Back to resultsInpatient Screening Mammography for Non-adherent and High Risk Women
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Screening mammography
Sponsored by
About this trial
This is an interventional health services research trial for Breast Cancer focused on measuring Breast Cancer Screening, Mammography
Eligibility Criteria
Inclusion Criteria:
- women between 50 and 74 years of age who were non-adherent to breast screening guidelines
Exclusion Criteria:
- Patients with a history of breast cancer or mastectomy
- history of other cancers (except skin)
- serious comorbidities making patient's life expectancy <10 years
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Inpatient screening mammography for non-adherent and high risk
Arm Description
All non-adherent women were offered inpatient screening mammography during hospitalization
Outcomes
Primary Outcome Measures
Proportion of women who underwent a screening mammography during hospitalization
Screening mammography is done during hospitalization. Proportion of women that get the screening will be assessed.
Secondary Outcome Measures
Full Information
NCT ID
NCT04164251
First Posted
November 12, 2019
Last Updated
November 30, 2019
Sponsor
Johns Hopkins University
Collaborators
Maryland Cigarette Restitution Fund, EQUIP (Excellence in Quality, Utilization of resources, Integration and Patient- centered Care)
1. Study Identification
Unique Protocol Identification Number
NCT04164251
Brief Title
Inpatient Screening Mammography for Non-adherent and High Risk Women
Official Title
Inpatient Screening Mammography for Non-adherent and High Risk Women
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Maryland Cigarette Restitution Fund, EQUIP (Excellence in Quality, Utilization of resources, Integration and Patient- centered Care)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators propose to pilot a program that will evaluate the feasibility of an inpatient screening mammography for non-adherent and high risk hospitalized women age 52-74 admitted to the medicine services at Johns Hopkins Bayview Medical Center and Howard County General Hospital. The two key activities include: inpatient breast care education with educational handouts and offering inpatient screening mammography. Inpatient screening mammography will be offered to non-adherent (last screening mammogram more than 24 months ago) and high risk (Gail 5-year risk of breast cancer 1.6 or greater) women. This pilot program will thus evaluate the feasibility of an inpatient screening mammography as an innovative approach to increase breast cancer screening among non-adherent and high risk women.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer Screening, Mammography
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inpatient screening mammography for non-adherent and high risk
Arm Type
Experimental
Arm Description
All non-adherent women were offered inpatient screening mammography during hospitalization
Intervention Type
Other
Intervention Name(s)
Screening mammography
Intervention Description
The purpose of the study was to evaluate the feasibility of securing inpatient breast cancer screening mammograms for non-adherent hospitalized women prior to hospital discharge.
Primary Outcome Measure Information:
Title
Proportion of women who underwent a screening mammography during hospitalization
Description
Screening mammography is done during hospitalization. Proportion of women that get the screening will be assessed.
Time Frame
Prior to hospital discharge, up to 1 year
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
women between 50 and 74 years of age who were non-adherent to breast screening guidelines (USPSTF recommendations)
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
women between 50 and 74 years of age who were non-adherent to breast screening guidelines
Exclusion Criteria:
Patients with a history of breast cancer or mastectomy
history of other cancers (except skin)
serious comorbidities making patient's life expectancy <10 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waseem Khaliq, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34229929
Citation
Khaliq W, Siferd C, Kantsiper ME, Jacobs L, Howell EE, Wright SM. Capturing the Rest: Inpatient Mammography for Nonadherent Hospitalized Women. Am J Prev Med. 2021 Nov;61(5):709-715. doi: 10.1016/j.amepre.2021.04.026. Epub 2021 Jul 4.
Results Reference
derived
Learn more about this trial
Inpatient Screening Mammography for Non-adherent and High Risk Women
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