Test Up Now Education Program (TUNE-UP)
Primary Purpose
Colorectal Cancer Screening
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Community Health Advisor
Usual care
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer Screening
Eligibility Criteria
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 CRC 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 CRC 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 CRC 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 CRC cancer, precancerous colorectal polyps, or inflammatory bowel disease (ulcerative colitis or Crohn's disease).
Sites / Locations
- Florida A&M University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Community Health Advisor
Usual care
Arm Description
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
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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."
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."
Full Information
NCT ID
NCT04304001
First Posted
February 24, 2020
Last Updated
May 2, 2023
Sponsor
Florida A&M University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
1. Study Identification
Unique Protocol Identification Number
NCT04304001
Brief Title
Test Up Now Education Program
Acronym
TUNE-UP
Official Title
Test Up Now Education Program
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 7, 2021 (Actual)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
February 29, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Florida A&M University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Screening
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
Participant will complete surveys and receive mailings and not know if they are in control arm or intervention arm.
Allocation
Randomized
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Community Health Advisor
Arm Type
Experimental
Arm Description
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
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Community Health Advisor
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of Colorectal Cancer Screening
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Colorectal Cancer Screening Knowledge Scale
Description
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."
Time Frame
12 months
Title
Colorectal Cancer Screening Self-Efficacy Scale
Description
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."
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 CRC 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 CRC 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 CRC 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 CRC cancer, precancerous colorectal polyps, or inflammatory bowel disease (ulcerative colitis or Crohn's disease).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karam Soliman, PhD
Organizational Affiliation
Florida A&M University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida A&M University
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
323207
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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:
Requirement that the data be used for research purposes only, and not for commercial use
Requirement that data will be secured using appropriate computer technology (e.g., password protected computers, firewalls)
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
Requirement that data not be shared with anyone not included in the original data sharing agreement
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
Requirement that acknowledgment of the data source be made, as appropriate, within the investigator's publication venue
Citations:
PubMed Identifier
35168640
Citation
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.
Results Reference
derived
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Test Up Now Education Program
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