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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05107661
Other study ID # IRB-2021-03
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date September 26, 2021
Est. completion date August 9, 2023

Study information

Verified date December 2022
Source Virtua Health, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 62
Est. completion date August 9, 2023
Est. primary completion date August 9, 2023
Accepts healthy volunteers
Gender All
Age group 45 Years to 64 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Telephone Prompt
Scripted messaging to remind subjects to complete their colorectal screening (colonoscopy or fecal test)

Locations

Country Name City State
United States Virtua Health Voorhees New Jersey

Sponsors (2)

Lead Sponsor Collaborator
Virtua Health, Inc. Rutgers University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary : Colorectal Screening Strategies in the High Risk Medically Underserved Population in a Hospital-based Community Outreach Program 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 Colorectal Screening Strategies in the High Risk Medically Underserved Population in a Hospital-based Community Outreach Program Which colorectal screening intervention is preferred in the target population: Colonoscopy versus occult fecal testing in the targeted population
Out comes will be measured by:
Percentage rates of which screening method is selected by the participant: colonoscopy vs. fecal testing.
Percentage rates for following through with completing the screening colonoscopy versus occult fecal testing in the targeted population
3 month intervals
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