- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04164251
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
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
|
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
Collaborators
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.
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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