Trial Outcomes & Findings for Test Up Now Education Program (NCT NCT04304001)
NCT ID: NCT04304001
Last Updated: 2024-10-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
115 participants
Primary outcome timeframe
12 months
Results posted on
2024-10-29
Participant Flow
Participant milestones
| Measure |
Community Health Advisor
Intervention arm participants will be scheduled to receive the Community Health Advisor intervention within 4 to 6 weeks after enrollment, a Fecal Immunochemical Test kit, a mailed targeted colorectal cancer brochure, and a follow-up telephone survey at 3- and 12-months post-intervention
Community Health Advisor: Intervention arm participants will receive one 45-minute face-to-face meeting followed by two Community Health Advisor phone calls in one-week intervals over a period of three weeks beginning within one month following baseline survey completion. These colorectal cancer educational activities delivered by the Community Health Advisors will include the use of National Cancer Institute colorectal cancer resources and materials, including an Screen to Save media presentation, and colorectal cancer educational 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, 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 colorectal cancer screening.
|
Usual Care
Control group 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.
Usual care: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
57
|
|
Overall Study
COMPLETED
|
45
|
48
|
|
Overall Study
NOT COMPLETED
|
13
|
9
|
Reasons for withdrawal
| Measure |
Community Health Advisor
Intervention arm participants will be scheduled to receive the Community Health Advisor intervention within 4 to 6 weeks after enrollment, a Fecal Immunochemical Test kit, a mailed targeted colorectal cancer brochure, and a follow-up telephone survey at 3- and 12-months post-intervention
Community Health Advisor: Intervention arm participants will receive one 45-minute face-to-face meeting followed by two Community Health Advisor phone calls in one-week intervals over a period of three weeks beginning within one month following baseline survey completion. These colorectal cancer educational activities delivered by the Community Health Advisors will include the use of National Cancer Institute colorectal cancer resources and materials, including an Screen to Save media presentation, and colorectal cancer educational 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, 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 colorectal cancer screening.
|
Usual Care
Control group 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.
Usual care: 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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
13
|
9
|
Baseline Characteristics
Test Up Now Education Program
Baseline characteristics by cohort
| Measure |
Community Health Advisor
n=58 Participants
Intervention arm participants will be scheduled to receive the Community Health Advisor intervention within 4 to 6 weeks after enrollment, a Fecal Immunochemical Test kit, a mailed targeted colorectal cancer brochure, and a follow-up telephone survey at 3- and 12-months post-intervention
Community Health Advisor: Intervention arm participants will receive one 45-minute face-to-face meeting followed by two Community Health Advisor phone calls in one-week intervals over a period of three weeks beginning within one month following baseline survey completion. These colorectal cancer educational activities delivered by the Community Health Advisors will include the use of National Cancer Institute colorectal cancer resources and materials, including a Screen to Save media presentation, and colorectal cancer educational 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, 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 colorectal cancer screening.
|
Usual Care
n=57 Participants
Control group 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.
Usual care: 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.
|
Total
n=115 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.38 years
STANDARD_DEVIATION 5.82 • n=5 Participants
|
55.07 years
STANDARD_DEVIATION 5.03 • n=7 Participants
|
54.73 years
STANDARD_DEVIATION 5.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
58 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=5 Participants
|
57 participants
n=7 Participants
|
115 participants
n=5 Participants
|
|
Colorectal Cancer Screening Knowledge Measure
|
9.03 units on a scale
STANDARD_DEVIATION 2.27 • n=5 Participants
|
9.79 units on a scale
STANDARD_DEVIATION 2.09 • n=7 Participants
|
9.41 units on a scale
STANDARD_DEVIATION 2.21 • n=5 Participants
|
|
Colorectal Cancer Screening Self-Efficacy Scale
|
1.99 units on a scale
STANDARD_DEVIATION 0.54 • n=5 Participants
|
1.92 units on a scale
STANDARD_DEVIATION 0.55 • n=7 Participants
|
1.95 units on a scale
STANDARD_DEVIATION 0.55 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThe 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.
Outcome measures
| Measure |
Community Health Advisor
n=45 Participants
Intervention arm participants will be scheduled to receive the Community Health Advisor intervention within 4 to 6 weeks after enrollment, a Fecal Immunochemical Test kit, a mailed targeted colorectal cancer brochure, and a follow-up telephone survey at 3- and 12-months post-intervention
Community Health Advisor: Intervention arm participants will receive one 45-minute face-to-face meeting followed by two Community Health Advisor phone calls in one-week intervals over a period of three weeks beginning within one month following baseline survey completion. These colorectal cancer educational activities delivered by the Community Health Advisors will include the use of National Cancer Institute colorectal cancer resources and materials, including a Screen to Save media presentation, and colorectal cancer educational 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, 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 colorectal cancer screening.
|
Usual Care
n=48 Participants
Control group 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.
Usual care: 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.
|
|---|---|---|
|
Number of Participants Up to Date on Colorectal Cancer Screening
|
29 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 12 monthsParticipants 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."
Outcome measures
| Measure |
Community Health Advisor
n=45 Participants
Intervention arm participants will be scheduled to receive the Community Health Advisor intervention within 4 to 6 weeks after enrollment, a Fecal Immunochemical Test kit, a mailed targeted colorectal cancer brochure, and a follow-up telephone survey at 3- and 12-months post-intervention
Community Health Advisor: Intervention arm participants will receive one 45-minute face-to-face meeting followed by two Community Health Advisor phone calls in one-week intervals over a period of three weeks beginning within one month following baseline survey completion. These colorectal cancer educational activities delivered by the Community Health Advisors will include the use of National Cancer Institute colorectal cancer resources and materials, including a Screen to Save media presentation, and colorectal cancer educational 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, 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 colorectal cancer screening.
|
Usual Care
n=48 Participants
Control group 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.
Usual care: 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.
|
|---|---|---|
|
Colorectal Cancer Screening Knowledge Measure
|
10.42 score on a scale
Standard Deviation 2.01
|
9.88 score on a scale
Standard Deviation 1.61
|
SECONDARY outcome
Timeframe: 12 monthsA 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."
Outcome measures
| Measure |
Community Health Advisor
n=45 Participants
Intervention arm participants will be scheduled to receive the Community Health Advisor intervention within 4 to 6 weeks after enrollment, a Fecal Immunochemical Test kit, a mailed targeted colorectal cancer brochure, and a follow-up telephone survey at 3- and 12-months post-intervention
Community Health Advisor: Intervention arm participants will receive one 45-minute face-to-face meeting followed by two Community Health Advisor phone calls in one-week intervals over a period of three weeks beginning within one month following baseline survey completion. These colorectal cancer educational activities delivered by the Community Health Advisors will include the use of National Cancer Institute colorectal cancer resources and materials, including a Screen to Save media presentation, and colorectal cancer educational 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, 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 colorectal cancer screening.
|
Usual Care
n=48 Participants
Control group 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.
Usual care: 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.
|
|---|---|---|
|
Colorectal Cancer Screening Self-Efficacy Scale
|
1.86 score on a scale
Standard Deviation 0.56
|
1.98 score on a scale
Standard Deviation 0.61
|
Adverse Events
Community Health Advisor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Tanise Jackson, Director of Animal Welfare Research Integrity
Florida A&M University
Phone: 850-599-3214
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place