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NCT03979729

Breast Cancer Screening for Underserved Women: Comparing Outcomes and Lowering Recall Rates With 3D- vs. 2D-mammography

Sponsor: New Mexico Cancer Research Alliance

View on ClinicalTrials.gov

Summary

Three-dimensional (3D) + two-dimensional (2D)- mammography may have particular value for minority, rural, and underserved women in New Mexico by decreasing recall rates and improving diagnostic sensitivity, thus alleviating some of the unique burdens associated with breast cancer screening in the multi-ethnic and underserved New Mexico patient population. Primary objective: To compare recall rates using 3D + 2D- vs. 2D- mammogram in New Mexico women undergoing screening mammogram between 2013 and 2016. Secondary objectives: Evaluate knowledge, attitudes, perceived barriers, intentions, decisional influences, and other psychosocial/cultural factors influencing breast cancer screening among medically underserved patients and assess what impact 3D + 2D-mammography might have on those perceptions; Determine primary care providers' knowledge, attitudes, beliefs, and preferences regarding 3D + 2D- vs. 2D- mammography; evaluate breast cancer detection rate and biopsy positive predictive value for screening mammograms using 3D + 2D- vs. 2D using PENRAD data; evaluate screening outcome, compliance with recall recommendations, breast cancer detection rate, positive predictive value, and demographics of interest in New Mexico women undergoing screening and offered 3-D mammography (retrospective chart review).

Official title: Breast Cancer Screening Among Medically Underserved Women in New Mexico: Comparing Outcomes and LOwering Recall Rates With Digital Breast Tomosynthesis (3D Mammography) VErsus Full-field Digital (2D) Mammography. The LOVE New Mexico Study

Key Details

Gender

FEMALE

Age Range

40 Years - Any

Study Type

OBSERVATIONAL

Enrollment

Start Date

2016-09-22

Completion Date

2021-06-03

Last Updated

2026-10-22

Healthy Volunteers

Yes

Conditions

Breast Cancer Screening

Interventions

OTHER

Routine Screening Mammogram (3D + 2D)

Subjects that have undergone a routine screening mammogram (3D + 2D) will be interviewed by a member of the research team who will ask a few questions to better understand how the subject made this decision and what things may have influenced her decision between different types of mammograms.

OTHER

Routine Screening Mammogram (2D)

Subjects that have undergone a routine screening mammogram (2D) will be interviewed by a member of the research team who will ask a few questions to better understand how the subject made this decision and what things may have influenced her decision between different types of mammograms.

OTHER

No Screening Mammogram

Subjects will participate in a one-time facilitated focus group.

Inclusion Criteria for Retrospective Component (Primary Objective): \* Screening mammographic examinations performed in women over age 40 undergoing 3D +2D- or 2D-screening mammogram through the University of New Mexico's Department of Radiology at the University of New Mexico Hospital (UNMH) and Sandoval Regional Medical Center (SRMC) between 2013 and 2016 Inclusion Criteria for Prospective Component (Secondary Objective #1) (Patient Groups A and B) * Women over age 40 undergoing screening mammogram through the University of New Mexico's Department of Radiology as recommended and ordered by their primary care provider * Must have the ability to understand a consent form * Enrolled or eligible for the Department of Health / State of New Mexico Breast and Cervical Cancer Screening Program or Medicaid * Must have been offered a choice of either 3D + 2D-mammography or 2D-mammography as screening for breast cancer and underwent the selected screening prior to consent * Pregnant women may participate in this study Exclusion Criteria for Prospective Component (Secondary Objective #1) (Patient Groups A and B): * Cognitively impaired adult women are excluded from participation * Adult women not able to consent for themselves are excluded from participation * Prisoners may not participate in this study Inclusion Criteria for Prospective Component (Secondary Objective #1) (Patient Group C): * Women over age 40 recommended for mammographic screening for breast cancer by a primary care provider, but have never completed a screening mammogram * Must have the ability to understand a consent form * Enrolled or eligible for the Department of Health / State of New Mexico Breast and Cervical Cancer Screening Program or for Medicaid * Pregnant women may participate in this study Exclusion Criteria for Prospective Component (Secondary Objective #1) (Patient Group C): * Cognitively impaired adult women are excluded from participation * Adult women not able to consent for themselves are excluded from participation * Prisoners may not participate in this study Inclusion Criteria for Providers (Secondary Objective #2): \* Primary care providers (physicians, physicians assistants, and advanced nurse practitioners) working in clinics providing primary care for underserved patient populations in New Mexico, including primary care providers at a RIOSNET-affiliated and UNM-affiliated clinics Exclusion Criteria for Providers (Secondary Objective #2): \* Any primary care provider who does not order screening mammography for eligible participants or is under Medicaid violation review

Locations (1)

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, United States

Clinical Research Directory

Breast Cancer Screening for Underserved Women: Comparing Outcomes and Lowering Recall Rates With 3D- vs. 2D-mammography

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)