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

NCT03979729 | Completed

• 1 other identifier: INST UNM 1525
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Breast Cancer Screening

Outcome Measures

Primary Outcomes (1)

• Recall rates using 3D + 2D- vs. 2D-mammogram in New Mexico women undergoing screening mammograms (Retrospective analysis)

  Compare the recall rates of New Mexico (NM) women over age 40 who underwent 3D + 2D screening mammograms vs. recall rates for women who underwent 2D- screening mammograms between 2013 and 2016 through the University of New Mexico's Department of Radiology at the University of New Mexico Hospital (UNMH) and Sandoval Regional Medical Center (SRMC). The "recall rate" is defined as the percentage (number of patients recalled per 100 patients who had mammograms) of New Mexico women undergoing screening mammogram between 2013 and 2016 recalled for additional diagnostic imaging when screening mammogram was performed with digital breast tomosynthesis (3D + 2D-mammography) or 2- dimensional full-field digital mammography alone. The University of New Mexico's Department of Radiology PENRAD database will queried anonymously for this data.

  5 years

Secondary Outcomes (8)

• What psychosocial and cultural factors influence breast cancer screening among medically underserved patients, identified through interviews and questionnaires

  5 years

• What are primary care providers' knowledge, attitudes, beliefs, and preferences regarding 3D + 2D- vs. 2D-mammography, identified through interviews and questionnaires

  5 years

• Breast cancer detection rate for 3D + 2D- vs. 2D-mammograms

  5 years

• Breast cancer biopsy positive predictive value for 3D + 2D- vs. 2D-mammograms

  5 years

• Screening outcome of women undergoing 3-D mammography

  5 years

Study Arms (4)

3D + 2D-Mammogram Recipients (Patient Group A)

Women presenting for mammographic screening who selected 3D + 2D- mammogram. These women will undergo in-person or telephone interviews.

Other: Routine Screening Mammogram (3D + 2D)

2D-Mammogram Recipients (Patient Group B)

Women presenting for mammographic screening who selected 2D- mammogram alone (declined 3D + 2D- mammogram). These women will undergo in-person or telephone interviews.

Other: Routine Screening Mammogram (2D)

Women Who Have Never Received a Mammogram (Patient Group C)

Women who have never undergone recommended mammographic screening. These women will participate in a onetime facilitated focus group.

Other: No Screening Mammogram

Providers

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

Interventions

Routine Screening Mammogram (3D + 2D) OTHER

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.

3D + 2D-Mammogram Recipients (Patient Group A)

Routine Screening Mammogram (2D) OTHER

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.

2D-Mammogram Recipients (Patient Group B)

No Screening Mammogram OTHER

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

Women Who Have Never Received a Mammogram (Patient Group C)

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Retrospective and prospective portions of study (patients): Women over age 40 recommended for mammographic screening for breast cancer by a primary care provider, who are enrolled or eligible for the Department of Health / State of New Mexico Breast and Cervical Cancer Screening Program or Medicaid. Prospective portion (providers): 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.

You may qualify if:

• \* 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
• 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

You may not qualify if:

• 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
• 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
• 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
• \* 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
• \* Any primary care provider who does not order screening mammography for eligible participants or is under Medicaid violation review

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead

Study Sites (1)

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (1)

• Manda-Mapalo MT, Fine SG, Safadi S, Lee JH, Du R, Sussman AL, Mishra S, Selwyn RG, Saline JL, Hine WL, Brown-Glaberman UA. Breast Cancer Screening Among Medically Underserved Women in New Mexico: Potential for Lower Recall Rates with Digital Breast Tomosynthesis. J Womens Health (Larchmt). 2020 Dec;29(12):1596-1601. doi: 10.1089/jwh.2020.8402. Epub 2020 Sep 29.

  PMID: 32991242 DERIVED

Study Officials

• Stephanie Fine, MD

  University of New Mexico Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: June 7, 2019
• Study Start: September 22, 2016
• Primary Completion: May 7, 2020
• Study Completion: June 3, 2021
• Last Updated: October 5, 2022

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)