Trial Outcomes & Findings for A Patient-centered Intervention Using Technology to Reduce Colorectal Cancer Disparities in Primary Care (NCT NCT03407417)

Last Updated: 2025-05-06

Results Overview

Measure: Intention to Screen for Colorectal Cancer Item: I want to get screened for colorectal cancer. Scale: 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Mean scores near 1 indicate a lower intention to get screened for colorectal cancer. Mean scores near 5 indicate a higher intention to get screened for colorectal cancer. Construct: Behavioral intention to screen No subscales

Recruitment status

COMPLETED

Study phase

Target enrollment

960 participants

Primary outcome timeframe

within the first 12 months

Results posted on

2025-05-06

Participant Flow

Participant milestones

Participant milestones
Measure	Virtual Human (VH) Screening Patients were randomly assigned to a virtual human (VH) screening condition after completing the eligibility for CRC requirements. virtual technology - highly tailored VH: The app will first ask participants a short series of questions designed to assess their baseline risk for colon cancer. Highly tailored patient reminders will be customized using all 12 constructs. The VH-tailored content was presented using an animated computer-generated character to deliver tailored, culturally aligned health messages about CRC screening.	Text-Based (TB) Screening Patients were randomly assigned to a text-based (TB) screening condition after completing the eligibility for CRC requirements. virtual technology - tailored minimally TB: The app will first ask participants a short series of questions designed to assess their baseline risk for colon cancer. Minimally tailored patient reminders will be customized using 4 randomly selected constructs. The TB-tailored content was presented using an image of a computer-generated character to deliver tailored, culturally aligned health messages about CRC screening.
Overall Study STARTED	482	478
Overall Study COMPLETED	473	470
Overall Study NOT COMPLETED	9	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Although 482 participants were initially enrolled in the Virtual Human (VH) Screening arm and 478 in the Text-Based (TB) Screening arm, only those who completed the baseline assessment were included in the analysis. Specifically, 473 VH participants and 470 TB participants completed the baseline, while 9 and 8 participants, respectively, did not complete it. These 17 individuals were excluded from the analysis due to incomplete baseline data.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Virtual Human (VH) Screening n=473 Participants Patients were randomly assigned to a virtual human (VH) screening condition after completing the eligibility for CRC requirements. virtual technology - highly tailored VH: The app will first ask participants a short series of questions designed to assess their baseline risk for colon cancer. Highly tailored patient reminders will be customized using all 12 constructs. The VH-tailored content was presented using an animated computer-generated character to deliver tailored, culturally aligned health messages about CRC screening.	Text-Based (TB) Screening n=470 Participants Patients were randomly assigned to a text-based (TB) screening condition after completing the eligibility for CRC requirements. virtual technology - tailored minimally TB: The app will first ask participants a short series of questions designed to assess their baseline risk for colon cancer. Minimally tailored patient reminders will be customized using 4 randomly selected constructs. The TB-tailored content was presented using an image of a computer-generated character to deliver tailored, culturally aligned health messages about CRC screening.	Total n=943 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants • Although 482 participants were initially enrolled in the Virtual Human (VH) Screening arm and 478 in the Text-Based (TB) Screening arm, only those who completed the baseline assessment were included in the analysis. Specifically, 473 VH participants and 470 TB participants completed the baseline, while 9 and 8 participants, respectively, did not complete it. These 17 individuals were excluded from the analysis due to incomplete baseline data.	0 Participants n=7 Participants • Although 482 participants were initially enrolled in the Virtual Human (VH) Screening arm and 478 in the Text-Based (TB) Screening arm, only those who completed the baseline assessment were included in the analysis. Specifically, 473 VH participants and 470 TB participants completed the baseline, while 9 and 8 participants, respectively, did not complete it. These 17 individuals were excluded from the analysis due to incomplete baseline data.	0 Participants n=5 Participants • Although 482 participants were initially enrolled in the Virtual Human (VH) Screening arm and 478 in the Text-Based (TB) Screening arm, only those who completed the baseline assessment were included in the analysis. Specifically, 473 VH participants and 470 TB participants completed the baseline, while 9 and 8 participants, respectively, did not complete it. These 17 individuals were excluded from the analysis due to incomplete baseline data.
Age, Categorical Between 18 and 65 years	381 Participants n=5 Participants • Although 482 participants were initially enrolled in the Virtual Human (VH) Screening arm and 478 in the Text-Based (TB) Screening arm, only those who completed the baseline assessment were included in the analysis. Specifically, 473 VH participants and 470 TB participants completed the baseline, while 9 and 8 participants, respectively, did not complete it. These 17 individuals were excluded from the analysis due to incomplete baseline data.	359 Participants n=7 Participants • Although 482 participants were initially enrolled in the Virtual Human (VH) Screening arm and 478 in the Text-Based (TB) Screening arm, only those who completed the baseline assessment were included in the analysis. Specifically, 473 VH participants and 470 TB participants completed the baseline, while 9 and 8 participants, respectively, did not complete it. These 17 individuals were excluded from the analysis due to incomplete baseline data.	740 Participants n=5 Participants • Although 482 participants were initially enrolled in the Virtual Human (VH) Screening arm and 478 in the Text-Based (TB) Screening arm, only those who completed the baseline assessment were included in the analysis. Specifically, 473 VH participants and 470 TB participants completed the baseline, while 9 and 8 participants, respectively, did not complete it. These 17 individuals were excluded from the analysis due to incomplete baseline data.
Age, Categorical >=65 years	92 Participants n=5 Participants • Although 482 participants were initially enrolled in the Virtual Human (VH) Screening arm and 478 in the Text-Based (TB) Screening arm, only those who completed the baseline assessment were included in the analysis. Specifically, 473 VH participants and 470 TB participants completed the baseline, while 9 and 8 participants, respectively, did not complete it. These 17 individuals were excluded from the analysis due to incomplete baseline data.	111 Participants n=7 Participants • Although 482 participants were initially enrolled in the Virtual Human (VH) Screening arm and 478 in the Text-Based (TB) Screening arm, only those who completed the baseline assessment were included in the analysis. Specifically, 473 VH participants and 470 TB participants completed the baseline, while 9 and 8 participants, respectively, did not complete it. These 17 individuals were excluded from the analysis due to incomplete baseline data.	203 Participants n=5 Participants • Although 482 participants were initially enrolled in the Virtual Human (VH) Screening arm and 478 in the Text-Based (TB) Screening arm, only those who completed the baseline assessment were included in the analysis. Specifically, 473 VH participants and 470 TB participants completed the baseline, while 9 and 8 participants, respectively, did not complete it. These 17 individuals were excluded from the analysis due to incomplete baseline data.
Sex/Gender, Customized Male	135 Participants n=5 Participants • The study did not require participants to self-report their sex. There is no sex data for 40 participants.	142 Participants n=7 Participants • The study did not require participants to self-report their sex. There is no sex data for 40 participants.	277 Participants n=5 Participants • The study did not require participants to self-report their sex. There is no sex data for 40 participants.
Sex/Gender, Customized Female	324 Participants n=5 Participants • The study did not require participants to self-report their sex. There is no sex data for 40 participants.	302 Participants n=7 Participants • The study did not require participants to self-report their sex. There is no sex data for 40 participants.	626 Participants n=5 Participants • The study did not require participants to self-report their sex. There is no sex data for 40 participants.
Sex/Gender, Customized Sex not reported	14 Participants n=5 Participants • The study did not require participants to self-report their sex. There is no sex data for 40 participants.	26 Participants n=7 Participants • The study did not require participants to self-report their sex. There is no sex data for 40 participants.	40 Participants n=5 Participants • The study did not require participants to self-report their sex. There is no sex data for 40 participants.
Ethnicity (NIH/OMB) Hispanic or Latino	27 Participants n=5 Participants	26 Participants n=7 Participants	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	425 Participants n=5 Participants	411 Participants n=7 Participants	836 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	21 Participants n=5 Participants	33 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Black or African American	196 Participants n=5 Participants	205 Participants n=7 Participants	401 Participants n=5 Participants
Race (NIH/OMB) White	240 Participants n=5 Participants	212 Participants n=7 Participants	452 Participants n=5 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants	13 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	22 Participants n=5 Participants	32 Participants n=7 Participants	54 Participants n=5 Participants

PRIMARY outcome

Timeframe: within the first 12 months

Outcome measures

Outcome measures
Measure	Virtual Human (VH) n=473 Participants Patients were randomly assigned to a virtual human (VH) screening condition after completing the eligibility for CRC requirements. virtual technology: The app will first ask participants a short series of questions designed to assess their baseline risk for colon cancer. Highly tailored patient reminders will be customized using all 12 constructs.	Text-Base (TB) n=470 Participants Patients were randomly assigned to a text-based (TB) screening condition after completing the eligibility for CRC requirements. virtual technology: The app will first ask participants a short series of questions designed to assess their baseline risk for colon cancer. Highly tailored patient reminders will be customized using all 12 constructs.
Intention to Screen for Colorectal Cancer (CRC)	4.33 units on a scale Standard Deviation .94	4.45 units on a scale Standard Deviation .86

SECONDARY outcome

Timeframe: Assessed after 24 months

Measure: Intention to talk to doctor about colorectal cancer screening. Construct: Behavioral intention to communicate Item: I will talk to my healthcare provider about colorectal cancer screening. Scale: 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Mean scores near 1 indicate a lower intention to talk to a healthcare professional about colorectal cancer screening. Mean scores near 5 indicate a high intention to talk to a healthcare professional about colorectal cancer screening. No subscales

Outcome measures

Outcome measures
Measure	Virtual Human (VH) n=473 Participants Patients were randomly assigned to a virtual human (VH) screening condition after completing the eligibility for CRC requirements. virtual technology: The app will first ask participants a short series of questions designed to assess their baseline risk for colon cancer. Highly tailored patient reminders will be customized using all 12 constructs.	Text-Base (TB) n=470 Participants Patients were randomly assigned to a text-based (TB) screening condition after completing the eligibility for CRC requirements. virtual technology: The app will first ask participants a short series of questions designed to assess their baseline risk for colon cancer. Highly tailored patient reminders will be customized using all 12 constructs.
Communication With a Provider About Colorectal Cancer (CRC)	4.32 units on a scale Standard Deviation .91	4.33 units on a scale Standard Deviation .90

Adverse Events

Virtual Human (VH) Screening

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Text-Based (TB) Screening

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

Dr. Benjamin Lok

University of Florida

Phone: 352-214-9829

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place