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NCT Number: NCT05841355

MADRE (Mammograms Available Due to Research and Education)

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.

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Key information

Age range

40 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mile Square Health Center, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Educate

Other

Education sessions

Empower

Other

Empowerment sessions

Primary outcomes

  1. Breast Cancer (BC) Screening (Aim 1)

    Time frame: 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

  2. Breast Cancer Screening (Aim 2)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jocelyn Perez

CONTACT

[email protected]

312-996-6337

Yamile Molina, PhD

CONTACT

[email protected]

312-355-2679

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Acronym: MADRE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 3, 2023
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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