Screening Mammography and Latinas: A Multilevel Intervention
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|ClinicalTrials.gov Identifier: NCT02010008|
Recruitment Status : Completed
First Posted : December 12, 2013
Last Update Posted : July 2, 2015
¡Fortaleza Latina! is a multi-level randomized trial to increase participation in mammography screening among Latinas who seek care at a community health center in Western Washington.
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Behavioral: Motivational Interviewing Intervention||Not Applicable|
Breast cancer is the most common cancer among Hispanic women in the United States (US) and five-year survival from breast cancer is lower in Hispanic than in non-Hispanic White women. This reduced survival has a number of potential causes, but differential screening rates may be a partial explanation, since Hispanic women have lower breast cancer screening rates than non-Hispanic White women. The overall purpose of the study is to develop and evaluate a culturally-appropriate intervention aimed at increasing screening mammography rates in a clinic-based sample of predominantly Mexican American women in Western Washington.
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||540 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Understanding and Preventing Breast Cancer Disparities in Latinas: Screening Mammography and Latinas: A Multilevel Intervention|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
Experimental: 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.
Behavioral: Motivational Interviewing Intervention
An individual-level intervention that implements a motivational interviewing intervention led by a promotora
No Intervention: Comparison
- Mammography Screening [ Time Frame: One year post baseline ]Through medical record review at one year follow up, women will be classified as receiving or not receiving mammography screening since baseline assessment
- Self-report of mammography screening [ Time Frame: One year post baseline ]At the one year follow-up women are asked have they ever had a mammogram, and then when was the most recent mammogram. responses are used in conjunction with date of baseline survey.
- Relative cost [ Time Frame: one year ]Cost of intervention is set against potential savings in treatment costs associated with late diagnosis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02010008
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109-1024|
|Principal Investigator:||Shirley AA Beresford, PhD||Fred Hutchinson Cancer Research Center|
|Principal Investigator:||Gloria D Coronado, PhD||Kaiser Permanente|