Breast Cancer Screening for Underserved Women: Comparing Outcomes and Lowering Recall Rates With 3D- vs. 2D-mammography
- Conditions
- Breast Cancer Screening
- Interventions
- Other: Routine Screening Mammogram (3D + 2D)Other: Routine Screening Mammogram (2D)Other: No Screening Mammogram
- Registration Number
- NCT03979729
- Lead Sponsor
- New Mexico Cancer Care Alliance
- 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).
- Detailed Description
This project will have both a prospective and retrospective component.
Retrospective component:
Primary Objective: To compare recall rates using 3D + 2D- vs. 2D mammogram in New Mexico women undergoing screening mammograms between 2013 and 2016. Data abstraction from the PENRAD database will be completed by staff in the Department of Radiology. Data abstraction for the chart review of the subgroup of State-funded patients will be conducted with HIPAA-compliant practices from the University of New Mexico Hospital (UNMH) electronic medical record. Data analysis will be performed by study investigators.
Prospective component:
Secondary Objective 1: To evaluate knowledge, attitudes, perceived barriers, intentions, and decisional influences (conflict, regret, satisfaction), and other psychosocial/cultural factors influencing breast cancer screening (including concerns over recall vs. radiation exposure) among medically underserved patients and to assess what impact 3D + 2D-mammography (with a potentially lower recall rate but higher radiation exposure) might have on those perceptions. Patients in Groups A and B will undergo 1:1 interviews. Patients in Group C will participate in a one-time focus group (6-8 women per group).
Secondary Objective 2: To determine primary care providers' knowledge, attitudes, beliefs, and preferences regarding 3D + 2D vs. 2D- mammography. Providers will undergo interviews.
Secondary Objective 3A: To evaluate breast cancer detection rate and biopsy positive predictive value in New Mexico women undergoing screening mammogram using 3D + 2D- vs. 2D- mammogram using PENRAD data collected from the group as a whole. This objective will be met via database query alone. No individual mammographic images will be evaluated.
Secondary Objective 3B: To 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 using retrospective chart review. Demographic variables will include age, self-reported ethnicity, city of residence, and health insurance type. This objective will be met via database query alone. No individual mammographic images will be evaluated.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 75
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 3D + 2D-Mammogram Recipients (Patient Group A) Routine Screening Mammogram (3D + 2D) Women presenting for mammographic screening who selected 3D + 2D- mammogram. These women will undergo in-person or telephone interviews. 2D-Mammogram Recipients (Patient Group B) Routine Screening Mammogram (2D) Women presenting for mammographic screening who selected 2D- mammogram alone (declined 3D + 2D- mammogram). These women will undergo in-person or telephone interviews. Women Who Have Never Received a Mammogram (Patient Group C) No Screening Mammogram Women who have never undergone recommended mammographic screening. These women will participate in a onetime facilitated focus group.
- Primary Outcome Measures
Name Time Method Recall rates using 3D + 2D- vs. 2D-mammogram in New Mexico women undergoing screening mammograms (Retrospective analysis) 5 years 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.
- Secondary Outcome Measures
Name Time Method What are primary care providers' knowledge, attitudes, beliefs, and preferences regarding 3D + 2D- vs. 2D-mammography, identified through interviews and questionnaires 5 years Use interviews to create qualitative (descriptive) assessments of care providers' knowledge, attitudes, beliefs, and preferences regarding 3D + 2D- vs. 2D-mammography.
Breast cancer detection rate for 3D + 2D- vs. 2D-mammograms 5 years Evaluate breast cancer detection rate (per 100 patients, percentage) in New Mexico women undergoing screening mammograms using 3D + 2D- vs. 2D-mammogram using PENRAD (mammography tracking software) data collected from the group as a whole.
What psychosocial and cultural factors influence breast cancer screening among medically underserved patients, identified through interviews and questionnaires 5 years Use interviews to create qualitative (descriptive) assessments of the knowledge, attitudes, perceived barriers, intentions, and decisional influences (conflict, regret, satisfaction), and other psychosocial/cultural factors influencing breast cancer screening (including concerns over recall vs. radiation exposure) among medically underserved patients enrolled in or eligible for the Department of Health / State of New Mexico Breast and Cervical Cancer Screening Program or Medicaid and to assess what impact 3D + 2D-mammography (with a potentially lower recall rate but higher radiation exposure) might have on those perceptions.
Breast cancer biopsy positive predictive value for 3D + 2D- vs. 2D-mammograms 5 years Evaluate breast cancer biopsy positive predictive value (per 1000 patients) in New Mexico women undergoing screening mammograms using 3D + 2D- vs. 2D-mammogram using PENRAD (mammography tracking software) data collected from the group as a whole.
Breast cancer detection rate in women undergoing 3-D mammography 5 years Evaluate breast cancer detection rate (per 100 patients) of New Mexico women undergoing screening and offered 3-D mammography based on eligibility requirements for NM House Bill 2, using retrospective chart review.
Positive predictive value of women undergoing 3-D mammography 5 years Evaluate positive predictive value (per 1000 patients) in New Mexico women undergoing screening and offered 3-D mammography based on eligibility requirements for NM House Bill 2, using retrospective chart review.
Screening outcome of women undergoing 3-D mammography 5 years Evaluate screening outcome in New Mexico women undergoing screening and offered 3-D mammography based on eligibility requirements for NM House Bill 2, using retrospective chart review.
Compliance with recall recommendations of women undergoing 3-D mammography 5 years Evaluate compliance with recall recommendations in New Mexico women undergoing screening and offered 3-D mammography based on eligibility requirements for NM House Bill 2, using retrospective chart review.
Trial Locations
- Locations (1)
University of New Mexico Comprehensive Cancer Center
🇺🇸Albuquerque, New Mexico, United States