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Community Health Advisor Support for Colorectal Cancer Screening (TUNE-UP Trial)

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Waitlist Available

Led By Karam Soliman, PhD

Research Sponsored by Florida A&M University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

are 45 years to 64 years of age

have no personal history of CRC cancer, precancerous colorectal polyps, or inflammatory bowel disease (ulcerative colitis or Crohn's disease).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

TUNE-UP Trial Summary

This trial will test whether or not an outreach strategy can increase colorectal cancer screening rates in African Americans. The study will recruit 250 participants who will be randomly assigned to either the intervention or control group. The intervention group will receive support from a community health advisor to encourage them to return stool blood testing kits, while the control group will only receive educational materials about CRC screening. The primary outcome of the study is whether or not participants in the intervention group are more likely to receive CRC screening than those in the control group.

Who is the study for?

This trial is for African Americans aged 45-64 living in Florida who haven't kept up with colorectal cancer (CRC) screening guidelines and have no history of CRC, precancerous polyps, or inflammatory bowel disease. They must have a working cellphone or telephone.Check my eligibility

What is being tested?

The study tests if a community health advisor can boost CRC screening rates through phone outreach compared to usual care with educational materials. Participants will be randomly placed into two groups to compare the effectiveness of these strategies.See study design

What are the potential side effects?

Since this trial involves education and counseling rather than medication, there are no direct medical side effects. However, participants may experience anxiety or stress related to discussing their health and undergoing CRC screenings.

TUNE-UP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 45 and 64 years old.

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I have never had colorectal cancer, precancerous polyps, or inflammatory bowel disease.

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I am between 45 and 64 years old.

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I have never had colorectal cancer, precancerous polyps, or inflammatory bowel disease.

TUNE-UP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of Colorectal Cancer Screening

Secondary outcome measures

Colorectal Cancer Screening Knowledge Scale

Colorectal Cancer Screening Self-Efficacy Scale

TUNE-UP Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Community Health AdvisorExperimental Treatment1 Intervention

Intervention arm participants will be scheduled to receive the CHA intervention within 4 to 6 weeks after enrollment, a FIT kit, a mailed targeted CRC brochure, and a follow-up telephone survey at 3- and 12-months post-intervention

Group II: Usual careActive Control1 Intervention

Control group participants will receive a FIT kit, a mailed targeted CRC brochure, and complete a follow-up telephone survey at 3- and 12-months after the mailing.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Minority Health and Health Disparities (NIMHD)NIH

382 Previous Clinical Trials

1,216,046 Total Patients Enrolled

Florida A&M UniversityLead Sponsor

5 Previous Clinical Trials

4,470 Total Patients Enrolled

Karam Soliman, PhDPrincipal InvestigatorFlorida A&M University

Media Library

Community Health Advisor (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT04304001 — N/A

Colorectal Cancer Screening Research Study Groups: Usual care, Community Health Advisor

Colorectal Cancer Screening Clinical Trial 2023: Community Health Advisor Highlights & Side Effects. Trial Name: NCT04304001 — N/A

Community Health Advisor (N/A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04304001 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people of a younger age range appropriate for this experiment?

"The parameters for eligibility in this trial necessitate that applicants must be between 45 and 64 years of age. There are a total of 30 trials available to people younger than 18 while 847 studies exist specifically targeting those aged 65 or over."

Answered by AI

Does this research initiative offer enrolment opportunities at present?

"Per information available on clinicaltrials.gov, enrolment for this medical experiment is still underway. Initially posted in April of 2021, the trial has since been updated as recently as January 25th 2022."

Answered by AI

How many individuals are involved in this experiment?

"Affirmative. Data on clinicaltrials.gov states that this trial is still enrolling participants, with the first posting taking place April 7th 2021 and an update made January 25th 2022. This medical study requires 250 people from a single site to participate in the research."

Answered by AI

What criteria should a person meet in order to be eligible for enrollment into this clinical experiment?

"This medical trial is searching for 250 individuals aged 45 to 64 who have been diagnosed with colorectal cancer. To qualify, patients must possess a working cellular or landline device, not exhibit compliance with CRC testing recommendations (no stool-based tests > 9 months, no colonoscopy within 9 years and no flexible sigmoidoscopy 4 years prior), lack any personal history of CRC cancer or precancerous polyps in the colonic region as well as inflammatory bowel disease such as ulcerative colitis or Crohn's disease."

Answered by AI

Recent research and studies

TrialsJournal

Assessing the Effectiveness of a Community Health Advisor Plus Screen to Save Educational Intervention on Stool-based Testing Adherence in an African American Safety Net Clinic Population: Study Protocol for a Randomized Pragmatic Trial

Luque, John S., Olayemi O. Matthew, Deloria R. Jackson, Matthew A. Vargas, Tifini Austin, Askal Ali, Gebre E. Kiros, et al.. 2022. “Assessing the Effectiveness of a Community Health Advisor Plus Screen to Save Educational Intervention on Stool-based Testing Adherence in an African American Safety Net Clinic Population: Study Protocol for a Randomized Pragmatic Trial”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-022-06076-4.

clinicaltrials.govStudy

Test Up Now Education Program

2021. "Test Up Now Education Program". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04304001.