Empowering Latinas to Obtain Guideline Concordant Screenings

Breast Cancer Screening Clinical Trial

Official title:

Empowering Latinas to Obtain Guideline Concordant Screenings

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05841355
• Other study ID #: 2022-0531
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2023
• Est. completion date: August 31, 2027

Study information

• Verified date: June 2023
• Source: University of Illinois at Chicago
• Contact: Yamile Molina, PhD
• Phone: 312-355-2679
• Email: ymolin2[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Screening

Intervention

Other:
• Educate
Education sessions
• Empower
Empowerment sessions

Locations

Country	Name	City	State
United States	Mile Square Health Center	Chicago	Illinois
United States	University of Illinois Health	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Compare the number of participants in the non-adherent Latina empowerment arm that obtain guideline-concordant initial and repeat BC screening with the the number of non-adherent Latinas in the education arm	4 years
Primary	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	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	4 years
Primary	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	Compare the number of non-adherent Latinas greater BC knowledge and stronger motivation to be a role model and medicate greater BC screening rates in the empowerment arm than the non-adherent Latinas in the education arm	4 years
Primary	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	Compare the number of non-adherent Latinas greater capacity to promote BC and medicate greater BC screening rates among network members in the empowerment arm than the non-adherent Latinas in the education arm	4 years