Test Up Now Education Program

NCT ID: NCT04304001

Last Updated: 2024-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-07
• Study Completion Date: 2024-02-12

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Community Health Advisor

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

Group Type: EXPERIMENTAL

Community Health Advisor

Intervention Type: 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.

Usual care

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.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: 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.

Interventions

Community Health Advisor

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.

Intervention Type: BEHAVIORAL

Usual care

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. are 45 years to 64 years of age

2. self-identify as African American

3. have a working cellphone or telephone

4. are a resident of Florida

5. 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)

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

Exclusion Criteria

1. under 45 years or over 64 years of age

2. do not self-identify as African American

3. do not have a working cellphone or telephone

4. not a resident of Florida

5. 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

6. have a personal history of colorectal cancer, precancerous colorectal polyps, or inflammatory bowel disease (ulcerative colitis or Crohn's disease).

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Florida A&M University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karam Soliman, PhD

Role: PRINCIPAL_INVESTIGATOR

Florida A&M University

Locations

Florida A&M University

Tallahassee, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40450376 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35168640 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

U54MD007582-34A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FWA00005391

Identifier Type: -

Identifier Source: org_study_id