Empowering Latinas to Obtain Breast Cancer Screenings

Breast Diseases Clinical Trial

Official title:

Empowering Latinas to Obtain Breast Cancer Screenings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02964234
• Other study ID #: 2015-1246
• Secondary ID: K01CA193918
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: August 31, 2021

Study information

• Verified date: November 2021
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: August 31, 2021
• Est. primary completion date: July 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 52 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Diseases
• Breast Neoplasms
• Breastcancer

Intervention

Behavioral:
• Empowerment
Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks
• Education
Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks

Locations

Country	Name	City	State
United States	Juan Diego Centro Comunitario	Chicago	Illinois
United States	The Resurrection Project	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Juan Diego Centro Comunitario, National Cancer Institute (NCI), The Resurrection Project

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Psychosocial Facilitators of Screening Survey Measures	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
Other	Number of Individuals to Whom Participants Exchanged Information About Breast Cancer Screening.	This was an open-ended questionnaire, based on the Burt Social Network Instrument. Higher numbers represent better outcomes.	6 months
Primary	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)	6 months