Intervention to Promote Breast Cancer Screening Among American Indian Women

NCT05530603 | Completed Results

• 2 other identifiers: 2019-053U54GM128729
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Received a Mammogram

  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.

  Week 24

Secondary Outcomes (6)

• Change in Participants' Breast Cancer Knowledge Levels From Baseline to Week 1

  Baseline and Week 1

• Health Beliefs

  7 days

• Cultural Attitudes

  7 days

• Number of Participants Who Intended to Receive a Mammogram in the Future

  7 days

• Number of Participants Satisfied With Intervention

  7 days

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Educational mobile app

Control

NO INTERVENTION

Participants are randomized to control arm where they are give an education brochure. There are pre and post tests to complete.

Interventions

Educational mobile app BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Women who received a mammogram in the past year
• Women who are under 40 or over 70 years of age.

Sponsors & Collaborators

• University of South Dakota: lead
• University of North Dakota: collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (2)

Yankton Sioux Tribe

Lake Andes, South Dakota, 57356, United States

Location

University of South Dakota

Vermillion, South Dakota, 57069, United States

Location

Related Publications (1)

• Roh 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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Research within a single tribe, like the Yankton Sioux Tribe, offers valuable insights into that community's unique dynamics. However, these findings cannot be broadly generalized. Each tribe has distinct traditions, languages, and community structures that shape health behaviors and outcomes, making cross-tribal generalization challenging.

Results Point of Contact

• Title: Soonhee Roh
• Organization: University of South Dakota

Soonhee.Roh@usd.edu

6053571593

Study Officials

• SOONHEE ROH, PhD

  University of South Dakota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are unaware of which group they have been assigned to.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 2 arms randomized clinical trial with control and intervention group

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 7, 2022
• Study Start: October 3, 2020
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: March 17, 2025
• Results First Posted: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)