Colorectal CancerNCT04848051
Implementing Fit Kit Colorectal Cancer (CRC) Screening in High Risk Populations
A study testing CRC screening reminder, CRC Reminder & Short message and CRC Reminder and Navigation Program in people with Colorectal Cancer, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to understand best strategies for engaging high risk populations in a primary care setting to improved adherence to colorectal cancer screening guidelines. Read more about this study
- Who is it for?
- Ages 50 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- CRC screening reminder, CRC Reminder & Short message and CRC Reminder and Navigation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,127 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2021to 21 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be 50-74 years of old at the time of enrollment
- have one valid medical encounter with CSHHC Columbus Ave. location or Dixwell location between the dates of 11/01/2019 and 11/30/2020
Who cannot join
- Documented history of colorectal cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Cornell Scott Hill Health Center
New Haven, Connecticut, 06519
About this study
The purpose of this study is to understand best strategies for engaging high risk populations in a primary care setting to improved adherence to colorectal cancer screening guidelines. The results will be used to identify best practices that are scalable to other high-risk populations who are due or overdue for colorectal cancer (CRC) screening.
Read the detailed description
This is a prospective implementation science study that will test 4 different approaches to increase colorectal cancer screening in a local primary care setting that provides services to individuals who are under-resourced. The interventions will include reminders from primary care providers with and without additional information and/or services to help complete colorectal cancer screening. A review of electronic medical records will be used to identify baseline information assessing risk factors and personal and family CRC history. For arm 3 of the study, participants may elect to enroll in our existing health navigation program. If so, additional baseline information will be collected, including information on Social Determinants of Health (SDOH). For arm 4 of the study, a questionnaire will be used to assess knowledge about colorectal cancer screening. The questionnaire will be repeated after the intervention (informational video). For all arms of the study, the primary outcome (engagement on CRC screening, receipt of CRC screening, results of CRC screening) will be collected through EPIC.
- Conditions
- Colorectal Cancer
- Being tested
- CRC screening reminder, CRC Reminder & Short message, CRC Reminder and Navigation Program, CRC Reminder & CRC education
- Keywords
- Health Screening
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRC screening reminderBehavioural
Participants randomized to the CRC Reminder arm will receive reminder that they are due/overdue for CRC screening
CRC Reminder & Short messageBehavioural
Participants randomized to the CRC Reminder \& short message arm will receive reminder that they are due/overdue for CRC screening and short message to encourage screening
CRC Reminder and Navigation ProgramBehavioural
Participants randomized to the CRC reminder and navigation program arm will receive reminder that they are due/overdue for CRC screening and short message to participate in the health navigation program that will connect participants to individually tailored resources and assistance
CRC Reminder & CRC educationBehavioural
Participants randomized to the CRC reminder and CRC education program arm will receive reminder that they are due/overdue for CRC screening and offered short educational program conducted online
| Study group | Role | What they receive |
|---|---|---|
| CRC screening reminder | Experimental | Participants randomized to the CRC Reminder arm will receive reminder that they are due/overdue for CRC screening Receives: Behavioral: CRC screening reminder |
| CRC Reminder & Short message | Experimental | Participants randomized to the CRC Reminder \& short message arm will receive reminder that they are due/overdue for CRC screening and short message to encourage screening Receives: Behavioral: CRC Reminder & Short message |
| CRC Reminder and Navigation Program | Experimental | Participants randomized to the CRC reminder and navigation program arm will receive reminder that they are due/overdue for CRC screening and short message to participate in the health navigation program that will connect participants to individually tailored resources and assistance Receives: Behavioral: CRC Reminder and Navigation Program |
| CRC Reminder & CRC education | Experimental | Participants randomized to the CRC reminder and CRC education program arm will receive reminder that they are due/overdue for CRC screening and offered short educational program conducted online Receives: Behavioral: CRC Reminder & CRC education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of participants who completed their colorectal cancer screening
The total number of participants that completed their colorectal cancer screening will be measured between the different arms
Measured: 18 months
Secondary outcomes (5)
Time to engagement
The time to engagement will be measured as the days between reminder or reminder + intervention and days to screening among the 4 arms
Measured: 18 months
Screening outcomes: results of screening
Screening outcomes will be defined as the following: descriptive summaries of the result of screening among the 4 arms.
Measured: 18 months
Screening outcomes: follow up
Screening outcomes will be defined as the following: descriptive summaries of need and completion of follow up among the 4 arms.
Measured: 18 months
Screening outcomes: biopsy results
Screening outcomes will be defined as the following: descriptive summaries of biopsy results (if needed) among the 4 arms.
Measured: 18 months
Screening outcomes: diagnostic results
Screening outcomes will be defined as the following: descriptive summaries of the diagnostic result(s) among the 4 arms.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start12 Oct 2021
- Primary completion21 Nov 2022
- Study completion21 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- None (open label)
- Enrolment
- 3,127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Beth Jones, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848051
- Sponsor's protocol ID
- 2000030006
- Other IDs
- 2P30CA016359-39
- Status last verified
- Mar 2023
- First submitted
- 12 Apr 2021
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Fit Kit Colorectal Cancer (CRC) Screening in High Risk Populations
- ClinicalTrials.gov ID
- NCT04848051
- Acronym / sponsor ID
- 2000030006
- Conditions
- Colorectal Cancer
- Keywords
- Health Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,127 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 21 Nov 2022 (actual)
- Study completion
- 21 Nov 2022 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
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 study is to understand best strategies for engaging high risk populations in a primary care setting to improved adherence to colorectal cancer screening guidelines. The results will be used to identify best practices that are scalable to other high-risk populations who are due or overdue for colorectal cancer (CRC) screening.
Detailed description
This is a prospective implementation science study that will test 4 different approaches to increase colorectal cancer screening in a local primary care setting that provides services to individuals who are under-resourced. The interventions will include reminders from primary care providers with and without additional information and/or services to help complete colorectal cancer screening. A review of electronic medical records will be used to identify baseline information assessing risk factors and personal and family CRC history. For arm 3 of the study, participants may elect to enroll in our existing health navigation program. If so, additional baseline information will be collected, including information on Social Determinants of Health (SDOH). For arm 4 of the study, a questionnaire will be used to assess knowledge about colorectal cancer screening. The questionnaire will be repeated after the intervention (informational video). For all arms of the study, the primary outcome (engagement on CRC screening, receipt of CRC screening, results of CRC screening) will be collected through EPIC.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CRC screening reminder | Experimental | Behavioral: CRC screening reminderParticipants randomized to the CRC Reminder arm will receive reminder that they are due/overdue for CRC screening |
| CRC Reminder & Short message | Experimental | Behavioral: CRC Reminder & Short messageParticipants randomized to the CRC Reminder \& short message arm will receive reminder that they are due/overdue for CRC screening and short message to encourage screening |
| CRC Reminder and Navigation Program | Experimental | Behavioral: CRC Reminder and Navigation ProgramParticipants randomized to the CRC reminder and navigation program arm will receive reminder that they are due/overdue for CRC screening and short message to participate in the health navigation program that will connect participants to individually tailored resources and assistance |
| CRC Reminder & CRC education | Experimental | Behavioral: CRC Reminder & CRC educationParticipants randomized to the CRC reminder and CRC education program arm will receive reminder that they are due/overdue for CRC screening and offered short educational program conducted online |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- be 50-74 years of old at the time of enrollment
- have one valid medical encounter with CSHHC Columbus Ave. location or Dixwell location between the dates of 11/01/2019 and 11/30/2020
Key exclusion criteria (1 listed)
- Documented history of colorectal cancer
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 |
|---|---|---|
| CRC screening reminderParticipants randomized to the CRC Reminder arm will receive reminder that they are due/overdue for CRC screening | Behavioural | CRC screening reminder |
| CRC Reminder & Short messageParticipants randomized to the CRC Reminder \& short message arm will receive reminder that they are due/overdue for CRC screening and short message to encourage screening | Behavioural | CRC Reminder & Short message |
| CRC Reminder and Navigation ProgramParticipants randomized to the CRC reminder and navigation program arm will receive reminder that they are due/overdue for CRC screening and short message to participate in the health navigation program that will connect participants to individually tailored resources and assistance | Behavioural | CRC Reminder and Navigation Program |
| CRC Reminder & CRC educationParticipants randomized to the CRC reminder and CRC education program arm will receive reminder that they are due/overdue for CRC screening and offered short educational program conducted online | Behavioural | CRC Reminder & CRC education |
Primary outcome
Total number of participants who completed their colorectal cancer screening
Time frame: 18 months
The total number of participants that completed their colorectal cancer screening will be measured between the different arms
5 secondary outcomes
Time to engagement
Time frame: 18 months
Screening outcomes: results of screening
Time frame: 18 months
Screening outcomes: follow up
Time frame: 18 months
Screening outcomes: biopsy results
Time frame: 18 months
Screening outcomes: diagnostic results
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
Beth Jones principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRC screening reminder, CRC Reminder & Short message and CRC Reminder and Navigation Program in people with Colorectal Cancer, run by Yale University 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 2 inclusion and 1 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 3 Mar 2023. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total number of participants who completed their colorectal cancer screening (time frame: 18 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 3 Mar 2023.