Mammography Education for Breast Cancer

Overseen By Katie Nelson, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Johns Hopkins Bloomberg School of Public Health

Disqualifiers: Non-AIAN, Male, Age, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What makes the TEAM treatment for improving mammography acceptance unique?

The TEAM treatment is unique because it uses tablet-based education, potentially combined with navigation support, to improve acceptance of mammography. This approach addresses barriers like lack of understanding and anxiety by providing accessible, interactive information, which is different from traditional methods that rely on brochures or verbal instructions. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Tablet-based Education to improve the Acceptance of Mammography (TEAM) and TEAM + Navigation?

Research shows that patient navigation (helping patients through the healthcare system) can improve adherence to mammography screening, especially in vulnerable populations. Additionally, educational tools like decision aids have been shown to increase informed choices about breast cancer screening without reducing participation. ^{6 7 8 9 10}

Who Is on the Research Team?

Katie Nelson, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for Native American women in a specific community on the Navajo Nation who are due for breast cancer screening. It aims to improve mammography rates using culturally-tailored education and support.

Inclusion Criteria

Willing to be randomized

Self-identify as American Indian or Alaska Native (AIAN)

Are a registered patient at Chinle Comprehensive HealthCare Facility (CCHFC)

Exclusion Criteria

Do not self-identify as American Indian or Alaska Native (AIAN)

Are not a registered patient at CCHCF

Do not live within 80 miles of CCHCF

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive TEAM or TEAM + Navigation intervention to promote mammography acceptance

3 months

Monthly 1:1 support sessions

Follow-up

Participants are monitored for mammography uptake and effectiveness of the intervention

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Tablet-based Education to improve the Acceptance of Mammography (TEAM)
• Tablet-based Education to improve the Acceptance of Mammography (TEAM) + Navigation

Trial Overview The study compares two approaches: one group receives tablet-based education (TEAM) about mammography, while the other gets TEAM plus monthly personal support from a Diné peer-navigator (TEAM + Navigation).

How Is the Trial Designed?

Group I: TEAM + Navigation Experimental Treatment 2 Interventions

TEAM (Tablet-based Education to improve the Acceptance of Mammography) and Navigation (provision of 1:1 support from a Diné peer-navigator)

Group II: TEAM Active Control 1 Intervention

TEAM (Tablet-based Education to improve the Acceptance of Mammography)

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

Genentech Foundation

Collaborator

Published Research Related to This Trial

The Outcomes4Me mobile app was successfully integrated into routine breast cancer care, with 60% of the 107 patients engaging with it at least three times over a 12-week period, surpassing the feasibility target of 40%.

Patients reported that the app improved their ability to track symptoms and increased their interest in clinical trial enrollment, indicating potential benefits for patient education and decision-making in breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of introducing a smartphone navigation application into the care of breast cancer patients (The FIONA Study). Isakoff, SJ., Said, MR., Kwak, AH., et al.[2023]

Patient navigation (PN) was successfully implemented in resident clinics, leading to a significant increase in biennial screening mammography adherence among patients, particularly in vulnerable populations.

Residents expressed satisfaction with the PN process and showed interest in continuing its use, indicating that PN is a feasible and effective intervention in improving cancer screening rates in these settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of patient navigation in resident primary care practice: a screening mammography quality improvement initiative. Shroff, S., McCoy, ME., Sherman, BJ., et al.[2016]

A tailored web-based educational program for radiologists showed a 12% increase in the odds of positive mammographic results shortly after the intervention, suggesting some potential efficacy in improving screening outcomes.

However, the overall impact on reducing excessive recall rates was not statistically significant, indicating that a single 1-hour intervention may not be sufficient to effect lasting change in radiologists' practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of an educational intervention designed to reduce unnecessary recall during screening mammography. Carney, PA., Abraham, L., Cook, A., et al.[2021]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Feasibility of introducing a smartphone navigation application into the care of breast cancer patients (The FIONA Study). [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Patient-Centered Radiology Reporting: Using Online Crowdsourcing to Assess the Effectiveness of a Web-Based Interactive Radiology Report. [2018]

3. Italy pubmed.ncbi.nlm.nih.gov

["Donnainformata-mammografia": a decision aid developed and validated in the Italian setting]. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Feasibility of patient navigation in resident primary care practice: a screening mammography quality improvement initiative. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Impact of an educational intervention designed to reduce unnecessary recall during screening mammography. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Current use and how to increase mammography screening in women. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Challenges of the Underserved and Underscreened in Mammography. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Mammography screening: successes and problems in implementing widespread use in the United States. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Barriers to screening for breast cancer. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Improving the adherence of urban women to mammography guidelines: strategies for radiologists. [2021]