- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02964234
Empowering Latinas to Obtain Breast Cancer Screenings
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- University of Illinois at Chicago
-
Chicago, Illinois, United States, 60608
- The Resurrection Project
-
Chicago, Illinois, United States, 60617
- Juan Diego Centro Comunitario
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Empowerment
Behavior: Empowerment
|
Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks
|
Experimental: Education
Behavior: Education
|
Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Baseline and 6 months
|
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.
|
6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Yamile Molina, PhD, University of Illinois at Chicago
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-1246
- K01CA193918 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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