Screening Mammography and Latinas: A Multilevel Intervention

Breast Cancer Clinical Trial

Official title:

Understanding and Preventing Breast Cancer Disparities in Latinas: Screening Mammography and Latinas: A Multilevel Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02010008
• Other study ID #: IR 7124
• Secondary ID: P50CA148143
• Status: Completed
• Phase: N/A
• First received: December 9, 2013
• Last updated: July 1, 2015
• Start date: May 2010
• Est. completion date: April 2015

Study information

• Verified date: July 2015
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 74 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Motivational Interviewing Intervention
An individual-level intervention that implements a motivational interviewing intervention led by a promotora

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relative cost	Cost of intervention is set against potential savings in treatment costs associated with late diagnosis	one year	No
Primary	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	No
Secondary	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.	One year post baseline	No