CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 133 enrolled
Drug / intervention
Educational mobile appbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05530603
NCT05530603N/ACompleted

Intervention to Promote Breast Cancer Screening Among American Indian Women

University of South Dakota·interventional·Posted Sep 7, 2022·Updated Mar 17, 2025

In Brief

A clinical study evaluating Educational mobile app for Breast Cancer. Completed, enrolled 133 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedSep 7, 2022
Enrollment StartOct 3, 2020
Primary CompletionJul 31, 2023
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 3.8 years ago

Interventions

Educational mobile appbehavioral

7 day educational course to educate American Indian women to receive regular mammogram.