Virtual Human Delivered Nutrition Module for Colorectal Cancer Prevention

NCT04192071 | Completed Results

• 3 other identifiers: IRB2019025373R01CA207689-03S2OCR27722
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Nutrition

Outcome Measures

Primary Outcomes (3)

• 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: 1. 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. 2. 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

Study Arms (3)

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

Other: virtual technology - high interactive

low interactive virtual human module

ACTIVE COMPARATOR

Complete the current intervention module that includes items assessing alcohol and meat intake.

Other: virtual technology - low interactive

attention control module

SHAM COMPARATOR

The attention control group, will complete a related module not related to colorectal cancer or nutrition

Other: non-colorectal cancer related module

Interventions

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.

Also known as: Virtual human nutrition module

high interactive virtual human administered 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.

Also known as: virtual human standard

low interactive virtual human module

non-colorectal cancer related module OTHER

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

Also known as: attention control

attention control module

Eligibility Criteria

• Age: 45 Years - 73 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

Related Publications (2)

• 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.

  PMID: 38390218 BACKGROUND

• 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.

  PMID: 36919704 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Melissa Vilaro, Assistant Professor
• Organization: University of Florida

mgraveley@ufl.edu

352-2733525

Study Officials

• Melissa Vilaro, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 10, 2019
• Study Start: January 6, 2020
• Primary Completion: June 27, 2022
• Study Completion: November 1, 2022
• Last Updated: August 28, 2024
• Results First Posted: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)