NCT05841355

Brief Summary

The design builds on past studies by integrating social network analysis (SNA) and implementation science (IS) into a longitudinal randomized clinical trial (RCT). The investigator will compare the long-term effects of interventions by examining guideline-concordant initial and repeat Breast Cancer (BC) screening.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Mar 2023Aug 2027

Study Start

First participant enrolled

March 14, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 23, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

July 10, 2025

Status Verified

July 1, 2025

Enrollment Period

4.5 years

First QC Date

April 23, 2023

Last Update Submit

July 7, 2025

Conditions

Breast Cancer Screening

Outcome Measures

Primary Outcomes (2)

  • Breast Cancer (BC) Screening (Aim 1)

    Compare the number of participants in the empowerment arm that obtain guideline-concordant initial and repeat BC screening with the the number of participants in the education arm

    1-4 years

  • Breast Cancer Screening (Aim 2)

    Compare the number of network members in the empowerment arm that obtain guideline-concordant initial and repeat BC screening with the number of non-adherent network members in the education arm

    1-4 years

Study Arms (2)

Educate (Education + Navigation) Sessions

OTHER

Session 1 BC knowledge, BC disparities, USPSTF guidelines, barriers and preferred solutions to BC screening, Community Health Workers (CHW) testimonials, empirical data, individual action plans for BC screening Session 2 \&3 Health knowledge (diet and physical activity guidelines), barriers and preferred solutions to dietary and physical activity change, CHW testimonials, empirical data, individual action plans for diet

Other: Educate

Empower (Empowerment + Navigation) Sessions

OTHER

Session 1 BC knowledge, BC disparities, USPSTF guidelines, barriers and preferred solutions to BC screening CHW testimonials, Empirical data, Individual action plans for BC screening Sessions 2 \& 3 BC screening as leading by example, BC promotion strategies that reflect personal and network members' preferences, opportunities to volunteer/be a part of tight-knit initiatives, partnerships with navigators/CHWs to serve as "bridges" for network members CHW testimonials , resource guides for BC promotion, individual action plans for promoting BC, role playing activities (session 2) Participant testimonials, participant relays empirical data, group discussion and plans for promoting BC (session 3)

Other: Empower

Interventions

EducateOTHER

Education sessions

Educate (Education + Navigation) Sessions
EmpowerOTHER

Empowerment sessions

Empower (Empowerment + Navigation) Sessions

Eligibility Criteria

Age40 Years - 74 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female biological sex
  • identification as Latinas
  • non-adherence to USPSTF guidelines (42-74 years old, no mammogram in past 2 years, no previous BC diagnosis)
  • no previous history of health volunteerism
  • not a network member enrolled in Aim 2.

You may not qualify if:

  • Aim 2.
  • female biological sex
  • eligibility to obtain BC screenings by USPSTF guidelines (i.e., 40-74 years old, no personal BC history)
  • referral from Aim 1 participants
  • no previous history of health volunteerism
  • no participation in the RCT (not an Aim 1 participant, no Session #3 attendance).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mile Square Health Center

Chicago, Illinois, 60612, United States

RECRUITING

University of Illinois Health

Chicago, Illinois, 60612, United States

RECRUITING

Related Publications (1)

  • McClellan SP, De La Paz E, Arroyo J, Montoya S, Perez J, Wright E, Moreno E, Padilla M, Kroenke CH, Rauscher GH, Neuschler E, Ganschow P, Stackhouse N, Atkins M, Dziak JJ, Neal JW, Lucio A, Molina Y. The "Mammograms Available Due to Resources and Education" (MADRE) Study: Rationale and Design. Contemp Clin Trials. 2025 Feb;149:107786. doi: 10.1016/j.cct.2024.107786. Epub 2024 Dec 22.

    PMID: 39719248DERIVED

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Central Study Contacts

Yamile Molina, PhD

CONTACT

312-355-2679ymolin2@uic.edu

Jocelyn Perez

CONTACT

312-996-6337jocelynp@uic.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Compare intervention effects on BC screening among 400 non-adherent individuals in a 1:1 empower/educate ratio (n=200 per group)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 23, 2023

First Posted

May 3, 2023

Study Start

March 14, 2023

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

July 10, 2025

Record last verified: 2025-07

Locations

US(2)