Colo-rectal CancerNCT03407417
A Patient-centered Intervention Using Technology to Reduce Colorectal Cancer Disparities in Primary Care
A study testing virtual technology in people with Colo-rectal Cancer, run by University of Florida at 2 sites in United States.
Trial summary
The purpose of this proposal is to test the efficacy of a patient-centered, tailored message intervention delivered via virtual technology for increasing colorectal cancer (CRC) screening within guidelines among racial/ethnic minority and rural patients. Read more about this study
- Who is it for?
- Ages 45 to 73 yearsHealthy volunteers can take part
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- virtual technology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 960 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Nov 2018to 31 Jan 2024
- 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
- able to read English or Spanish at least at eighth-grade level
- have an email account or the ability to receive texts
- willingness to be re-contacted
- consent to MRR related to CRC screening
- not remember completing any CRC screening within recommended guidelines (i.e., <10 years for colonoscopy, <1 year for stool test).
- complete a FIT test:
Show all 9Show fewer
- a) with a negative result only
- b) complete a FIT test with a positive result AND undergo a completion screening colonoscopy,
- Or c) complete a colonoscopy only.
Who cannot join
- unable to read English at least at eighth-grade level
- doesn't have an email account or the ability to receive texts
- unwilling to be re-contacted
- Unable to consent to MRR related to CRC screening
- have not had <10 years for colonoscopy, or 1 year for stool test
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Florida
Gainesville, Florida, 32611
University of Florida
Jacksonville, Florida, 32208
About this study
The purpose of this proposal is to test the efficacy of a patient-centered, tailored message intervention delivered via virtual technology for increasing colorectal cancer (CRC) screening within guidelines among racial/ethnic minority and rural patients. This protocol focuses on the clinical portion of grant NCI 1RCA207689-01A1
Read the detailed description
Patients will be recruited via a secure, clinical data warehouse to complete a patient-randomized test of the efficacy of the intervention for promoting initial and repeat FIT testing. Patients identified as eligible will be contacted through MyChart to test a web-based, culturally-sensitive virtual human intervention for CRC screening. The web-application will provide information to encourage CRC screening. Therefore, this study is a minimal risk study.
- Conditions
- Colo-rectal Cancer
- Being tested
- virtual technology
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual technologyOther
Also called Virtual human application (ALEX)
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Human (VH) | Experimental | Patients were randomly assigned to a virtual human (VH) screening condition after completing the eligibility for CRC requirements. Receives: Other: virtual technology |
| Text-Base (TB) | Experimental | Patients were randomly assigned to a text-based (TB) screening condition after completing the eligibility for CRC requirements. Receives: Other: virtual technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intention to Screen for Colorectal Cancer (CRC)
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
Measured: within the first 12 months
Secondary outcomes (1)
Communication With a Provider About Colorectal Cancer (CRC)
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
Measured: Assessed after 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start8 Nov 2018
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
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.
- Other trials for Colo-rectal 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
- 960 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
- Benjamin Lok, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407417
- Sponsor's protocol ID
- IRB201702765 -N
- Other IDs
- 1R01CA207689-01A1, OCR17004
- Status last verified
- Apr 2025
- First submitted
- 15 Jan 2018
- Last updated
- 6 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Patient-centered Intervention Using Technology to Reduce Colorectal Cancer Disparities in Primary Care
- ClinicalTrials.gov ID
- NCT03407417
- Acronym / sponsor ID
- IRB201702765 -N
- Conditions
- Colo-rectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 960 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Posted 6 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this proposal is to test the efficacy of a patient-centered, tailored message intervention delivered via virtual technology for increasing colorectal cancer (CRC) screening within guidelines among racial/ethnic minority and rural patients. This protocol focuses on the clinical portion of grant NCI 1RCA207689-01A1
Detailed description
Patients will be recruited via a secure, clinical data warehouse to complete a patient-randomized test of the efficacy of the intervention for promoting initial and repeat FIT testing. Patients identified as eligible will be contacted through MyChart to test a web-based, culturally-sensitive virtual human intervention for CRC screening. The web-application will provide information to encourage CRC screening. Therefore, this study is a minimal risk study.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Human (VH) | Experimental | Other: virtual technologyPatients were randomly assigned to a virtual human (VH) screening condition after completing the eligibility for CRC requirements. |
| Text-Base (TB) | Experimental | Other: virtual technologyPatients were randomly assigned to a text-based (TB) screening condition after completing the eligibility for CRC requirements. |
Who may qualify
- Ages
- 45 to 73 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- able to read English or Spanish at least at eighth-grade level
- have an email account or the ability to receive texts
- willingness to be re-contacted
- consent to MRR related to CRC screening
- not remember completing any CRC screening within recommended guidelines (i.e., <10 years for colonoscopy, <1 year for stool test).
Key exclusion criteria (5 listed)
- unable to read English at least at eighth-grade level
- doesn't have an email account or the ability to receive texts
- unwilling to be re-contacted
- Unable to consent to MRR related to CRC screening
- have not had <10 years for colonoscopy, or 1 year for stool test
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 technologyAlso: Virtual human application (ALEX)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. | Other | Text-Base (TB), Virtual Human (VH) |
Primary outcome
Intention to Screen for Colorectal Cancer (CRC)
Time frame: within the first 12 months
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
1 secondary outcome
Communication With a Provider About Colorectal Cancer (CRC)
Time frame: Assessed after 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Benjamin Lok principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual technology in people with Colo-rectal Cancer, run by University of Florida at 2 sites 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 9 inclusion and 5 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 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 6 May 2025). 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?
Intention to Screen for Colorectal Cancer (CRC) (time frame: within the first 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2025.