammogram within the prior 12 months
- Women with a personal history of breast cancer
- Unable to participate in full intervention or evaluation due to an anticipated event (e.g., planned move)
- Unwilling to be randomized
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Indigenous Health
Whiteriver, Arizona, 85941
About this study
Official title: Developing and Evaluating Scalable and Culturally Relevant Interventions to Improve Breast Cancer Screening Among White Mountain Apache Women
The goal of this study is to evaluate the relative benefits of an intervention to promote breast cancer screening among women in the White Mountain Apache (WMA) community. Women will be randomized to receive CARE, a culturally tailored mammography education module, or CARE+COACH, which is the CARE education module plus access to an Apache paraprofessional women's health coach (i.e., patient navigator). The CARE intervention was developed through a community-based participatory research process. The primary outcome is mammography uptake within 2 months of a referral.
- Conditions
- Breast Cancer
- Being tested
- CARE, CARE + COACH
- Keywords
- mammography, cancer screening
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAREBehavioural
CARE is a culturally tailored mammography education module.
CARE + COACHBehavioural
CARE + COACH is a culturally tailored mammography education module + access to an Apache paraprofessional women's health coach who functions as a patient navigator
| Study group | Role | What they receive |
|---|---|---|
| CARE - Intervention arm for mammography education | Experimental | CARE is a culturally tailored mammography education module. Receives: Behavioral: CARE |
| CARE + COACH - Intervention arm for mammography education + a patient navigator | Experimental | CARE + COACH is the CARE education module in addition to a COACH, which is access to an Apache paraprofessional women's health coach. The Coach functions like a patient navigator. Receives: Behavioral: CARE + COACH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mammography uptake
Mammography uptake within 2 months of referral
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start6 Jun 2023
- Primary completion26 Sep 2025
- Study completion20 Oct 2025
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.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Women randomized to receive CARE who have not received a mammography at 3 months will be offered CARE+COACH to facilitate completion of their screening and contacted at 4 months.
- Masking
- None (open label)
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Native American Research Center for Health
- Responsible party
- Sponsor
- Investigators
- Allison Barlow, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665660
- Sponsor's protocol ID
- IRB00022667
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2022
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Evaluating Scalable and Culturally Relevant Interventions to Improve Breast Cancer Screening Among White Mountain Apache Women
- ClinicalTrials.gov ID
- NCT05665660
- Acronym / sponsor ID
- IRB00022667
- Conditions
- Breast Cancer
- Keywords
- mammography, cancer screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Native American Research Center for Health
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 26 Sep 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 27 Dec 2022 (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 relative benefits of an intervention to promote breast cancer screening among women in the White Mountain Apache (WMA) community. Women will be randomized to receive CARE, a culturally tailored mammography education module, or CARE+COACH, which is the CARE education module plus access to an Apache paraprofessional women's health coach (i.e., patient navigator). The CARE intervention was developed through a community-based participatory research process. The primary outcome is mammography uptake within 2 months of a referral.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Women randomized to receive CARE who have not received a mammography at 3 months will be offered CARE+COACH to facilitate completion of their screening and contacted at 4 months.
| Arm | Type | Receives |
|---|---|---|
| CARE - Intervention arm for mammography education | Experimental | Behavioral: CARECARE is a culturally tailored mammography education module. |
| CARE + COACH - Intervention arm for mammography education + a patient navigator | Experimental | Behavioral: CARE + COACHCARE + COACH is the CARE education module in addition to a COACH, which is access to an Apache paraprofessional women's health coach. The Coach functions like a patient navigator. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Referral for screening mammography from a Whiteriver Indian Health Service provider
- Self-identify as American Indian or Alaska Native (AIAN)
- Female
- Live on within 60 miles of the Fort Apache Indian Reservation
Key exclusion criteria (4 listed)
- Women who have received a mammogram within the prior 12 months
- Women with a personal history of breast cancer
- Unable to participate in full intervention or evaluation due to an anticipated event (e.g., planned move)
- Unwilling to be randomized
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 |
|---|---|---|
| CARECARE is a culturally tailored mammography education module. | Behavioural | CARE - Intervention arm for mammography education |
| CARE + COACHCARE + COACH is a culturally tailored mammography education module + access to an Apache paraprofessional women's health coach who functions as a patient navigator | Behavioural | CARE + COACH - Intervention arm for mammography education + a patient navigator |
Primary outcome
Mammography uptake
Time frame: 2 months
Mammography uptake within 2 months of referral
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
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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. This study is not recruiting at the moment.
Allison Barlow, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CARE and CARE + COACH 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 24 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mammography uptake (time frame: 2 months). 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 24 Dec 2025.