AzTrials
AzTrials

Breast Cancer ScreeningNCT03979729

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

An observational study of Breast Cancer Screening, run by New Mexico Cancer Research Alliance at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 40 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer Screening
What is being tested?
Routine Screening Mammogram (3D + 2D), Routine Screening Mammogram (2D) and No Screening Mammogram
How many people
12 participants
Where
1 siteUnited States
Study dates
22 Sep 2016to 3 Jun 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of New Mexico Comprehensive Cancer Center

    Albuquerque, New Mexico, 87131

Other trials in United States

About this study

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

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).

Read the 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.

Being tested
Routine Screening Mammogram (3D + 2D), Routine Screening Mammogram (2D), No Screening Mammogram

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

  • No Screening MammogramOther

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

Study groups in NCT03979729
Study groupRoleWhat they receive
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.
Receives: 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.
Receives: 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.
Receives: Other: No Screening Mammogram
ProvidersPrimary 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 5 years

Secondary outcomes (8)
  1. What psychosocial and cultural factors influence breast cancer screening among medically underserved patients, identified through interviews and questionnaires

    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.

    Measured: 5 years

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

    Use interviews to create qualitative (descriptive) assessments of care providers' knowledge, attitudes, beliefs, and preferences regarding 3D + 2D- vs. 2D-mammography.

    Measured: 5 years

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

    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.

    Measured: 5 years

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

    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.

    Measured: 5 years

  5. Screening outcome of women undergoing 3-D mammography

    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.

    Measured: 5 years

  6. Compliance with recall recommendations of women undergoing 3-D mammography

    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.

    Measured: 5 years

  7. Breast cancer detection rate in women undergoing 3-D mammography

    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.

    Measured: 5 years

  8. Positive predictive value of women undergoing 3-D mammography

    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.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2019
  2. Study start22 Sep 2016
  3. Primary completion7 May 2020
  4. Study completion3 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03979729
Sponsor's protocol ID
INST UNM 1525
Status last verified
Oct 2026
First submitted
13 May 2019
Last updated
22 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32991242

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer Screening, run by New Mexico Cancer Research Alliance at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recall rates using 3D + 2D- vs. 2D-mammogram in New Mexico women undergoing screening mammograms (Retrospective analysis) (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03979729, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in