N/A
Completed N=133
Intervention to Promote Breast Cancer Screening Among American Indian Women
Source: ClinicalTrials.gov NCT05530603 ↗Enrolled (actual)
133
Serious AEs
—
Results posted
Mar 2025
Primary outcomePrimary: Number of Participants Who Received a Mammogram — 26; 12 Participants — p=.009
Summary
Our objectives in this project are to develop and evaluate the feasibility and effectiveness of the Mobile Web App Breast Cancer Screening (wMammogram) intervention that is culturally tailored for AI women residing in rural areas. The proposed study will be a multi-method, two-phase research project that will take place in South Dakota over a three-year period. The two phases are: (1) developing the wMammogram intervention and (2) evaluating the feasibility and efficacy of the wMammogram. Phase 1 incorporates a community-based participatory research approach and a series of focus groups with various stakeholders in American Indian (AI) communities to design a culturally informed and practically refined intervention. Phase 2 uses a randomized clinical trial (RCT) design with AI women. The wMammogram intervention will be applied throughout a seven-day period, with assessment at three intervals: baseline (survey), one-week post-intervention (survey), and six-month follow-up (telephone survey).
The wMammogram intervention will be implemented with AI women using the two-arm RCT that includes recruiting a total of 120 AI women aged 40 to 70 years and randomly assigning them to either (a) the wMammogram intervention group (n=60) to receive culturally and personally tailored multilevel and multimedia messages through a Mobile Web App along with health navigator services or (b) the control group (n=60) to receive the mailing of printed educational materials on breast cancer and relevant screening guidelines along with health navigator services.
Hypotheses: In assessing the efficacy and feasibility of the wMammogram, Investigators hypothesize that:
(H1)The wMammogram intervention participants will show a higher rate of mammograms received than will participants in the educational materials intervention.
(H2)The wMammogram intervention participants will show improvements in knowledge, attitude, and beliefs about breast cancer screening and readiness for mammography as compared to participants in the educational materials intervention.
(H3)The wMammogram intervention participants will demonstrate greater satisfaction with and acceptance of the intervention than would participants in the educational materials intervention.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Received a Mammogram |
26; 12 | .009 sig |
| SECONDARY Change in Participants' Breast Cancer Knowledge Levels From Baseline to Week 1 |
22.95; 21.83 | 0.730 |
| SECONDARY Health Beliefs |
10.19; 9.95 | .033 sig |
| SECONDARY Cultural Attitudes |
11.85; 12.60 | .068 |
| SECONDARY Number of Participants Who Intended to Receive a Mammogram in the Future |
62; 51 | .001 sig |
| SECONDARY Number of Participants Satisfied With Intervention |
60; 53 | .001 sig |
| SECONDARY Number of Participants Indicating Intervention Was Effective/Very Effective |
62; 55 | .001 sig |
Eligibility Criteria
Inclusion Criteria
- Women who are self-identified AI women of the YST in SD
- Women who are aged 40 to 70 years
- Women who have not received a mammogram in the past two years
- Women who are willing to use their own mobile phone, iPad, tablets, and computers, or a mobile phone borrowed from the research team for the wMammogram intervention.
Exclusion Criteria
- Women who received a mammogram in the past year
- Women who are under 40 or over 70 years of age.
Data sourced from ClinicalTrials.gov (NCT05530603). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.