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
  Purpose

¡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 Intervention
Breast Cancer
Behavioral: Motivational Interviewing Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Understanding and Preventing Breast Cancer Disparities in Latinas: Screening Mammography and Latinas: A Multilevel Intervention

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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


Enrollment: 540
Study Start Date: May 2010
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Usual care

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).

  Eligibility

Ages Eligible for Study:   40 Years to 74 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02010008

Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Shirley AA Beresford, PhD Fred Hutchinson Cancer Research Center
Principal Investigator: Gloria D Coronado, PhD Kaiser Permanente
  More Information

No publications provided by Fred Hutchinson Cancer Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT02010008     History of Changes
Other Study ID Numbers: IR 7124, P50CA148143
Study First Received: December 9, 2013
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Fred Hutchinson Cancer Research Center:
breast cancer
cancer disparities
Latino women
Hispanic women
mammography
multi-level intervention

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 01, 2014