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

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

Sponsors

Lead Sponsor: New Mexico Cancer Care Alliance

Source 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.

Overall Status Active, not recruiting
Start Date 2016-09-22
Completion Date 2024-12-31
Primary Completion Date 2023-12-31
Study Type Observational
Primary Outcome
Measure Time Frame
Recall rates using 3D + 2D- vs. 2D-mammogram in New Mexico women undergoing screening mammograms (Retrospective analysis) 5 years
Secondary Outcome
Measure Time Frame
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
Compliance with recall recommendations of women undergoing 3-D mammography 5 years
Breast cancer detection rate in women undergoing 3-D mammography 5 years
Positive predictive value of women undergoing 3-D mammography 5 years
Enrollment 75
Condition
Intervention

Intervention Type: Other

Intervention Name: Routine Screening Mammogram (3D + 2D)

Description: 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.

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

Intervention Type: Other

Intervention Name: Routine Screening Mammogram (2D)

Description: 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.

Arm Group Label: 2D-Mammogram Recipients (Patient Group B)

Intervention Type: Other

Intervention Name: No Screening Mammogram

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

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

Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

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

Gender:

Female

Minimum Age:

40 Years

Maximum Age:

N/A

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Stephanie Fine, MD Principal Investigator University of New Mexico Comprehensive Cancer Center
Overall Contact

Last Name: Valerie Valerie Parks, RN OCN, CCRP

Email: [email protected]

Location
Facility: University of New Mexico Comprehensive Cancer Center
Location Countries

United States

Verification Date

2021-05-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

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

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

Label: 2D-Mammogram Recipients (Patient Group B)

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

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

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

Label: Providers

Description: 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

Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Other

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