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Empowering Latinas to Obtain Breast Cancer Screenings

Primary Purpose

Breastcancer, Breast Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Empowerment
Education
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breastcancer focused on measuring Mammography Screening, Latinas, Breast cancer disparities

Eligibility Criteria

52 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • The Resurrection Project
  • University of Illinois at Chicago
  • Juan Diego Centro Comunitario

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Empowerment

Education

Arm Description

Behavior: Empowerment

Behavior: Education

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 11, 2016
Last Updated
November 16, 2021
Sponsor
University of Illinois at Chicago
Collaborators
The Resurrection Project, Juan Diego Centro Comunitario, National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02964234
Brief Title
Empowering Latinas to Obtain Breast Cancer Screenings
Official Title
Empowering Latinas to Obtain Breast Cancer Screenings
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
July 24, 2019 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
The Resurrection Project, Juan Diego Centro Comunitario, National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breastcancer, Breast Diseases
Keywords
Mammography Screening, Latinas, Breast cancer disparities

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Empowerment
Arm Type
Experimental
Arm Description
Behavior: Empowerment
Arm Title
Education
Arm Type
Experimental
Arm Description
Behavior: Education
Intervention Type
Behavioral
Intervention Name(s)
Empowerment
Intervention Description
Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks
Primary Outcome Measure Information:
Title
Number of Participants Who Have Obtained Breast Cancer Screening
Description
Receipt of mammogram based on medical records and self report within 6 months of baseline survey (Yes or No)
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Changes in Psychosocial Facilitators of Screening Survey Measures
Description
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.
Time Frame
Baseline and 6 months
Title
Number of Individuals to Whom Participants Exchanged Information About Breast Cancer Screening.
Description
This was an open-ended questionnaire, based on the Burt Social Network Instrument. Higher numbers represent better outcomes.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
52 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yamile Molina, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Resurrection Project
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Juan Diego Centro Comunitario
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60617
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Empowering Latinas to Obtain Breast Cancer Screenings

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