MADRE (Mammograms Available Due to Research and Education)

Not Applicable

Recruiting

• Conditions: Breast Cancer Screening

• Registration Number: NCT05841355
• Lead Sponsor: University of Illinois at Chicago

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.

Detailed Description

To further test the added benefits of the empower approach relative to traditional educate approaches. Past community research has primarily focused on one-time BC screening among intervention participants. 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 BC screening. The investigator will estimate the widespread effects of interventions by prospectively collecting data from network members not involved in the RCT. The investigator will also explore "active ingredients" that underlie intervention effects, including psychosocial, IS and network mechanisms. Overall, the investigator will demonstrate whether and how non-adherent individuals may "boost" intervention effects throughout their networks.

The investigator's goal is to further test the added benefits of the empower approach relative to traditional educate approaches. Past community research has primarily focused on one-time BC screening among intervention participants. The investigator's novel 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 BC screening. The investigator will estimate the widespread effects of interventions by prospectively collecting data from network members not involved in the RCT. The investigator will also explore "active ingredients" that underlie intervention effects, including psychosocial, IS and network mechanisms. Overall, the investigator will demonstrate whether and how non-adherent individuals may "boost" intervention effects throughout their networks.

Aim 1: Among 400 non-adherent individuals, the investigator will compare intervention effects on BC screening, using an individual RCT in a federally qualified health center (FQHC). The investigator will use the US Preventative Services Task Force (USPSTF) guidelines - i.e., 40-74 year-olds should obtain mammograms every 2 years.

Aim 2: Among 200 network members, the investigator will compare intervention effects on BC screening, based on the USPSTF guidelines.

Aim 3: The investigator will explore mechanisms of change underlying intervention effects on BC screening using IS measures, descriptive SNA, and structural equation models. If study arms are comparable, the investigator will examine which mechanisms may predict multilevel intervention effects across approaches.

Study Timeline

• Study Start: 2023-03-14
• Study First Submitted: 2023-04-23
• Study First Submitted QC: 2023-04-23
• Study First Posted: 2023-05-03
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-07
• Last Update Posted: 2025-07-10
• Primary Completion: 2027-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

• 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.

Exclusion Criteria

* Not meeting at least one of the aforementioned Aim 1 inclusion criteria.

Aim 2.

Inclusion Criteria:

• 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).

Exclusion Criteria

• Not meeting at least one of the aforementioned Aim 1 inclusion criteria.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Breast Cancer (BC) Screening (Aim 1)	1-4 years	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
Breast Cancer Screening (Aim 2)	1-4 years	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

Trial Locations

Locations (2)

Mile Square Health Center; 🇺🇸 Chicago, Illinois, United States

University of Illinois Health; 🇺🇸 Chicago, Illinois, United States