Virtual Human Delivered Nutrition Module for Colorectal Cancer Prevention

NCT ID: NCT04192071

Last Updated: 2024-08-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-06

Study Completion Date

2022-11-01

Brief Summary

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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

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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).

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type ACTIVE_COMPARATOR

virtual technology - high interactive

Intervention Type 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.

low interactive virtual human module

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

Group Type ACTIVE_COMPARATOR

virtual technology - low interactive

Intervention Type 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.

attention control module

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

Group Type SHAM_COMPARATOR

non-colorectal cancer related module

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

non-colorectal cancer related module

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

Intervention Type OTHER

Other Intervention Names

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Virtual human nutrition module virtual human standard attention control

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

73 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Melissa Vilaro, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 38390218 (View on PubMed)

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.

Reference Type RESULT
PMID: 36919704 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Pilot test

View Document

Document Type: Informed Consent Form: Think aloud

View Document

Other Identifiers

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3R01CA207689-03S2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OCR27722

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201902537

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201902537

Identifier Type: -

Identifier Source: org_study_id

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