Test Up Now Education Program

NCT04304001 | Completed Results

• 2 other identifiers: FWA00005391U54MD007582-34A1
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the effectiveness of an outreach strategy to increase colorectal cancer screening in African Americans. The investigators will recruit 250 African Americans ages 45-64 years who are not up-to-date with colorectal cancer screening or have never been screened, with the goal to evaluate screening knowledge, behavior, and intervention effects on colorectal cancer screening outcomes. Participants will be randomly assigned to the TUNE-UP intervention or a control group. The TUNE-UP intervention arm will utilize a community health advisor to encourage return of stool blood testing kits through cell phone outreach. The control group will receive educational materials about colorectal cancer screening plus a resource list but no community health advisor counseling support or cellphone / text contact. The primary study outcome is receipt of colorectal cancer screening (colonoscopy or Fecal Immunochemical Test) following the intervention. The secondary outcomes will include colorectal cancer screening knowledge, self-efficacy (confidence to receive colorectal cancer screening), intention to screen, and follow-up in the case of an abnormal test result. The research objective is to test the community health advisor intervention effectiveness for promoting stool blood testing as a preferred screening test in an under-screened African American population.

Conditions

Colorectal Cancer Screening

Outcome Measures

Primary Outcomes (1)

• Number of Participants Up to Date on Colorectal Cancer Screening

  The colorectal cancer screening measure asks about completion of colonoscopy and blood stool tests. These tests are described prior to questions about completion of each test. The first question asks when was the most recent stool blood test (\> 1 year but \< 2 years ago; \> 2 years but not more than 5 years ago; or \> 5 years). The second question asks when was the most recent colonoscopy (a year ago or less; \> 1 year but \< 5 years ago; \> 5 years but not more than 10 years ago; or \> 10 years). Colorectal cancer screening receipt will be determined based on self-report and chart review to determine screening rates for each screening modality. Those answering a "a year ago or less" for the most recent stool blood test and "less than 10 years ago" for most recent colonoscopy are considered up to date.

  12 months

Secondary Outcomes (2)

• Colorectal Cancer Screening Knowledge Measure

  12 months

• Colorectal Cancer Screening Self-Efficacy Scale

  12 months

Study Arms (2)

Community Health Advisor

EXPERIMENTAL

Intervention arm participants will be scheduled to receive the Community Health Advisor intervention within 4 to 6 weeks after enrollment, a Fecal Immunochemical Test kit, a mailed targeted colorectal cancer brochure, and a follow-up telephone survey at 3- and 12-months post-intervention

Behavioral: Community Health Advisor

Usual care

ACTIVE COMPARATOR

Control group participants will receive a Fecal Immunochemical Test kit, a mailed targeted colorectal cancer brochure, and complete a follow-up telephone survey at 3- and 12-months after the mailing.

Behavioral: Usual care

Interventions

Community Health Advisor BEHAVIORAL

Intervention arm participants will receive one 45-minute face-to-face meeting followed by two phone calls in one-week intervals over a period of three weeks beginning within one month following baseline survey completion. These educational activities will include the use of National Cancer Institute colorectal cancer resources and materials, including a Screen to Save media presentation, and colorectal cancer brochures. The intervention will follow a conversation guide/standard script for intervention fidelity. Community Health Advisors will take notes following each interaction to document the call length and call details. Participants will receive an additional text message reminder once a week for an additional three weeks - with instructions for participants to text "yes" to confirm they received the message - for a total of six weeks of intervention delivery. The personalized text messages will include short messages about the benefits of colorectal cancer screening.

Community Health Advisor

Usual care BEHAVIORAL

Control arm participants will receive a Fecal Immunochemical Test kit, a mailed targeted colorectal cancer brochure, and complete a follow-up telephone survey at 3- and 12-months after the mailing.

Usual care

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• are 45 years to 64 years of age
• self-identify as African American
• have a working cellphone or telephone
• are a resident of Florida
• are non-adherent with colorectal cancer screening guidelines (i.e., no stool-based tests \> 9 months, no colonoscopy within 9 years, and no flexible sigmoidoscopy within 4 years)
• have no personal history of colorectal cancer, precancerous colorectal polyps, or inflammatory bowel disease (ulcerative colitis or Crohn's disease).

You may not qualify if:

• under 45 years or over 64 years of age
• do not self-identify as African American
• do not have a working cellphone or telephone
• not a resident of Florida
• are adherent with colorectal cancer screening guidelines (i.e., stool-based tests \< 9 months, colonoscopy within 9 years, and flexible sigmoidoscopy within 4 years) or
• have a personal history of colorectal cancer, precancerous colorectal polyps, or inflammatory bowel disease (ulcerative colitis or Crohn's disease).

Sponsors & Collaborators

• Florida A&M University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Florida A&M University

Tallahassee, Florida, 323207, United States

Location

Related Publications (2)

• Luque JS, Kiros GE, Vargas MA, Ali A, Tawk R, Jackson DR, Dickey SL, Harris CM, Robinson T, Duncan B, Freeman J, Gwede CK, Wallace K. Effectiveness of a community health advisor colorectal cancer screening educational intervention on stool test completion in an African American primary care patient population: a pragmatic randomized controlled trial. BMC Glob Public Health. 2025 Jun 1;3(1):47. doi: 10.1186/s44263-025-00168-4.

  PMID: 40450376 DERIVED

• Luque JS, Matthew OO, Jackson DR, Vargas MA, Austin T, Ali A, Kiros GE, Harris CM, Tawk R, Gwede CK, Wallace K, Jean-Pierre P. 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. 2022 Feb 15;23(1):151. doi: 10.1186/s13063-022-06076-4.

  PMID: 35168640 DERIVED

Limitations and Caveats

The projected sample size was originally 244. Because of difficulties in recruiting this patient population of African American patients in 2 community health centers who were not up to date with colorectal cancer screening, the study was only able to recruit 115 individuals over the 2 year recruitment period. Therefore, there is smaller number of patients to analyze the effectiveness of the educational intervention, and the study is underpowered.

Results Point of Contact

• Title: Dr. Tanise Jackson, Director of Animal Welfare Research Integrity
• Organization: Florida A&M University

tanise.jackson@famu.edu

850-599-3214

Study Officials

• Karam Soliman, PhD

  Florida A&M University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will complete surveys and receive mailings and not know if they are in control arm or intervention arm.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to the TUNE-UP intervention or a control group that will receive educational materials about colorectal cancer screening plus a resource list but no Community Health Advisor counseling support or cellphone / text contact like in the TUNE-UP Community Health Advisor intervention group.

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: March 11, 2020
• Study Start: April 7, 2021
• Primary Completion: February 12, 2024
• Study Completion: February 12, 2024
• Last Updated: October 29, 2024
• Results First Posted: October 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 3 years following completion of the project
• Access Criteria: Data release will require a fully executed data sharing agreement that will place stipulations on the data that will further protect human subjects. This agreement will include the following: 1. Requirement that the data be used for research purposes only, and not for commercial use 2. Requirement that data will be secured using appropriate computer technology (e.g., password protected computers, firewalls) 3. Requirement that no attempt will be made to identify any individual in the study data, and that if any identification does occur the link allowing such identification will be destroyed 4. Requirement that data not be shared with anyone not included in the original data sharing agreement 5. Requirement that a copy of any resulting publications be forwarded to the Principal Investigator for record-keeping purposes and for archiving as required with NIH 6. Requirement that acknowledgment of the data source be made, as appropriate, within the investigator's publication venue

Locations

US (1)