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Completed

NCT Number: NCT04192071

Virtual Human Delivered Nutrition Module 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.

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Key information

Age range

45 year–73 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32611, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Virtual human nutrition module

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.

Other names: virtual human standard

non-colorectal cancer related module

Other

Participants engage with web-based content not related to colorectal cancer or nutrition.

Other names: attention control

Primary outcomes

  1. Risk Perceptions for Colorectal Cancer

    Time frame: up to 2 hours

    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.

  2. Intentions to Screen for Colorectal Cancer

    Time frame: up to 2 hours

    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).
  3. Information Seeking Behavior

    Time frame: up to 2 hours

    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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 10, 2019
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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