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Recruiting NCT05841355

MADRE (Mammograms Available Due to Research and Education)

No phase Interventional Breast Cancer Screening

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Educate, Empower.
Who it may be relevant to
Registry conditions: Breast Cancer Screening. Basic parameters: 40 years — 74 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Educate
    Education sessions
  • Other Empower
    Empowerment sessions

Primary outcome measures

  • Breast Cancer (BC) Screening (Aim 1) [Time frame: 1-4 years]
  • Breast Cancer Screening (Aim 2) [Time frame: 1-4 years]

Eligibility criteria

Aim 1

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Screening

Study locations

United States · 2 centers
  • Mile Square Health Center — Chicago
  • University of Illinois Health — Chicago

Publications

  • 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 39719248

Identifiers

NCT: NCT05841355 · 2022-0531

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗