NCT05530603

Intervention to Promote Breast Cancer Screening Among American Indian Women

Completed NA Results posted Last updated 17 March 2025

What this trial tests

NA trial testing Educational mobile app in Breast Cancer in 133 participants. Completed in 31 July 2023.

Timeline

3 October 2020

Primary endpoint
31 July 2023

31 July 2023

Quick facts

Lead sponsor	University of South Dakota
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	133
Start date	3 October 2020
Primary completion	31 July 2023
Estimated completion	31 July 2023
Sites	2 locations across United States

Drugs / interventions tested

• Educational mobile app

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

University of South Dakota

Who can join

Adults 40 to 70, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Received a Mammogram Primary · Week 24

This outcome was assessed based on the number of participants who reported having received a mammogram during the six-month follow-up survey. The survey asked participants, "Have you ever received a mammogram since you had participated in a mammogram intervention?" Participants could respond with either "Yes, I have received one" or "No, I haven't received one yet." We calculated and compared the number of participants from each arm who received mammograms after the intervention.

Group	Value	95% CI
Intervention	26
Control	12

Change in Participants' Breast Cancer Knowledge Levels From Baseline to Week 1 Secondary · Baseline and Week 1

Participants' breast cancer knowledge levels were assessed using the Breast Cancer Knowledge Test, which includes 28 true- or false-items. Scores were determined by the number of correct responses, with the total score ranging from 0 to 28. Higher scores indicate greater breast cancer knowledge, with a score of 0 reflecting no knowledge and a score of 28 indicating very high knowledge. The test was updated to align with the latest American Cancer Society breast cancer screening guideline. Change = (Week 1 Score - Baseline Score).

Group	Value	95% CI
Intervention	22.95	± 4.58
Control	21.83	± 4.52

Health Beliefs Secondary · 7 days

Participants' health beliefs were assessed using a 5-item prevention orientation scale at one week post-intervention. The scale included items, such as "Even if I do not have a family history of cancer, it is important to be checked regularly," and "It is better to detect health problems early through screening efforts than discover something later and have to treat it." Each item was rated on a 4-point Likert scale, ranging from "1=strongly disagree" to "4=strongly agree." Scores for each item were calculated by summing the item responses, with total scores ranging from 5 to 20. Higher item s

Group	Value	95% CI
Intervention	10.19	± 1.678
Control	9.95	± 1.692

Cultural Attitudes Secondary · 7 days

Cultural attitudes toward breast cancer screening were assessed using a 6-items cultural modesty scale. Each item was rated on a 4-point scale, ranging from "1=strongly disagree" to "4=strongly agree." Higher item scores indicated stronger belief in cultural modesty. The total score for each item was computed by summing the individual item scores, ranging from 6 to 24.

Group	Value	95% CI
Intervention	11.85	± 3.067
Control	12.60	± 3.509

Number of Participants Who Intended to Receive a Mammogram in the Future Secondary · 7 days

Number of Participants who intended to receive a mammogram in the future was assessed by a single question at both baseline and 1 week after the intervention. The single question asked whether a participant intended to receive a mammogram in the future, with response options of "0=No intention" or "1=Yes intention." The data values represent the number of participants who intended to receive a mammogram in the future with the response of "Yes intention."

Group	Value	95% CI
Intervention	62
Control	51

Number of Participants Satisfied With Intervention Secondary · 7 days

Number of participants satisfied with intervention they received was assessed using a 2-point scale ranging from "1=Dissatisfied/Very dissatisfied" to "2=Satisfied/Very Satisfied" one week after the intervention. The data values represent the number of participants satisfied with intervention with response option of "2=Satisfied/Very Satisfied."

Group	Value	95% CI
Intervention	60
Control	53

Number of Participants Indicating Intervention Was Effective/Very Effective Secondary · 7 days

Number of Participants Indicating Intervention Was Effective/Very Effective was measured one week after the intervention with the question, "Do you think that the intervention you received was effective in increasing your knowledge of breast cancer and screenings?" Participants responded on a 4-point scale item ranging from "1=very ineffectual" to "4=very effectual." The data values represent the number of participants who indicated the intervention was "3 = Effective" or "4 = Very Effective."

Group	Value	95% CI
Intervention	62
Control	55

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Mobile Web App Intervention to Promote Breast Cancer Screening Among American Indian Women in the Northern Plains: Feasibility and Efficacy Study.
   Roh S, Lee YS, Kenyon DB, Elliott AJ, et al · · 2023 · cited 8× · PMID 37471115 · DOI 10.2196/47851