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| ID | Type | Description | Link |
|---|---|---|---|
| U54MD007582-34A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Community Health Advisor | Experimental | 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 |
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| Usual care | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Up to Date on 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Colorectal Cancer Screening Knowledge Measure | 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." |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karam Soliman, PhD | Florida A&M University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida A&M University | Tallahassee | Florida | 323207 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40450376 | Derived | Luque JS, Kiros GE, Vargas MA, Ali A, Tawk R, Jackson DR, Dickey SL, Harris CM, Robinson T, Duncan B, Freeman J, Gwede CK, Wallace K. Effectiveness of a community health advisor colorectal cancer screening educational intervention on stool test completion in an African American primary care patient population: a pragmatic randomized controlled trial. BMC Glob Public Health. 2025 Jun 1;3(1):47. doi: 10.1186/s44263-025-00168-4. | |
| 35168640 | Derived |
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Data sharing will be overseen by the Principal Investigator. To facilitate sharing of data, study outcome publications from this colorectal cancer 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 National Institutes of Health (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.
3 years following completion of the project
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:
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Up to Date on 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. | Posted | Count of Participants | Participants | 12 months |
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All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed during the 2 year data collection time period.
Participants only completed surveys in our study and there was no risk for adverse events from our study protocol. There were no "O" participants at risk for adverse events as this was an educational intervention study and adverse events were not monitored or assessed.All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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. |
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The projected sample size was originally 244. Because of difficulties in recruiting this patient population of African American patients in 2 community health centers who were not up to date with colorectal cancer screening, the study was only able to recruit 115 individuals over the 2 year recruitment period. Therefore, there is smaller number of patients to analyze the effectiveness of the educational intervention, and the study is underpowered.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tanise Jackson, Director of Animal Welfare Research Integrity | Florida A&M University | 850-599-3214 | tanise.jackson@famu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 26, 2022 | Jun 11, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 21, 2022 | May 6, 2024 | ICF_001.pdf |
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Participants will be randomly assigned to the TUNE-UP intervention or a control group that will receive educational materials about colorectal cancer screening plus a resource list but no Community Health Advisor counseling support or cellphone / text contact like in the TUNE-UP Community Health Advisor intervention group.
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Participant will complete surveys and receive mailings and not know if they are in control arm or intervention arm.
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| 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. |
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| 12 months |
| 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." | 12 months |
| 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Colorectal Cancer Screening Knowledge Measure | 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." | Mean | Standard Deviation | units on a scale |
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| 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." | Mean | Standard Deviation | units on a scale |
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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.
| OG001 | 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. |
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| Secondary | Colorectal Cancer Screening Knowledge Measure | 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." | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | 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." | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| 0 |
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| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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