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Completed

NCT Number: NCT04304001

Test Up Now Education Program

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.

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Key information

Conditions

Colorectal Cancer Screening

Age range

45 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida A&M University

Tallahassee, Florida, 323207, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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).

Treatment and study plan

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.

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.

Primary outcomes

  1. Number of Participants Up to Date on Colorectal Cancer Screening

    Time frame: 12 months

    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.

Secondary outcomes

  1. Colorectal Cancer Screening Knowledge Measure

    Time frame: 12 months

    Participants are asked four multiple choice questions and 10 True/False questions to test knowledge about colorectal cancer and colorectal cancer screening. The range of the scale is 0-14. Each answer is scored as correct or incorrect. A score of 11 to 14 is considered "high". A score of 7 to 10 is considered "average". A score less than 7 is considered "low."

  2. Colorectal Cancer Screening Self-Efficacy Scale

    Time frame: 12 months

    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."

Sponsors and collaborators

Lead sponsor

Florida A&M University

Other

Collaborators

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

Registry information

Acronym: TUNE-UP

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 11, 2020
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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