Screening Mammography and Latinas: A Multilevel Intervention
NCT ID: NCT02010008
Last Updated: 2015-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
540 participants
INTERVENTIONAL
2010-05-31
2015-04-30
Brief Summary
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In partnership with the partnering community health center, we have obtained lists of women patients aged 42 to 74 years old who had not had a mammogram in the last two years and resided within defined radii of the four clinics. Baseline and one year follow-up surveys will be obtained by in person home interview. Participants are randomized within clinic to intervention or comparison group. The intervention consist of two motivational interviewing sessions, one in person in the home, and one telephone follow-up. The study hypothesis is that a higher proportion of participants in the motivational interviewing arm will obtain a screening mammogram within the study period than those in the comparison arm.
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Detailed Description
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The recruitment goal of the Fortaleza Latina study is approximately 500 Latina women aged 40-74 who have had a clinic visit within the past 5 years, but no recent mammogram, from the four selected Community Health Center clinics. After providing informed consent and completing a baseline assessment, eligible women are randomly assigned to intervention or comparison group, within clinic. The individual-level intervention implements motivational interviewing (MI) in two participant encounters. MI is a direct counseling style, led by a promotora (lay health advisor), that elicits behavior change by helping participants explore and resolve ambivalence.
Of the 2194 women contacted by field interviewers, a total of 710 surveys have been completed; of these, 542 were eligible and have been randomized and enrolled into the Fortaleza Latina study (279 intervention, 263 usual care).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Motivational Interviewing Intervention
Motivational Interviewing (MI) Intervention includes in -person home visit that elicits behavior change by helping participants explore and resolve ambivalence. A telephone follow-up call also uses MI technique.
Motivational Interviewing Intervention
An individual-level intervention that implements a motivational interviewing intervention led by a promotora
Comparison
Usual care
No interventions assigned to this group
Interventions
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Motivational Interviewing Intervention
An individual-level intervention that implements a motivational interviewing intervention led by a promotora
Eligibility Criteria
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Inclusion Criteria
* Have been seen in one of the 4 community clinics in the past 5 years
* have NOT had a mammogram within the past two years
* Residing within 20 miles of one of the participating clinics
Exclusion Criteria
* Medical record verified recent mammogram
40 Years
74 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Shirley AA Beresford, PhD
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Center
Gloria D Coronado, PhD
Role: PRINCIPAL_INVESTIGATOR
Kaiser Permanente
Locations
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Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
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References
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Coronado GD, Jimenez R, Martinez-Gutierrez J, McLerran D, Ornelas I, Patrick D, Gutierrez R, Bishop S, Beresford SA. Multi-level Intervention to increase participation in mammography screening: inverted exclamation markFortaleza Latina! study design. Contemp Clin Trials. 2014 Jul;38(2):350-4. doi: 10.1016/j.cct.2014.06.008. Epub 2014 Jun 18.
Other Identifiers
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IR 7124
Identifier Type: -
Identifier Source: org_study_id
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