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Empowering Latinas to Obtain Breast Cancer Screenings

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ClinicalTrials.gov Identifier: NCT02964234
Recruitment Status : Recruiting
First Posted : November 16, 2016
Last Update Posted : May 3, 2018
Sponsor:
Collaborators:
The Resurrection Project
Juan Diego Centro Comunitario
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Yamile Molina, University of Illinois at Chicago

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.

Condition or disease Intervention/treatment Phase
Breastcancer Breast Diseases Behavioral: Empowerment Behavioral: Education Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Empowering Latinas to Obtain Breast Cancer Screenings
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Empowerment
Behavior: Empowerment
Behavioral: Empowerment
Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks

Experimental: Education
Behavior: Education
Behavioral: Education
Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks




Primary Outcome Measures :
  1. Number of participants who have obtained breast cancer screening [ Time Frame: 6 months ]
    Electronic Medical Records (Yes/No); Improvement: Yes/receipt of mammogram


Other Outcome Measures:
  1. Number of participants who report improvements in psychosocial facilitators of screening survey measures [ Time Frame: 6 months ]
    Survey measures with 5-point likert scales; Improvement: 25% change in survey outcomes

  2. Number of participants who report improvements in social network surveys [ Time Frame: 6 months ]
    Survey measures with 0-1.0 scales; Improvement: 25% change in survey outcomes



Information from the National Library of Medicine

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Ages Eligible for Study:   52 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02964234


Contacts
Contact: Yamile Molina, PhD 3123552679 ymolin2@uic.edu

Locations
United States, Illinois
The Resurrection Project Recruiting
Chicago, Illinois, United States, 60608
Contact: Yamile Molina, PhD    312-355-2679    ymolin2@Uic.edu   
University of Illinois at Chicago Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Yamile Molina, PhD    312-355-2679    ymolin2@uic.edu   
Juan Diego Centro Comunitario Recruiting
Chicago, Illinois, United States, 60617
Contact: Yamile Molina, PhD    312-355-2679      
Sponsors and Collaborators
University of Illinois at Chicago
The Resurrection Project
Juan Diego Centro Comunitario
National Cancer Institute (NCI)
Investigators
Principal Investigator: Yamile Molina, PhD University of Illinois at Chicago

Responsible Party: Yamile Molina, Assistant Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02964234     History of Changes
Other Study ID Numbers: K01CA193918 ( U.S. NIH Grant/Contract )
First Posted: November 16, 2016    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Time Frame: Data will become available 6 months after publication of the primary outcome papers.
Access Criteria: The study protocol will be shared upon reasonable request by interested researchers. IRB approval will be required before data are released.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yamile Molina, University of Illinois at Chicago:
Mammography Screening
Latinas
Breast cancer disparities

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Neoplasms
Skin Diseases