Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03979729
Recruitment Status : Recruiting
First Posted : June 7, 2019
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Breast Cancer Screening Other: Routine Screening Mammogram (3D + 2D) Other: Routine Screening Mammogram (2D) Other: No Screening Mammogram

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Other
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
Actual Study Start Date : September 22, 2016
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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)
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.

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)
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.

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

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



Primary Outcome Measures :
  1. Recall rates using 3D + 2D- vs. 2D-mammogram in New Mexico women undergoing screening mammograms (Retrospective analysis) [ Time Frame: 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 :
  1. What psychosocial and cultural factors influence breast cancer screening among medically underserved patients, identified through interviews and questionnaires [ Time Frame: 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.

  2. What are primary care providers' knowledge, attitudes, beliefs, and preferences regarding 3D + 2D- vs. 2D-mammography, identified through interviews and questionnaires [ Time Frame: 5 years ]
    Use interviews to create qualitative (descriptive) assessments of care providers' knowledge, attitudes, beliefs, and preferences regarding 3D + 2D- vs. 2D-mammography.

  3. Breast cancer detection rate for 3D + 2D- vs. 2D-mammograms [ Time Frame: 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.

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

  5. Screening outcome of women undergoing 3-D mammography [ Time Frame: 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.

  6. Compliance with recall recommendations of women undergoing 3-D mammography [ Time Frame: 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.

  7. Breast cancer detection rate in women undergoing 3-D mammography [ Time Frame: 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.

  8. Positive predictive value of women undergoing 3-D mammography [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03979729


Contacts
Layout table for location contacts
Contact: Amy Overby 505-272-5557 Aoverby1@salud.unm.edu
Contact: Karen Gaines, BS 505-925-0353 kgaines@salud.unm.edu

Locations
Layout table for location information
United States, New Mexico
University of New Mexico Comprehensive Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Amy Overby    505-272-5557    Aoverby1@salud.unm.edu   
Contact: Karen Gaines, BS    505-925-0353    kgaines@salud.unm.edu   
Principal Investigator: Stephanie Fine, MD         
Sub-Investigator: Ursa Brown-Glaberman, MD         
Sub-Investigator: Shiraz Mishra, PhD         
Sub-Investigator: Andrew Sussman, PhD         
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Investigators
Layout table for investigator information
Principal Investigator: Stephanie Fine, MD University of New Mexico Comprehensive Cancer Center

Layout table for additonal information
Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT03979729     History of Changes
Other Study ID Numbers: INST UNM 1525
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases