Empowering Latinas to Obtain Breast Cancer Screenings

November 16, 2021 updated by: Yamile Molina, University of Illinois at Chicago
The participatory-based project will quantify the 'added benefit' of an empowerment intervention relative to an education intervention for 150 Latinas on the following outcomes: women's adherence to breast cancer screening guidelines; women's psychosocial facilitators (self-efficacy, norms, support, and knowledge); and women's dissemination of breast health messages throughout their social network. The empowerment intervention will train Latinas in how to discuss breast health with their family and friends and volunteer in local breast health promotion programs. Academic, clinician, and community partners will work together throughout intervention development and evaluation.

Study Overview

Status

Completed

Detailed Description

Latinas suffer disproportionately from breast cancer relative to non-Latina Whites (NLWs), including late stage detection. While there have been controversies in breast cancer screening, non-adherence to guideline-concordant screening continues to be a major modifiable determinant of breast cancer outcome disparities. Thus, increasing participation in breast cancer screening among Latinas, especially care that corresponds with clinical and academic guidelines, is a public health priority. Participatory approaches are popular methods to improve screening within this group and have included approaches that 1) deliver education to non-adherent Latinas and 2) train community health advocates (community health workers, breast cancer survivors) to engage in breast health promotion. The second approach (empowerment interventions) concerns training participants to engage in social outreach (e.g., having conversations with family and friends about breast health) and volunteering (e.g., helping in health fairs, engaging in civic campaigns about breast cancer programs). Patient activation and volunteerism literature suggest that empowerment interventions may have 'added value' for participants themselves over delivering education in terms of preventive health psychosocial factors and practices. Relative to education interventions, empowerment interventions may also affect women's networks, as they may be more likely to disseminate evidence-based breast health promotion among their family and friends. To date, little research has compared interventions' effects on individual-level outcomes or used formal social network analysis to examine network effects. The proposed work adds to the literature through empirically comparing two approaches (education versus empowerment) on three sets of outcomes: 1) women's own screening, 2) women's own self-efficacy, norms, support, knowledge; and 3) women's networks (measured by egocentric analysis). I will lead this work and will benefit from the collective expertise and resources of my mentors (Drs. Ferrans, Mermelstein, Geller) and collaborators (Dr. Schneider, The Resurrection Project, Metropolitan Chicago Breast Cancer Task Force, Sinai Urban Health Institute, University of Illinois Cancer Center). Aim 1 intervention development will be accomplished through continuous stakeholder engagement and specifically through meetings and focus groups with a bilingual, bicultural community advisory engagement board (CEAB), UICC radiologists and target participants (non-adherent Latinas). We have already begun this process and are obtaining formative data. After we develop intervention materials, a pilot trial will be conducted with an area-level treatment control group design in Chicago. Participants will be 150 Latinas with no history of health volunteerism, residence in one of two targeted areas, and non-adherence to US Preventive Services Task Force screening guidelines. Aim 1 intervention evaluation will involve an analysis to compare differences in receipt of a medical record-confirmed screening within six months of participating in the study. Aim 2 will be an analysis to compare interventions' effects on self-efficacy, norms, support, knowledge across three time points - pre-intervention, immediately post-intervention, and six months post-intervention. Aim 3 will be a social network analysis, specifically egocentric, to compare interventions' effects on breast health, network size, and network density as well as will number of peers referred to the study.

Study Type

Interventional

Enrollment (Actual)

145

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
      • Chicago, Illinois, United States, 60608
        • The Resurrection Project
      • Chicago, Illinois, United States, 60617
        • Juan Diego Centro Comunitario

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

52 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age 52-75 years old;
  • Identification as Latina/Hispanic/Chicana female;
  • Residence in Pilsen, Little Village, East Side or South Chicago;
  • No history of health volunteerism;
  • No history of breast cancer; and
  • Lack of a mammogram within the last two years

Exclusion Criteria:

  • Not meeting all inclusion criteria;
  • Women will be excluded if they participated in formative focus groups

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Empowerment
Behavior: Empowerment
Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks
Experimental: Education
Behavior: Education
Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Have Obtained Breast Cancer Screening
Time Frame: 6 months
Receipt of mammogram based on medical records and self report within 6 months of baseline survey (Yes or No)
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Psychosocial Facilitators of Screening Survey Measures
Time Frame: Baseline and 6 months

Total scores/ranges are used. No subscales used. Knowledge - 5 items (Williams et al., 2011). Range for the change scores (baseline to 6-months) is -5 to 5. Higher scores represent a better outcome.

Cultural beliefs - Ferrans cultural beliefs scale (Ferrans et al., 2007). Range for the change scores (baseline to 6-months) is -17 to 17. Higher scores represent a worse outcome.

Breast cancer-specific self-efficacy - Mammography-Specific Self-Efficacy Scale (Champion, Skinner, & Menon, 2005). Range for the change scores (baseline to 6-months) is -26 to 26. Higher scores represent a better outcome.

Positive breast cancer screening norms - 6 items ( Molina et al., 2015). Range for the change scores (baseline to 6-months) is -12 to 12. Higher scores represent a better outcome.

Breast cancer supportive social network size questions comprised an 8-item version of Berkman-Syme index. Range for the change scores (baseline to 6-months) is -25 to 25. Higher scores represent a better outcome.

Baseline and 6 months
Number of Individuals to Whom Participants Exchanged Information About Breast Cancer Screening.
Time Frame: 6 months
This was an open-ended questionnaire, based on the Burt Social Network Instrument. Higher numbers represent better outcomes.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yamile Molina, PhD, University of Illinois at Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

July 24, 2019

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

November 11, 2016

First Submitted That Met QC Criteria

November 11, 2016

First Posted (Estimate)

November 16, 2016

Study Record Updates

Last Update Posted (Actual)

November 18, 2021

Last Update Submitted That Met QC Criteria

November 16, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2015-1246
  • K01CA193918 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After major study findings have been accepted for publication, Dr. Molina will develop an anonymized data set (i.e., no personally identifiable information) available to qualified scientists upon request. Data will only be made available to scientists who complete a data-sharing agreement that indicates: 1) commitment to using the data only for research purposes and not to identify any individual participant; 2) commitment to securing data using appropriate computer technology; and 3) commitment to destroying or returning the data after analyses are completed.

IPD Sharing Time Frame

Data will become available 6 months after publication of the primary outcome papers.

IPD Sharing Access Criteria

The study protocol will be shared upon reasonable request by interested researchers. IRB approval will be required before data are released.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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