Breast CancerNCT04164251
Inpatient Screening Mammography for Non-adherent and High Risk Women
A study testing Screening mammography in people with Breast Cancer, run by Johns Hopkins University.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Screening mammography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2016
- Phase
- Interventional
- 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 50 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women between 50 and 74 years of age who were non-adherent to breast screening guidelines
Who cannot join
- Patients with a history of breast cancer or mastectomy
- history of other cancers (except skin)
- serious comorbidities making patient's life expectancy <10 years
About this study
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.
- Conditions
- Breast Cancer
- Being tested
- Screening mammography
- Keywords
- Breast Cancer Screening, Mammography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening mammographyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Inpatient screening mammography for non-adherent and high risk | Experimental | All non-adherent women were offered inpatient screening mammography during hospitalization Receives: Other: Screening mammography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Prior to hospital discharge, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study startJan 2015
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Maryland Cigarette Restitution Fund, EQUIP (Excellence in Quality, Utilization of resources, Integration and Patient- centered Care)
- Responsible party
- Sponsor
- Investigators
- Waseem Khaliq, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164251
- Sponsor's protocol ID
- NA_00079826
- Status last verified
- Nov 2019
- First submitted
- 12 Nov 2019
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34229929
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inpatient Screening Mammography for Non-adherent and High Risk Women
- ClinicalTrials.gov ID
- NCT04164251
- Acronym / sponsor ID
- NA_00079826
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer Screening, Mammography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Maryland Cigarette Restitution Fund, EQUIP (Excellence in Quality, Utilization of resources, Integration and Patient- centered Care)
- Study start
- Jan 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inpatient screening mammography for non-adherent and high risk | Experimental | Other: Screening mammographyAll non-adherent women were offered inpatient screening mammography during hospitalization |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women between 50 and 74 years of age who were non-adherent to breast screening guidelines
Key exclusion criteria (3 listed)
- Patients with a history of breast cancer or mastectomy
- history of other cancers (except skin)
- serious comorbidities making patient's life expectancy <10 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening mammographyThe 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. | Other | Inpatient screening mammography for non-adherent and high risk |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- Derived from this study: PubMed 34229929Khaliq 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waseem Khaliq, MD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing Screening mammography in people with Breast Cancer, run by Johns Hopkins University.
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 3 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 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Proportion of women who underwent a screening mammography during hospitalization (time frame: Prior to hospital discharge, up to 1 year). 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 NCT04164251, 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 3 Dec 2019.