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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA207689-01A1 | U.S. NIH Grant/Contract | View source | |
| OCR17004 | Other Identifier | UF OnCore |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of this proposal is to test the efficacy of a patient-centered, tailored message intervention delivered via virtual technology for increasing colorectal cancer (CRC) screening within guidelines among racial/ethnic minority and rural patients. This protocol focuses on the clinical portion of grant NCI 1RCA207689-01A1
Patients will be recruited via a secure, clinical data warehouse to complete a patient-randomized test of the efficacy of the intervention for promoting initial and repeat FIT testing. Patients identified as eligible will be contacted through MyChart to test a web-based, culturally-sensitive virtual human intervention for CRC screening. The web-application will provide information to encourage CRC screening. Therefore, this study is a minimal risk study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Human (VH) | Experimental | Patients were randomly assigned to a virtual human (VH) screening condition after completing the eligibility for CRC requirements. |
|
| Text-Base (TB) | Experimental | Patients were randomly assigned to a text-based (TB) screening condition after completing the eligibility for CRC requirements. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| virtual technology | Other | The app will first ask participants a short series of questions designed to assess their baseline risk for colon cancer. Highly tailored patient reminders will be customized using all 12 constructs. |
| Measure | Description | Time Frame |
|---|---|---|
| Intention to Screen for Colorectal Cancer (CRC) | Measure: Intention to Screen for Colorectal Cancer Item: I want to get screened for colorectal cancer. Scale: 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Mean scores near 1 indicate a lower intention to get screened for colorectal cancer. Mean scores near 5 indicate a higher intention to get screened for colorectal cancer. Construct: Behavioral intention to screen No subscales | within the first 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Communication With a Provider About Colorectal Cancer (CRC) | Measure: Intention to talk to doctor about colorectal cancer screening. Construct: Behavioral intention to communicate Item: I will talk to my healthcare provider about colorectal cancer screening. Scale: 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Mean scores near 1 indicate a lower intention to talk to a healthcare professional about colorectal cancer screening. Mean scores near 5 indicate a high intention to talk to a healthcare professional about colorectal cancer screening. No subscales |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Lok | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States | ||
| University of Florida |
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| ID | Title | Description |
|---|---|---|
| FG000 | Virtual Human (VH) Screening | Patients were randomly assigned to a virtual human (VH) screening condition after completing the eligibility for CRC requirements. virtual technology - highly tailored VH: The app will first ask participants a short series of questions designed to assess their baseline risk for colon cancer. Highly tailored patient reminders will be customized using all 12 constructs. The VH-tailored content was presented using an animated computer-generated character to deliver tailored, culturally aligned health messages about CRC screening. |
| FG001 | Text-Based (TB) Screening | Patients were randomly assigned to a text-based (TB) screening condition after completing the eligibility for CRC requirements. virtual technology - tailored minimally TB: The app will first ask participants a short series of questions designed to assess their baseline risk for colon cancer. Minimally tailored patient reminders will be customized using 4 randomly selected constructs. The TB-tailored content was presented using an image of a computer-generated character to deliver tailored, culturally aligned health messages about CRC screening. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Although 482 participants were initially enrolled in the Virtual Human (VH) Screening arm and 478 in the Text-Based (TB) Screening arm, only those who completed the baseline assessment were included in the analysis. Specifically, 473 VH participants and 470 TB participants completed the baseline, while 9 and 8 participants, respectively, did not complete it. These 17 individuals were excluded from the analysis due to incomplete baseline data.
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| ID | Title | Description |
|---|---|---|
| BG000 | Virtual Human (VH) Screening | Patients were randomly assigned to a virtual human (VH) screening condition after completing the eligibility for CRC requirements. virtual technology - highly tailored VH: The app will first ask participants a short series of questions designed to assess their baseline risk for colon cancer. Highly tailored patient reminders will be customized using all 12 constructs. The VH-tailored content was presented using an animated computer-generated character to deliver tailored, culturally aligned health messages about CRC screening. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Although 482 participants were initially enrolled in the Virtual Human (VH) Screening arm and 478 in the Text-Based (TB) Screening arm, only those who completed the baseline assessment were included in the analysis. Specifically, 473 VH participants and 470 TB participants completed the baseline, while 9 and 8 participants, respectively, did not complete it. These 17 individuals were excluded from the analysis due to incomplete baseline data. |
| 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 | Intention to Screen for Colorectal Cancer (CRC) | Measure: Intention to Screen for Colorectal Cancer Item: I want to get screened for colorectal cancer. Scale: 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Mean scores near 1 indicate a lower intention to get screened for colorectal cancer. Mean scores near 5 indicate a higher intention to get screened for colorectal cancer. Construct: Behavioral intention to screen No subscales | Posted | Mean | Standard Deviation | units on a scale | within the first 12 months |
|
Adverse event data were collected for 5 years and 2 months.
During the study, 943 participants were monitored/assessed for other (non-serious) adverse events, but none were observed. We followed a non-systematic method, such as participants' self-reports, to identify whether or not adverse events occurred.
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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 | Virtual Human (VH) Screening | Patients were randomly assigned to a virtual human (VH) screening condition after completing the eligibility for CRC requirements. virtual technology - highly tailored VH: The app will first ask participants a short series of questions designed to assess their baseline risk for colon cancer. Highly tailored patient reminders will be customized using all 12 constructs. The VH-tailored content was presented using an animated computer-generated character to deliver tailored, culturally aligned health messages about CRC screening. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Benjamin Lok | University of Florida | 352-214-9829 | lok@ufl.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 | Nov 17, 2023 | Mar 10, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 30, 2023 | Jun 4, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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Study Team will recruit an ethnically diverse sample of eligible patients to complete the intervention.
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| Assessed after 24 months |
| Jacksonville |
| Florida |
| 32208 |
| United States |
| BG001 | Text-Based (TB) Screening | Patients were randomly assigned to a text-based (TB) screening condition after completing the eligibility for CRC requirements. virtual technology - tailored minimally TB: The app will first ask participants a short series of questions designed to assess their baseline risk for colon cancer. Minimally tailored patient reminders will be customized using 4 randomly selected constructs. The TB-tailored content was presented using an image of a computer-generated character to deliver tailored, culturally aligned health messages about CRC screening. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex/Gender, Customized | The study did not require participants to self-report their sex. There is no sex data for 40 participants. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Text-Base (TB) | Patients were randomly assigned to a text-based (TB) screening condition after completing the eligibility for CRC requirements. virtual technology: The app will first ask participants a short series of questions designed to assess their baseline risk for colon cancer. Highly tailored patient reminders will be customized using all 12 constructs. |
|
|
| Secondary | Communication With a Provider About Colorectal Cancer (CRC) | Measure: Intention to talk to doctor about colorectal cancer screening. Construct: Behavioral intention to communicate Item: I will talk to my healthcare provider about colorectal cancer screening. Scale: 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Mean scores near 1 indicate a lower intention to talk to a healthcare professional about colorectal cancer screening. Mean scores near 5 indicate a high intention to talk to a healthcare professional about colorectal cancer screening. No subscales | Posted | Mean | Standard Deviation | units on a scale | Assessed after 24 months |
|
|
|
| 0 |
| 473 |
| 0 |
| 473 |
| 0 |
| 473 |
| EG001 | Text-Based (TB) Screening | Patients were randomly assigned to a text-based (TB) screening condition after completing the eligibility for CRC requirements. virtual technology - tailored minimally TB: The app will first ask participants a short series of questions designed to assess their baseline risk for colon cancer. Minimally tailored patient reminders will be customized using 4 randomly selected constructs. The TB-tailored content was presented using an image of a computer-generated character to deliver tailored, culturally aligned health messages about CRC screening. | 0 | 470 | 0 | 470 | 0 | 470 |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |