Clinical trial · Interventional
Intervention to Promote Breast Cancer Screening Among American Indian Women
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Educational mobile app | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Participants are randomized to interventional arm which is seven-day intervention that requires them to download mobile app to complete educational courses each day. Participants are required to complete pre- and post-tests as part of the study. The intervention encourages education on mammogram needs.
- interventionNames
- Behavioral: Educational mobile app
- type
- NO_INTERVENTION
- label
- Control
- description
- Participants are randomized to control arm where they are give an education brochure. There are pre and post tests to complete.
Primary outcomes (1)
- measure
- Number of Participants Who Received a Mammogram
- timeFrame
- Week 24
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDRoh S, Lee YS, Kenyon DB, Elliott AJ, Petereit DG, Gaba A, Lee HY. Mobile Web App Intervention to Promote Breast Cancer Screening Among American Indian Women in the Northern Plains: Feasibility and Efficacy Study. JMIR Form Res. 2023 Jul 20;7:e47851. doi: 10.2196/47851. PMID 37471115