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Completed

NCT Number: NCT02964234

Empowering Latinas to Obtain Breast Cancer Screenings

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.

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Key information

Age range

52 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Juan Diego Centro Comunitario, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Empowerment

Behavioral

Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks

Education

Behavioral

Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks

Primary outcomes

  1. 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)

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • Juan Diego Centro Comunitario
  • National Cancer Institute (NCI)
  • The Resurrection Project

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Nov 16, 2016
Registry last updated
Nov 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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