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Screening Mammography and Latinas: A Multilevel Intervention

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT02010008
First received: December 9, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted

December 9, 2013
December 9, 2013
May 2010
June 2014   (final data collection date for primary outcome measure)
Mammography Screening [ Time Frame: One year post baseline ] [ Designated as safety issue: No ]
Through medical record review at one year follow up, women will be classified as receiving or not receiving mammography screening since baseline assessment
Same as current
No Changes Posted
Self-report of mammography screening [ Time Frame: One year post baseline ] [ Designated as safety issue: No ]
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.
Same as current
Relative cost [ Time Frame: one year ] [ Designated as safety issue: No ]
Cost of intervention is set against potential savings in treatment costs associated with late diagnosis
Same as current
 
Screening Mammography and Latinas: A Multilevel Intervention
Understanding and Preventing Breast Cancer Disparities in Latinas: Screening Mammography and Latinas: A Multilevel Intervention

¡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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Breast Cancer
Behavioral: Motivational Interviewing Intervention
An individual-level intervention that implements a motivational interviewing intervention led by a promotora
  • 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.
    Intervention: Behavioral: Motivational Interviewing Intervention
  • No Intervention: Comparison
    Usual care
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: ¡Fortaleza Latina! study design. Contemp Clin Trials. 2014 Jul;38(2):350-4. doi: 10.1016/j.cct.2014.06.008. Epub 2014 Jun 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
540
May 2015
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hispanic/Latina ethnicity
  • 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:

  • Participants who do not match the Eligibility Criteria listed above
  • Medical record verified recent mammogram
Female
40 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT02010008
IR 7124, P50CA148143
No
Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Principal Investigator: Shirley AA Beresford, PhD Fred Hutchinson Cancer Research Center
Principal Investigator: Gloria D Coronado, PhD Kaiser Permanente
Fred Hutchinson Cancer Research Center
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP