Clinical trial NCT04192071: Virtual Human Delivered Nutrition Module for Colorectal Cancer Prevention
Official title: Adapting and Pilot Testing a Nutrition Module Delivered With Virtual Human Technology for Colorectal Cancer Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Nutrition
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-12-10
Enrollment: 139
Sex: ALL
Minimum age (years): 45
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Risk Perceptions for Colorectal Cancer
timeFrame: up to 2 hours
measure: Intentions to Screen for Colorectal Cancer
timeFrame: up to 2 hours
measure: Information Seeking Behavior
timeFrame: up to 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Melissa Vilaro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.