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Screening Mammography and Latinas: A Multilevel Intervention

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing Intervention
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring breast cancer, cancer disparities, Latino women, Hispanic women, mammography, multi-level intervention

Eligibility Criteria

40 Years - 74 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Fred Hutchinson Cancer Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Motivational Interviewing Intervention

Comparison

Arm Description

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.

Usual care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Self-report of mammography screening
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.

Full Information

First Posted
December 9, 2013
Last Updated
July 1, 2015
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02010008
Brief Title
Screening Mammography and Latinas: A Multilevel Intervention
Official Title
Understanding and Preventing Breast Cancer Disparities in Latinas: Screening Mammography and Latinas: A Multilevel Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, cancer disparities, Latino women, Hispanic women, mammography, multi-level intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
540 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motivational Interviewing Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Comparison
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing Intervention
Intervention Description
An individual-level intervention that implements a motivational interviewing intervention led by a promotora
Primary Outcome Measure Information:
Title
Mammography Screening
Description
Through medical record review at one year follow up, women will be classified as receiving or not receiving mammography screening since baseline assessment
Time Frame
One year post baseline
Secondary Outcome Measure Information:
Title
Self-report of mammography screening
Description
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.
Time Frame
One year post baseline
Other Pre-specified Outcome Measures:
Title
Relative cost
Description
Cost of intervention is set against potential savings in treatment costs associated with late diagnosis
Time Frame
one year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shirley AA Beresford, PhD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gloria D Coronado, PhD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24952281
Citation
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.
Results Reference
derived

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Screening Mammography and Latinas: A Multilevel Intervention

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