Trial Outcomes & Findings for Virtual Human Delivered Nutrition Module for Colorectal Cancer Prevention (NCT NCT04192071)
NCT ID: NCT04192071
Last Updated: 2024-08-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
139 participants
Primary outcome timeframe
up to 2 hours
Results posted on
2024-08-28
Participant Flow
Aim 2 Pilot Test: Web-based, single-interaction, intervention Aim 2 intervention development (focus groups and interviews)
Total N =139 (Aim 1 = 48; Aim 2 = 91) AIMS 1 \& 2 are independent. Aim 1 participants did NOT complete Aim 2. (AIM 2) Qualtrics panels recruited a national sample of (n=91) rural adults. Respondents from this national sample who did not meet the qualifying criteria were screened out by the Qualtrics platform and did not get randomized to one of the 3 arms of the web-based, intervention. ( AIM 1) participants (n=48) completed focus groups/interviews informing intervention content.
Participant milestones
| Measure |
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
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.
|
Low Interactive Virtual Human Module
Complete the current intervention module that includes items assessing alcohol and meat intake.
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.
|
Attention Control Module
The attention control group, will complete a related module not related to colorectal cancer or nutrition
non-colorectal cancer related module: Participants engage with web-based content not related to colorectal cancer or nutrition.
|
AIM 1 Focus Group and Interview Participants
a total of 48 participants completed focus groups and interviews to provide feedback on iteratively updated versions of the culturally tailored, web-based, intervention, and participate in user testing. These participants did NOT participate in the AIM 2 pilot testing of the 3-arm, randomized trial.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
35
|
25
|
48
|
|
Overall Study
COMPLETED
|
31
|
35
|
25
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Virtual Human Delivered Nutrition Module for Colorectal Cancer Prevention
Baseline characteristics by cohort
| Measure |
Aim 2 Web-based Pilot Test: Control
n=25 Participants
participants interact with attention control information about clinical trials (not focused on cancer, not focused on nutrition)
|
Aim 2 Web-based Pilot Test: Low Interactive Condition
n=35 Participants
Participants interact with nutrition and cancer risk information in a low interactive condition.
|
Aim 2 Web-based Pilot Test: VHA High Interactive Condition
n=31 Participants
Participants interact with nutrition and cancer risk information delivered by a Virtual Health Assistant in a high interactive condition.
|
Aim 1: Focus Group and Interviews
n=48 Participants
Participants provided feedback to inform the web-based intervention that would be pilot-tested in Aim 2.
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
107 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 8 • n=5 Participants
|
55.1 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
57 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
61.7 years
STANDARD_DEVIATION 7 • n=4 Participants
|
56 years
STANDARD_DEVIATION 8.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
85 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
136 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
71 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
35 participants
n=7 Participants
|
31 participants
n=5 Participants
|
48 participants
n=4 Participants
|
91 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: up to 2 hoursItems 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.
Outcome measures
| Measure |
Aim 2 Web-based Pilot Test: Control
n=25 Participants
participants interact with attention control information about clinical trials (not focused on cancer, not focused on nutrition)
|
Aim 2 Web-based Pilot Test: Low Interactive Condition
n=35 Participants
Participants interact with nutrition and cancer risk information in a low interactive condition.
|
Aim 2 Web-based Pilot Test: VHA High Interactive Condition
n=31 Participants
Participants interact with nutrition and cancer risk information delivered by a Virtual Health Assistant in a high interactive condition.
|
|---|---|---|---|
|
Risk Perceptions for Colorectal Cancer
|
3.3 score on a scale
Standard Deviation 1.5
|
3.6 score on a scale
Standard Deviation 1.4
|
3.5 score on a scale
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: up to 2 hoursTwo 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).
Outcome measures
| Measure |
Aim 2 Web-based Pilot Test: Control
n=25 Participants
participants interact with attention control information about clinical trials (not focused on cancer, not focused on nutrition)
|
Aim 2 Web-based Pilot Test: Low Interactive Condition
n=35 Participants
Participants interact with nutrition and cancer risk information in a low interactive condition.
|
Aim 2 Web-based Pilot Test: VHA High Interactive Condition
n=31 Participants
Participants interact with nutrition and cancer risk information delivered by a Virtual Health Assistant in a high interactive condition.
|
|---|---|---|---|
|
Intentions to Screen for Colorectal Cancer
4 point, 6-month readiness
|
2.6 score on a scale
Standard Deviation 1
|
2.5 score on a scale
Standard Deviation 1
|
2.5 score on a scale
Standard Deviation .8
|
|
Intentions to Screen for Colorectal Cancer
7-point Likert Intention
|
5 score on a scale
Standard Deviation 1.6
|
4.9 score on a scale
Standard Deviation 2.0
|
5.2 score on a scale
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: up to 2 hoursDoes participant click on link to more information. The survey platforms event tracking feature will be used to track clicks (yes/no) for more information.
Outcome measures
| Measure |
Aim 2 Web-based Pilot Test: Control
n=25 Participants
participants interact with attention control information about clinical trials (not focused on cancer, not focused on nutrition)
|
Aim 2 Web-based Pilot Test: Low Interactive Condition
n=35 Participants
Participants interact with nutrition and cancer risk information in a low interactive condition.
|
Aim 2 Web-based Pilot Test: VHA High Interactive Condition
n=31 Participants
Participants interact with nutrition and cancer risk information delivered by a Virtual Health Assistant in a high interactive condition.
|
|---|---|---|---|
|
Information Seeking Behavior
No
|
11 Participants
|
14 Participants
|
14 Participants
|
|
Information Seeking Behavior
Yes
|
14 Participants
|
21 Participants
|
17 Participants
|
Adverse Events
Aim 2 Web-based Pilot Test: Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aim 2 Web-based Pilot Test: Low Interactive Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aim 2 Web-based Pilot Test: VHA High Interactive Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aim 1 Focus Groups and Interviews
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Melissa Vilaro, Assistant Professor
University of Florida
Phone: 352-2733525
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place