NCT02010008

Brief Summary

¡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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
540

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started May 2010

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

July 2, 2015

Status Verified

July 1, 2015

Enrollment Period

4.9 years

First QC Date

December 9, 2013

Last Update Submit

July 1, 2015

Conditions

Breast Cancer

Keywords

breast cancercancer disparitiesLatino womenHispanic womenmammographymulti-level intervention

Outcome Measures

Primary Outcomes (1)

  • Mammography Screening

    Through medical record review at one year follow up, women will be classified as receiving or not receiving mammography screening since baseline assessment

    One year post baseline

Secondary Outcomes (1)

  • Self-report of mammography screening

    One year post baseline

Other Outcomes (1)

  • Relative cost

    one year

Study Arms (2)

Motivational Interviewing Intervention

EXPERIMENTAL

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

Comparison

NO INTERVENTION

Usual care

Interventions

Motivational Interviewing InterventionBEHAVIORAL

An individual-level intervention that implements a motivational interviewing intervention led by a promotora

Motivational Interviewing Intervention

Eligibility Criteria

Age40 Years - 74 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Participants who do not match the Eligibility Criteria listed above
  • Medical record verified recent mammogram

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

Related Publications (1)

  • 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.

    PMID: 24952281DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Shirley AA Beresford, PhD

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

  • Gloria D Coronado, PhD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2013

First Posted

December 12, 2013

Study Start

May 1, 2010

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

July 2, 2015

Record last verified: 2015-07

Locations

US(1)