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| ID | Type | Description | Link |
|---|---|---|---|
| K01CA193918 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| The Resurrection Project | OTHER |
| Juan Diego Centro Comunitario | OTHER |
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empowerment | Experimental | Behavior: Empowerment |
|
| Education | Experimental | Behavior: Education |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empowerment | Behavioral | Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yamile Molina, PhD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Resurrection Project | Chicago | Illinois | 60608 | United States | ||
| University of Illinois at Chicago |
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.
Data will become available 6 months after publication of the primary outcome papers.
The study protocol will be shared upon reasonable request by interested researchers. IRB approval will be required before data are released.
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| ID | Title | Description |
|---|---|---|
| FG000 | Empowerment | Behavior: Empowerment Empowerment: Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks |
| FG001 | Education | Behavior: Education Education: Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Empowerment | Behavior: Empowerment Empowerment: Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks |
| BG001 | Education |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Complete case analysis used - only participants who were retained until 6 month follow-up. | Posted | Count of Participants | Participants | 6 months |
|
Data were collected for up to 6 months per participant.
We used standard definitions of adverse and serious adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Empowerment | Behavior: Empowerment Empowerment: Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks |
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There are several limitations to this study, including a small sample, use of non-probability based sampling strategies, and non-randomization.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yamile Molina | University of Illinois at Chicago | 312-355-2679 | ymolin2@uic.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 3, 2020 | Apr 25, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 7, 2017 | Apr 25, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001941 | Breast Diseases |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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| Education | Behavioral | Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks |
|
| Baseline and 6 months |
| 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 |
| Chicago |
| Illinois |
| 60612 |
| United States |
| Juan Diego Centro Comunitario | Chicago | Illinois | 60617 | United States |
Behavior: Education
Education: Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Insurance | Count of Participants | Participants |
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| Mammogram 4+ years ago | Count of Participants | Participants |
|
| Mammography intention within next year | Count of Participants | Participants |
|
|
|
|
| Other Pre-specified | 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. | This is a complete case analysis for outcome data, with all available data being used for participants who completed the 6-month follow-up. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 months |
|
|
|
|
| Other Pre-specified | 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. | Complete case analysis used, wherein we focus on participants who completed the 6-month follow-up surveys. | Posted | Mean | Standard Deviation | family/friends engaged | 6 months |
|
|
|
|
| 0 |
| 76 |
| 0 |
| 76 |
| 0 |
| 76 |
| EG001 | Education | Behavior: Education Education: Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks | 3 | 69 | 0 | 69 | 0 | 69 |
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| Self-Efficacy |
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| Social Norms |
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| Supportive Network size |
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| Superiority |