MADRE (Mammograms Available Due to Research and Education)

University of Illinois

Status: Enrolling

Conditions: Breast Cancer Screening

Treatments: Other: Empower; Other: Educate

Study type: Interventional

Funder types: Other

Identifiers

NCT05841355

2022-0531

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 40 to 74 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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600 participants in 2 patient groups

Educate (Education + Navigation) Sessions

Other group

Description:

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

Treatment:

Other: Educate

Empower (Empowerment + Navigation) Sessions

Other group

Description:

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)

Treatment:

Other: Empower