Test Up Now Education Program

Colorectal Cancer Screening Clinical Trial

— TUNE-UP  

Official title:

Test Up Now Education Program

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04304001
• Other study ID #: FWA00005391
• Secondary ID: U54MD007582-34A1
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 7, 2021
• Est. completion date: February 29, 2024

Study information

• Verified date: May 2023
• Source: Florida A&M University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 115
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 64 Years

Eligibility

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).

Related Conditions & MeSH terms

• Colorectal Cancer Screening
• Colorectal Neoplasms

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.
• 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.

Locations

Country	Name	City	State
United States	Florida A&M University	Tallahassee	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida A&M University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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