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Test Up Now Education Program (TUNE-UP)

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ClinicalTrials.gov Identifier: NCT04304001
Recruitment Status : Not yet recruiting
First Posted : March 11, 2020
Last Update Posted : March 12, 2020
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Florida A&M University

Tracking Information
First Submitted Date  ICMJE February 24, 2020
First Posted Date  ICMJE March 11, 2020
Last Update Posted Date March 12, 2020
Estimated Study Start Date  ICMJE October 1, 2020
Estimated Primary Completion Date February 29, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2020)
Rate of 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2020)
  • Colorectal Cancer Screening Knowledge Scale [ Time Frame: 12 months ]
    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."
  • 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."
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Test Up Now Education Program
Official Title  ICMJE Test Up Now Education Program
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants will be randomly assigned to the TUNE-UP intervention or a control group that will receive educational materials about CRC screening plus a resource list but no Community Health Advisor (CHA) counseling support or cellphone / text contact like in the TUNE-UP CHA intervention group.
Masking: Single (Participant)
Masking Description:
Participant will complete surveys and receive mailings and not know if they are in control arm or intervention arm.
Primary Purpose: Screening
Condition  ICMJE Colorectal Cancer Screening
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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
    Intervention: Behavioral: Community Health Advisor
  • 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.
    Intervention: Behavioral: Usual care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 10, 2020)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 29, 2024
Estimated Primary Completion Date February 29, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: John S Luque, PhD 850-561-2054 john.luque@famu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04304001
Other Study ID Numbers  ICMJE FWA00005391
U54MD007582-34A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Florida A&M University
Study Sponsor  ICMJE Florida A&M University
Collaborators  ICMJE National Institute on Minority Health and Health Disparities (NIMHD)
Investigators  ICMJE
Principal Investigator: Karam Soliman, PhD Florida A&M University
PRS Account Florida A&M University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP