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Trial Title:
Empowering Latinas to Obtain Guideline Concordant Screenings
NCT ID:
NCT05841355
Condition:
Breast Cancer Screening
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
Educate
Description:
Education sessions
Arm group label:
Educate (Education + Navigation) Sessions
Intervention type:
Other
Intervention name:
Empower
Description:
Empowerment sessions
Arm group label:
Empower (Empowerment + Navigation) Sessions
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.
Criteria for 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.
Gender:
Female
Gender based:
Yes
Minimum age:
50 Years
Maximum age:
74 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Mile Square Health Center
Address:
City:
Chicago
Zip:
60612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jocelyn Perez
Phone:
312-996-6337
Email:
jocelynp@uic.edu
Facility:
Name:
University of Illinois Health
Address:
City:
Chicago
Zip:
60612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jocelyn Perez
Phone:
312-996-6337
Email:
jocelynp@uic.edu
Start date:
March 14, 2023
Completion date:
August 31, 2027
Lead sponsor:
Agency:
University of Illinois at Chicago
Agency class:
Other
Source:
University of Illinois at Chicago
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05841355
