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| ID | Type | Description | Link |
|---|---|---|---|
| 3R01CA207689-03S2 | U.S. NIH Grant/Contract | View source | |
| OCR27722 | Other Identifier | UF OnCore | |
| IRB201902537 | Other Identifier | IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This study uses the opinions of adults between the ages of 45 and 73 years old to develop and test an interactive nutrition module for use in an existing colorectal cancer screening intervention using virtual human technology. The main questions answered include:
This study will contribute to knowledge of what messages and graphics promote understanding of cancer risk and promote screening with the potential to promote behaviors that reduce cancer risk.
The study occurred in two phases. Phase one was a qualitative aim that collected feedback from participants in iterative cycles of focus groups and individual think-aloud interviews. Phase one feedback was analyzed and applied to develop a tailored, web-based prototype that addressed participant desires for an intervention to address colorectal cancer prevention and nutrition risk education. The prototype was a brief conversation delivered by an interactive Virtual Health Assistant (virtual character with audio and visual elements that mimic a conversation with a human).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high interactive virtual human administered nutrition module | Active Comparator | The virtual health assistant will interactively collect nutrition information (alcohol, red meat, and processed meat intake) and report risk information back to users in visual and audio format |
|
| low interactive virtual human module | Active Comparator | Complete the current intervention module that includes items assessing alcohol and meat intake. |
|
| attention control module | Sham Comparator | The attention control group, will complete a related module not related to colorectal cancer or nutrition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| virtual technology - high interactive | Other | Participants engage with web-based cancer prevention content and answer a short series of questions designed to assess their baseline risk for colon cancer and dietary intake. Interactive nutrition risk feedback will be customized based on user input. |
| Measure | Description | Time Frame |
|---|---|---|
| Risk Perceptions for Colorectal Cancer | Items measured on a 7-point Likert scale, (e.g. "My chances of getting colorectal cancer are high"), where 1 is strongly disagree and 7 is strongly agree. | up to 2 hours |
| Intentions to Screen for Colorectal Cancer | Two individual items assessed intentions to screen:
| up to 2 hours |
| Information Seeking Behavior | Does participant click on link to more information. The survey platforms event tracking feature will be used to track clicks (yes/no) for more information. | up to 2 hours |
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Inclusion Criteria:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Vilaro, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38390218 | Background | Vilaro MJ, Bryan E, Palani T, Cooks EJ, Mertens G, Zalake M, Lok BC, Krieger JL. Rural adults' perceptions of nutrition recommendations for cancer prevention: Contradictory and conflicting messages. Prev Oncol Epidemiol. 2023;1(1):2237680. doi: 10.1080/28322134.2023.2237680. Epub 2023 Nov 17. | |
| 36919704 | Result | Vilaro MJ, McAlindon K, Mertens G, Ashley T, Zalake M, Cooks EJ, Krieger JL. Information Architects: Using Community-Engaged and Qualitative Methods to Design a Technology-Based Nutrition and Cancer Risk Intervention for Rural Adults. Cancer Control. 2023 Jan-Dec;30:10732748221130162. doi: 10.1177/10732748221130162. |
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Total N =139 (Aim 1 = 48; Aim 2 = 91)
AIMS 1 & 2 are independent. Aim 1 participants did NOT complete Aim 2.
(AIM 2) Qualtrics panels recruited a national sample of (n=91) rural adults. Respondents from this national sample who did not meet the qualifying criteria were screened out by the Qualtrics platform and did not get randomized to one of the 3 arms of the web-based, intervention.
( AIM 1) participants (n=48) completed focus groups/interviews informing intervention content.
Aim 2 Pilot Test: Web-based, single-interaction, intervention Aim 2 intervention development (focus groups and interviews)
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| ID | Title | Description |
|---|---|---|
| FG000 | High Interactive Virtual Human Administered Nutrition Module | The virtual health assistant will interactively collect nutrition information (alcohol, red meat, and processed meat intake) and report risk information back to users in visual and audio format virtual technology - high interactive: Participants engage with web-based cancer prevention content and answer a short series of questions designed to assess their baseline risk for colon cancer and dietary intake. Interactive nutrition risk feedback will be customized based on user input. |
| FG001 | Low Interactive Virtual Human Module | Complete the current intervention module that includes items assessing alcohol and meat intake. virtual technology - low interactive: Participants engage with web-based cancer prevention content and answer a short series of questions designed to assess their baseline risk for colon cancer. Minimally interactive risk feedback will be delivered. |
| FG002 | Attention Control Module | The attention control group, will complete a related module not related to colorectal cancer or nutrition non-colorectal cancer related module: Participants engage with web-based content not related to colorectal cancer or nutrition. |
| FG003 | AIM 1 Focus Group and Interview Participants | a total of 48 participants completed focus groups and interviews to provide feedback on iteratively updated versions of the culturally tailored, web-based, intervention, and participate in user testing. These participants did NOT participate in the AIM 2 pilot testing of the 3-arm, randomized trial. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aim 2 Web-based Pilot Test: Control | participants interact with attention control information about clinical trials (not focused on cancer, not focused on nutrition) |
| BG001 | Aim 2 Web-based Pilot Test: Low Interactive Condition |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Risk Perceptions for Colorectal Cancer | Items measured on a 7-point Likert scale, (e.g. "My chances of getting colorectal cancer are high"), where 1 is strongly disagree and 7 is strongly agree. | Posted | Mean | Standard Deviation | score on a scale | up to 2 hours |
|
We did not monitor adverse events as the potential risks were not more than would be expected in every day life. There are no potential risks of physical, psychological or economic harm associated with participating in this study.
Participants engaged in focus groups, interviews and remote completion of a one-time, web-based educational interaction, thus we did not collect adverse events.
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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 | Aim 2 Web-based Pilot Test: Control | participants interact with attention control information about clinical trials (not focused on cancer, not focused on nutrition) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Vilaro, Assistant Professor | University of Florida | 352-2733525 | mgraveley@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 | May 24, 2022 | Mar 20, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Pilot test | Feb 15, 2022 | Mar 19, 2024 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Think aloud | Oct 5, 2020 | Mar 19, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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|
|
| virtual technology - low interactive | Other | Participants engage with web-based cancer prevention content and answer a short series of questions designed to assess their baseline risk for colon cancer. Minimally interactive risk feedback will be delivered. |
|
|
| non-colorectal cancer related module | Other | Participants engage with web-based content not related to colorectal cancer or nutrition. |
|
|
Participants interact with nutrition and cancer risk information in a low interactive condition.
| BG002 | Aim 2 Web-based Pilot Test: VHA High Interactive Condition | Participants interact with nutrition and cancer risk information delivered by a Virtual Health Assistant in a high interactive condition. |
| BG003 | Aim 1: Focus Group and Interviews | Participants provided feedback to inform the web-based intervention that would be pilot-tested in Aim 2. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG002 |
| Aim 2 Web-based Pilot Test: VHA High Interactive Condition |
Participants interact with nutrition and cancer risk information delivered by a Virtual Health Assistant in a high interactive condition. |
|
|
| Primary | Intentions to Screen for Colorectal Cancer | Two individual items assessed intentions to screen:
| Posted | Mean | Standard Deviation | score on a scale | up to 2 hours |
|
|
|
| Primary | Information Seeking Behavior | Does participant click on link to more information. The survey platforms event tracking feature will be used to track clicks (yes/no) for more information. | Posted | Count of Participants | Participants | up to 2 hours |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Aim 2 Web-based Pilot Test: Low Interactive Condition | Participants interact with nutrition and cancer risk information in a low interactive condition. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Aim 2 Web-based Pilot Test: VHA High Interactive Condition | Participants interact with nutrition and cancer risk information delivered by a Virtual Health Assistant in a high interactive condition. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Aim 1 Focus Groups and Interviews | Participants provided feedback to inform the iterative development of web-based colorectal cancer and nutrition risk interaction with a virtual health assistant. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
|