NCT04162925

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 14, 2019

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 8, 2022

Status Verified

December 1, 2022

Enrollment Period

3 years

First QC Date

November 12, 2019

Last Update Submit

December 7, 2022

Conditions

Outcome Measures

Primary Outcomes (9)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

Cancer screening cohort

EXPERIMENTAL

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.

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

Interventions

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

Cancer screening cohort

Eligibility Criteria

Age50 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailshospitalized women between ages of 50-75 who will be cancer free at the time of enrollment (except for skin cancer)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Olayinka O, Gnanaraj J, Khaliq W. Hospitalized Women's Willingness to Pay for Inpatient Screening Colonoscopy. Womens Health Rep (New Rochelle). 2022 Sep 13;3(1):768-773. doi: 10.1089/whr.2022.0014. eCollection 2022.

Study Officials

  • Waseem Khaliq, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Cancer screening utilization rates and cancer screening perspective of hospitalized women on internal medicine service
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2019

First Posted

November 14, 2019

Study Start

December 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2022

Last Updated

December 8, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share