Colorectal CancerNCT04192071
Virtual Human Delivered Nutrition Module for Colorectal Cancer Prevention
A study testing virtual technology - high interactive, virtual technology - low interactive and non-colorectal cancer related module in people with Colorectal Cancer, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 73 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- virtual technology - high interactive, virtual technology - low interactive and non-colorectal cancer related module
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 73 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adapting and Pilot Testing a Nutrition Module Delivered With Virtual Human Technology 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.
Read the detailed description
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
- Colorectal Cancer
- Being tested
- virtual technology - high interactive, virtual technology - low interactive, non-colorectal cancer related module
- Keywords
- Nutrition
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual technology - high interactiveOther
Also called Virtual human nutrition module
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.
virtual technology - low interactiveOther
Also called virtual human standard
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.
non-colorectal cancer related moduleOther
Also called attention control
Participants engage with web-based content not related to colorectal cancer or nutrition.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 Receives: Other: non-colorectal cancer related module |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2 hours
Intentions to Screen for Colorectal Cancer
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).
Measured: 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.
Measured: up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start6 Jan 2020
- Primary completion27 Jun 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Melissa Vilaro, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192071
- Sponsor's protocol ID
- IRB201902537
- Other IDs
- 3R01CA207689-03S2, OCR27722, IRB201902537
- Status last verified
- Aug 2024
- First submitted
- 6 Dec 2019
- Last updated
- 28 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38390218Vilaro 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.
PubMed 36919704
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting and Pilot Testing a Nutrition Module Delivered With Virtual Human Technology for Colorectal Cancer Prevention
- ClinicalTrials.gov ID
- NCT04192071
- Acronym / sponsor ID
- IRB201902537
- Conditions
- Colorectal Cancer
- Keywords
- Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 27 Jun 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Posted 28 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| high interactive virtual human administered nutrition module | Active comparator | Other: virtual technology - high interactiveThe 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 |
| low interactive virtual human module | Active comparator | Other: virtual technology - low interactiveComplete the current intervention module that includes items assessing alcohol and meat intake. |
| attention control module | Sham comparator | Other: non-colorectal cancer related moduleThe attention control group, will complete a related module not related to colorectal cancer or nutrition |
Who may qualify
- Ages
- 45 to 73 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual technology - high interactiveAlso: Virtual human nutrition moduleParticipants 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 | high interactive virtual human administered nutrition module |
| virtual technology - low interactiveAlso: virtual human standardParticipants 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 | low interactive virtual human module |
| non-colorectal cancer related moduleAlso: attention controlParticipants engage with web-based content not related to colorectal cancer or nutrition. | Other | attention control module |
Primary outcome
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.
Intentions to Screen for Colorectal Cancer
Time frame: up to 2 hours
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).
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 38390218Vilaro 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.
- Results publication: PubMed 36919704Vilaro 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.
- Individual participant dataSharing planned: No
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Vilaro, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual technology - high interactive, virtual technology - low interactive and non-colorectal cancer related module in people with Colorectal Cancer, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk Perceptions for Colorectal Cancer (time frame: up to 2 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04192071, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.