Test Up Now Education Program (TUNE-UP)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Cancer Screening
• Intervention / Treatment: Behavioral: Community Health Advisor; Behavioral: Usual care

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John S Luque, PhD; Phone Number: 850-561-2054; Email: john.luque@famu.edu

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 323207
      • Florida A&M University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 CRC 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 CRC 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 CRC 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 CRC cancer, precancerous colorectal polyps, or inflammatory bowel disease (ulcerative colitis or Crohn's disease).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Community Health Advisor; 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	Behavioral: Community Health Advisor; Intervention arm participants will receive one 45-minute face-to-face meeting followed by two CHA phone calls in one-week intervals over a period of three weeks beginning within one month following baseline survey completion. These CRC educational activities delivered by the CHAs will include the use of NCI CRC resources and materials, including an S2S PowerPoint presentation, and CRC educational brochures. The intervention will follow a conversation guide/standard script for intervention fidelity. CHAs will take notes following each interaction to document the call length, deviations from the script, and tone of the call. 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 have positive tones and include short messages about the benefits of CRC screening.
Active Comparator: Usual care; 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.	Behavioral: Usual care; Control arm participants will receive a FIT kit, a mailed targeted colorectal cancer brochure, and complete a follow-up telephone survey at 3- and 12-months after the mailing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Colorectal Cancer Screening Knowledge Scale	Participants are asked four True/False questions about colon cancer: if their chance of getting colon cancer is higher if they have a family history, if it can be cured if caught early, if colon cancer is associated with pain or other symptoms, and if a warning sign of colon cancer is having a rash. They are also asked six additional True/False questions later in the survey to test knowledge about colorectal cancer screening. The range of the scale is 0-10. Each answer is scored as correct or incorrect. A score of 7 to 10 is considered "high". A score of 4 to 6 is considered "average". A score of 0 to 3 is considered "low."	12 months
Colorectal Cancer Screening Self-Efficacy Scale	A validated 4-item measure of colorectal cancer screening self-efficacy (alpha = 0.82) asks participants to respond using a Likert scale about colorectal cancer screening test difficulty, finding time, ease of completing the test, and scheduling the test. Total scale scores range from 1 to 4. A score of 3 to 4 is considered "low self-efficacy" and a score of 1 to 2 is considered "high self-efficacy."	12 months

Collaborators and Investigators

• Sponsor: Florida A&M University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Karam Soliman, PhD, Florida A&M University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2021
• Primary Completion (Anticipated): February 29, 2024
• Study Completion (Anticipated): February 29, 2024

Study Registration Dates

• First Submitted: February 24, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (Actual): March 11, 2020

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: FWA00005391; U54MD007582-34A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Data sharing will be overseen by the Principal Investigator. To facilitate sharing of data, study outcome publications from this CRC screening intervention study will provide email contact information for interested persons to obtain details on accessing de-identified data. The data sharing option will be available for at least 3 years following completion of the project, consistent with NIH policy on maintenance of study data.

The investigator requesting the data will be required to submit a data request detailing the research question to be investigated, the specific variables necessary for the intended analyses, a list of individuals who will have access to the data, and proof of adequate training in the protection of human subjects for all individuals with access to data.

• IPD Sharing Time Frame: 3 years following completion of the project

IPD Sharing 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

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No