Clinical trial NCT05841355: Empowering Latinas to Obtain Guideline Concordant Screenings
Official title: Empowering Latinas to Obtain Guideline Concordant Screenings
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Screening
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 400
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Compare intervention effects on BC screening among 400 non-adherent Latinas in a 1:1 empower/educate ratio (n=200 per group)
Primary purpose: SCREENING

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 Brease Cancer (BC) screening.

Detailed description: To further test the added benefits of the empower approach relative to traditional educate approaches. Past community research among Latinas 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 Latinas 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 among Latinas 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 Latinas may "boost" intervention effects throughout their networks.

Aim 1: Among 400 non-adherent Latinas, 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., 50-74 year-olds should obtain mammograms every 2 years.

Aim 2: Among 200 network members of non-adherent Latinas, 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.

Eligibility criteria: Inclusion Criteria:

Aim 1. (1) female biological sex; (2) identification as Latinas; (3) non-adherence to USPSTF guidelines (52-74 years old, no mammogram in past 2 years, no previous BC diagnosis); (4) no previous history of health volunteerism; and (5) not a network member enrolled in Aim 2.

Aim 2. (1) female biological sex; (2) eligibility to obtain BC screenings by USPSTF guidelines (i.e., 50-74 years old, no personal BC history); (3) referral from non-adherent Latinas; (4) no previous history of health volunteerism; and (5) no participation in the RCT (not an Aim 1 participant, no Session #3 attendance).

Exclusion Criteria:

Aim 1: (1) Not meeting at least one of the aforementioned Aim 1 inclusion criteria.

Aim 2: (1) Not meeting at least one of the aforementioned Aim 1 inclusion criteria.

Primary outcomes:
measure: Non-adherent Latinas in the empowerment arm are more likely to obtain initial and repeat BC screening than non-adherent Latinas in the education arem
timeFrame: 4 years
measure: Network members in the empowerment arm will be more likely to obtain guideline-concordant initial and repeat BC screening than network members in the educate arm
timeFrame: 4 years
measure: Non-adherent Latinas greater BC knowledge and stronger motivation to be a role model will mediate the greater BC screening rates among non-adherent Latinas in the empower arm relative to the educate arm
timeFrame: 4 years
measure: Non-adherent Latinas' greater capacity to promote BC will mediate the greater BC screening rates among network members in the empower arm relative to the educate arm
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Mile Square Health Center
state: Illinois
city: Chicago
country: United States
facility: University of Illinois Health
state: Illinois
Study officials:
References: