Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Virtual Human Delivered Nutrition Module for Colorectal Cancer Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04192071
Recruitment Status : Recruiting
First Posted : December 10, 2019
Last Update Posted : February 12, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Florida

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study uses the opinions of adults between the ages of 50 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. This study will contribute to knowledge of what messages and graphics promote understanding of cancer risk and promote screening.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Other: virtual technology - high interactive Other: virtual technology - low interactive Other: non-colorectal cancer related module Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: Adapting and Pilot Testing a Nutrition Module Delivered With Virtual Human Technology for Colorectal Cancer Prevention
Actual Study Start Date : January 6, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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 Name: 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 Name: attention control


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Risk perceptions for colorectal cancer [ Time Frame: up to 2 hours ]
    Items measured on a 10-point Likert scale, (e.g. "My chances of getting colorectal cancer are high")

  2. Intentions to screen for colorectal cancer [ Time Frame: up to 2 hours ]
    Items measured on a 10-point Likert scale, (e.g. "I want to get screened for colorectal cancer")

  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 73 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Eligible adults will be between 50-73 years old,
  • Proficient in English and
  • Geographically residing rural areas of north central Florida.

Exclusion Criteria:

-

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04192071


Contacts
Layout table for location contacts
Contact: Melissa Vilaro, PhD 352-846-3014 mgraveley@ufl.edu

Locations
Layout table for location information
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Melissa Vilaro, PhD         
Principal Investigator: Melissa Vilaro, PhD         
Sponsors and Collaborators
University of Florida
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Melissa Vilaro, PhD University of Florida
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04192071    
Other Study ID Numbers: IRB201902537-N
3R01CA207689-03S2 ( U.S. NIH Grant/Contract )
OCR27722 ( Other Identifier: UF OnCore )
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: February 12, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
Nutrition
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases