Colorectal Screening Strategies in Underserved Populations
August 10, 2023 updated by: Virtua Health, Inc.
Colorectal Screening Strategies in the High Risk Medically Underserved Population in a Hospital-based Community Outreach Program
Research efforts are necessary to identify strategies to increase colorectal screening in underserved patient populations.
Racial, ethnic minorities and medically underserved individuals continue to experience disparities in colorectal cancer mortality despite the availability of screening tests that can detect tumors early when treatments are most effective.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
To determine the effectiveness of completion of colorectal cancer screening through fecal testing for blood and/or colonoscopies as a screening intervention utilizing digital reminders versus telephone prompts and reminders in economically disadvantaged minority communities as part of a colorectal screening outreach program.
Study Type
Observational
Enrollment (Actual)
62
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New Jersey
-
Voorhees, New Jersey, United States, 08043
- Virtua Health
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 64 years (Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
The target population is economically disadvantaged minority, medically underserved individuals that meet eligibility requirements for participation in the New Jersey Cancer Education Early Detection Program.
Description
Inclusion Criteria:
- Any Gender
- 45-64 years of age
- Able to sign the informed consent form
Meets eligibility criteria to participate in New Jersey Cancer Education Early Detection Community Outreach Program
- Uninsured/underinsured
- Household income <250% Federal Poverty Level
- Must be New Jersy resident
- Must have Smart phone
- Must speak English or Spanish
Exclusion Criteria:
- History of colon cancer, colon/rectal polyps and rectal bleeding
- Individuals with Dementia
- ECOG Performance Status 3-4
- Prior Colonoscopy within past 10 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Telephone Prompt
Following consent, the Research Team will call participants three times in the first month (within the first week of signing consent at week 2 and repeated at week 3) and then one time per month for the following two months with scripted messaging reminding the participant to complete the screening activity (colonoscopy or fecal test).
Interpreter services via phone will be utilized for non-English speaking participants.
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Scripted messaging to remind subjects to complete their colorectal screening (colonoscopy or fecal test)
Other Names:
|
|
Digital Prompt
Following consent, scripted messaging will be sent three times in the first month (within the first week of signing consent at week 2 and repeated at week 3) and then once time per month for the following two months with scripted messaging reminding the participant to complete the screening activity (colonoscopy or fecal test).
Digital prompts will be available in Spanish and English.
|
Scripted messaging to remind subjects to complete their colorectal screening (colonoscopy or fecal test)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
: Colorectal Screening Strategies in the High Risk Medically Underserved Population in a Hospital-based Community Outreach Program
Time Frame: 3 month intervals
|
To determine the effectiveness of digital reminders versus telephone reminders to prompt participants to follow through with completing their colonoscopy.
Comparison of the success or failure of digital versus phone call reminders will be measured.
To determine the effectiveness of digital reminders versus phone reminders to follow through with completing fecal testing to screen for colorectal cancer.
Comparison of the success or failure of digital versus phone call reminders will be measured.
|
3 month intervals
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Colorectal Screening Strategies in the High Risk Medically Underserved Population in a Hospital-based Community Outreach Program
Time Frame: 3 month intervals
|
Which colorectal screening intervention is preferred in the target population: Colonoscopy versus occult fecal testing in the targeted population
|
3 month intervals
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 26, 2021
Primary Completion (Actual)
August 9, 2023
Study Completion (Actual)
August 9, 2023
Study Registration Dates
First Submitted
October 5, 2021
First Submitted That Met QC Criteria
October 25, 2021
First Posted (Actual)
November 4, 2021
Study Record Updates
Last Update Posted (Actual)
August 14, 2023
Last Update Submitted That Met QC Criteria
August 10, 2023
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-2021-03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.