- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04162925
Cancer Screening Utilization Rates and Cancer Screening Perspectives of Hospitalized Women
Breast and colon cancers are commonly diagnosed cancers among women after skin cancer in Maryland. Patients' preferences for cancer screening are known to significantly influence utilization, and thus impact health outcomes. In a recent study the investigators conducted at Johns Hopkins Bayview Medical Center, the investigators observed that among women age 50-75 years admitted to general medicine services over 4-month period, 40% were non-adherent to breast cancer screening (overdue) despite being insured.
Therefore, the investigators propose to establish a cohort of hospitalized women to help the investigators develop successful interventions for enhancing breast cancer screening utilization in this group. In following a cohort prospectively, the investigators intend to both reaffirm the results from the investigators' previous study and determine whether the patterns of mammographic screening improve over time as a result of the investigators' interventions. Among non-adherent (overdue) women, the investigators will educate and encourage these women to undergo outpatient screening mammography.
To more comprehensively assess the preventive health in this cohort, the investigators will assess the cohort's adherence to colon cancer screening recommendation and barriers to colon cancer screening.
In addition the investigators will also like to encourage the hospitalists and house staff taking care of these patients to perform oral cancer screen among women who smoke (non-adherent to breast cancer screening) Finally the investigators will also like to ask the perspective of cancer screening among these women.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women between the ages of 50 to 75 years admitted to medicine service at Johns Hopkins Bayview Medical Center
- cancer free at baseline (excluding skin cancers)
- willing to participate voluntarily
Exclusion Criteria:
- history of breast cancer or mastectomy
- history of other cancers (except skin) or serious comorbidities making life expectancy <10 years
- pregnancy
- dementia
- chronic disability (unable to stand or nursing home resident)
- current admission because of acute coronary event (heart attack) or stroke or pulmonary embolism
- chronic kidney disease on hemodialysis
- history of BRCA1 or BRCA2 gene mutation
- current admission for cellulitis or abscess of breast
Study Plan
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: Cancer screening cohort
All women in this study to be evaluated for cancer screening utilization rates (breast, colon and oral cancers) and cancer screening perspectives of these hospitalized women. The intervention will be a cancer screening education. |
Bedside education one-on-one by showing screening video and handouts at the end of educational session for breast, colon and oral cancer.
Patient who are agreeable to oral cancer screen during hospitalization perform oral cancer screening
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of women non-adherent to breast cancer screening in this group
Time Frame: 3 years
|
Proportion of women non-adherent to breast cancer screening will be assessed in these hospitalized women.
|
3 years
|
Prevalence of breast cancer screening post intervention in this group
Time Frame: 3 years
|
Prevalence of breast cancer screening post intervention will be assessed in these hospitalized women.
|
3 years
|
Proportion of hospitalized women non-adherent to colon cancer screening
Time Frame: 3 years
|
Proportion of hospitalized women non-adherent to colon cancer screening will be assessed in these hospitalized women.
|
3 years
|
Perspective of hospitalized women about colon cancer screening as assessed by multiple choice questions
Time Frame: 3 years
|
survey of hospitalized women using multiple choice 21 questions
|
3 years
|
Perspective of hospitalized women about colon cancer screening as assessed by likert scale 21 questions
Time Frame: 3 years
|
survey of hospitalized women using likert scale 21 questions
|
3 years
|
Proportion of women non-adherent to oral cancer screening
Time Frame: 3 years
|
Proportion of women non-adherent to oral cancer screening will be assessed in these hospitalized women.
|
3 years
|
Number of women agreeable to inpatient oral cancer screening exam
Time Frame: 3 years
|
oral cavity screening exam consisting of mouth and neck examination by hospital providers
|
3 years
|
Perspective of hospitalized women in general about their preference for cancers screening as assessed by multiple choice questions
Time Frame: 3 years
|
a survey consisting of 55 multiple choice questions
|
3 years
|
Perspective of hospitalized women in general about their preference for cancers screening as assessed by likert scale
Time Frame: 3 years
|
a survey with a likert scale
|
3 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Waseem Khaliq, MD, Johns Hopkins University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB00049608
- IO90059879 (Other Grant/Funding Number: State of Maryland)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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