Inpatient Screening Mammography for Non-adherent and High Risk Women

November 30, 2019 updated by: Johns Hopkins University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inpatient screening mammography for non-adherent and high risk
All non-adherent women were offered inpatient screening mammography during hospitalization
Other: Screening mammography
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of women who underwent a screening mammography during hospitalization
Time Frame: Prior to hospital discharge, up to 1 year
Screening mammography is done during hospitalization. Proportion of women that get the screening will be assessed.
Prior to hospital discharge, up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Maryland Cigarette Restitution Fund
EQUIP (Excellence in Quality, Utilization of resources, Integration and Patient- centered Care)

Investigators

  • Principal Investigator: Waseem Khaliq, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

November 12, 2019

First Submitted That Met QC Criteria

November 12, 2019

First Posted (Actual)

November 15, 2019

Study Record Updates

Last Update Posted (Actual)

December 3, 2019

Last Update Submitted That Met QC Criteria

November 30, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00079826

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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