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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04162925
Other study ID # IRB00049608
Secondary ID IO90059879
Status Completed
Phase N/A
First received
Last updated
Start date December 2014
Est. completion date December 1, 2022

Study information

Verified date December 2022
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 700
Est. completion date December 1, 2022
Est. primary completion date December 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 50 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Cancer screening education for breast, colon and oral cancers
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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins University State of Maryland

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of women non-adherent to breast cancer screening in this group Proportion of women non-adherent to breast cancer screening will be assessed in these hospitalized women. 3 years
Primary Prevalence of breast cancer screening post intervention in this group Prevalence of breast cancer screening post intervention will be assessed in these hospitalized women. 3 years
Primary Proportion of hospitalized women non-adherent to colon cancer screening Proportion of hospitalized women non-adherent to colon cancer screening will be assessed in these hospitalized women. 3 years
Primary Perspective of hospitalized women about colon cancer screening as assessed by multiple choice questions survey of hospitalized women using multiple choice 21 questions 3 years
Primary Perspective of hospitalized women about colon cancer screening as assessed by likert scale 21 questions survey of hospitalized women using likert scale 21 questions 3 years
Primary Proportion of women non-adherent to oral cancer screening Proportion of women non-adherent to oral cancer screening will be assessed in these hospitalized women. 3 years
Primary Number of women agreeable to inpatient oral cancer screening exam oral cavity screening exam consisting of mouth and neck examination by hospital providers 3 years
Primary Perspective of hospitalized women in general about their preference for cancers screening as assessed by multiple choice questions a survey consisting of 55 multiple choice questions 3 years
Primary Perspective of hospitalized women in general about their preference for cancers screening as assessed by likert scale a survey with a likert scale 3 years
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