Cancer ScreeningNCT04162925
Cancer Screening Utilization Rates and Cancer Screening Perspectives of Hospitalized Women
A study testing Cancer screening education for breast, colon and oral cancers in people with Cancer Screening, run by Johns Hopkins University.
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. Read more about this study
- Who is it for?
- Ages 50 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer Screening
- What is being tested?
- Cancer screening education for breast, colon and oral cancers
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to 1 Dec 2022
- 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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- chronic kidney disease on hemodialysis
- history of BRCA1 or BRCA2 gene mutation
- current admission for cellulitis or abscess of breast
About this study
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.
Read more
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.
- Conditions
- Cancer Screening
- Being tested
- Cancer screening education for breast, colon and oral cancers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer screening education for breast, colon and oral cancersBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cancer screening education for breast, colon and oral cancers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study startDec 2014
- Primary completionDec 2017
- Study completion1 Dec 2022
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 Cancer ScreeningStudies 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
- Model description
- Cancer screening utilization rates and cancer screening perspective of hospitalized women on internal medicine service
- Masking
- None (open label)
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- State of Maryland
- Responsible party
- Sponsor
- Investigators
- Waseem Khaliq, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162925
- Sponsor's protocol ID
- IRB00049608
- Other IDs
- IO90059879
- Status last verified
- Dec 2022
- First submitted
- 12 Nov 2019
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36185070
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Screening Utilization Rates and Cancer Screening Perspectives of Hospitalized Women
- ClinicalTrials.gov ID
- NCT04162925
- Acronym / sponsor ID
- IRB00049608
- Conditions
- Cancer Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- State of Maryland
- Study start
- Dec 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 14 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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cancer screening utilization rates and cancer screening perspective of hospitalized women on internal medicine service
| Arm | Type | Receives |
|---|---|---|
| Cancer screening cohort | Experimental | Behavioral: Cancer screening education for breast, colon and oral cancersAll 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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
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 |
|---|---|---|
| Cancer screening education for breast, colon and oral cancersBedside 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 | Behavioural | Cancer screening cohort |
Primary outcome
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.
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.
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.
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
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
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.
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
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
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
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 8 Dec 2022.
- Derived from this study: PubMed 36185070Olayinka 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.
- 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 Cancer screening education for breast, colon and oral cancers in people with Cancer Screening, 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 3 inclusion and 9 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 8 Dec 2022. 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 non-adherent to breast cancer screening in this group (time frame: 3 years). The study lists 9 primary outcomes in all. 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 NCT04162925, 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 8 Dec 2022.