NCT05107661

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
terminated

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

September 26, 2021

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 4, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2023

Completed
Last Updated

August 14, 2023

Status Verified

December 1, 2022

Enrollment Period

1.9 years

First QC Date

October 5, 2021

Last Update Submit

August 10, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • : 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 Outcomes (1)

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

    3 month intervals

Study Arms (2)

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.

Behavioral: Telephone Prompt

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.

Behavioral: Telephone Prompt

Interventions

Scripted messaging to remind subjects to complete their colorectal screening (colonoscopy or fecal test)

Also known as: Digital Prompt
Digital PromptTelephone Prompt

Eligibility Criteria

Age45 Years - 64 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • Any Gender
  • 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

You may not qualify if:

  • History of colon cancer, colon/rectal polyps and rectal bleeding
  • Individuals with Dementia
  • ECOG Performance Status 3-4
  • Prior Colonoscopy within past 10 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virtua Health

Voorhees Township, New Jersey, 08043, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2021

First Posted

November 4, 2021

Study Start

September 26, 2021

Primary Completion

August 9, 2023

Study Completion

August 9, 2023

Last Updated

August 14, 2023

Record last verified: 2022-12

Locations