Test Up Now Education Program (TUNE-UP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04304001|
Recruitment Status : Not yet recruiting
First Posted : March 11, 2020
Last Update Posted : March 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Screening||Behavioral: Community Health Advisor Behavioral: Usual care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|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 Description:||Participant will complete surveys and receive mailings and not know if they are in control arm or intervention arm.|
|Official Title:||Test Up Now Education Program|
|Estimated Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||February 29, 2024|
|Estimated Study Completion Date :||February 29, 2024|
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.
- 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.
- 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."
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04304001
|Contact: John S Luque, PhDfirstname.lastname@example.org|
|United States, Florida|
|Florida A&M University|
|Tallahassee, Florida, United States, 323207|
|Contact: John S Luque, PhD 850-561-2054 email@example.com|
|Principal Investigator:||Karam Soliman, PhD||Florida A&M University|