Back to results

Virtual Human Delivered Nutrition Module for Colorectal Cancer Prevention

Primary Purpose

Colorectal Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

virtual technology - high interactive

virtual technology - low interactive

non-colorectal cancer related module

About this trial

This is an interventional screening trial for Colorectal Cancer focused on measuring Nutrition

Eligibility Criteria

45 Years - 73 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

Sites / Locations

University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Arm Label

high interactive virtual human administered nutrition module

low interactive virtual human module

attention control module

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Risk perceptions for colorectal cancer

Items measured on a 10-point Likert scale, (e.g. "My chances of getting colorectal cancer are high")

Intentions to screen for colorectal cancer

Items measured on a 10-point Likert scale, (e.g. "I want to get screened for colorectal cancer")

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04192071

First Posted

December 6, 2019

Last Updated

September 12, 2023

Sponsor

University of Florida

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT04192071

Brief Title

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

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 6, 2020 (Actual)

Primary Completion Date

January 31, 2024 (Anticipated)

Study Completion Date

January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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. This study will contribute to knowledge of what messages and graphics promote understanding of cancer risk and promote screening.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

Nutrition

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

high interactive virtual human administered nutrition module

Arm Type

Active Comparator

Arm Description

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

Arm Title

low interactive virtual human module

Arm Type

Active Comparator

Arm Description

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

Arm Title

attention control module

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

virtual technology - high interactive

Other Intervention Name(s)

Virtual human nutrition module

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

virtual technology - low interactive

Other Intervention Name(s)

virtual human standard

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

non-colorectal cancer related module

Other Intervention Name(s)

attention control

Intervention Description

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

Primary Outcome Measure Information:

Title

Risk perceptions for colorectal cancer

Description

Items measured on a 10-point Likert scale, (e.g. "My chances of getting colorectal cancer are high")

Time Frame

up to 2 hours

Title

Intentions to screen for colorectal cancer

Description

Items measured on a 10-point Likert scale, (e.g. "I want to get screened for colorectal cancer")

Time Frame

up to 2 hours

Title

Information seeking behavior

Description

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.

Time Frame

up to 2 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

73 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Eligible adults will be between 45 -73 years old, Proficient in English and Geographically residing in rural areas. Exclusion: -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Melissa Vilaro, PhD

Phone

352-273-3525

mgraveley@ufl.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Melissa Vilaro, PhD

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32611

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Melissa Vilaro, PhD

First Name & Middle Initial & Last Name & Degree

Melissa Vilaro, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Virtual Human Delivered Nutrition Module for Colorectal Cancer Prevention

We'll reach out to this number within 24 hrs