Colorectal Screening Strategies in Underserved Populations

Colorectal Cancer Clinical Trial

Official title:

Colorectal Screening Strategies in the High Risk Medically Underserved Population in a Hospital-based Community Outreach Program

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05107661
• Other study ID #: IRB-2021-03
• Status: Terminated
• 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
• 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
• 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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

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