Virtual Human Delivered Nutrition Module for Colorectal Cancer Prevention

Adapting and Pilot Testing a Nutrition Module Delivered With Virtual Human Technology for Colorectal Cancer Prevention

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:

• What content do adults want to receive from a web-based interaction about colorectal cancer screening and nutritional risks for colorectal cancer?
• Does a brief interaction with a virtual human delivering tailored cancer prevention information impact cancer prevention intentions and attitudes among a national sample of geographically rural U.S. adults?

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: virtual technology - high interactive; Other: virtual technology - low interactive; Other: non-colorectal cancer related module

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 139
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Eligible adults will be between 45 -73 years old,
• Proficient in English and
• Geographically residing in rural areas (based on zip code)
• Identify as Black or White racial identity

Exclusion:

• Completed a colonoscopy in the past 10 years
• Completed a sigmoidoscopy in the past 5 years
• Completed a home stool test in the past 12 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Other: 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.; Other Names: Virtual human nutrition module
Active Comparator: low interactive virtual human module; Complete the current intervention module that includes items assessing alcohol and meat intake.	Other: 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.; Other Names: virtual human standard
Sham Comparator: attention control module; The attention control group, will complete a related module not related to colorectal cancer or nutrition	Other: non-colorectal cancer related module; Participants engage with web-based content not related to colorectal cancer or nutrition.; Other Names: attention control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: A single item measured intentions to screen for colorectal cancer (readiness to screen) adapted from (Boonyasiriwat, Hung, Hon, et. al, 2014.) Participants answer the following prompt: "Please indicate what best represents your plans for colorectal cancer screening". Response options str: 1 point = I am not planning to screen in the next 6 months; 2 points = I am thinking about screen, but not in the next 6 months; 3 points = I am considering screening in the next 6 months and 4 points for = I am already taking steps to screen in the next 6 months. Higher scores =higher readiness to screen (better outcome). Min. score = 1 ; Max. score =4.; a single item assessed intentions on a Likert Scale. Question: "I want to get screened for colorectal cancer" where: 1 = strongly disagree-7 = strongly agree). Min. score = 1 - Max. score is 7. Higher scores indicate a stronger desire to obtain screening (better outcome).	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

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Melissa Vilaro, PhD, University of Florida

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Actual): June 27, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: December 6, 2019
• First Submitted That Met QC Criteria: December 6, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Nutrition
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: IRB201902537 (Other Identifier: IRB); 3R01CA207689-03S2 (U.S. NIH Grant/Contract); OCR27722 (Other Identifier: UF OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No