Colorectal CarcinomaNCT06568016
A Clinic-wide Intervention (Primary Care-GI Connect) for Improving Rates of Colonoscopy After Abnormal Fecal Immunochemical Test Result in Patients at Federally Qualified Health Centers
A study testing Best Practice, Communication Intervention and Coordination in people with Colorectal Carcinoma, run by Jonsson Comprehensive Cancer Center at 2 sites in United States.
Trial summary
This clinical trial evaluates a clinic-wide intervention called Primary Care-Gastrointestinal (GI) Connect for improving follow-up colonoscopy rates in patients at a Federally Qualified Health Center (FQHC) who have an abnormal fecal immunochemical test (FIT) result. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Colorectal Carcinoma
- What is being tested?
- Best Practice, Communication Intervention and Coordination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Apr 2025to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 6 adult care NEVHC clinic sites
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of California at Los Angeles
Los Angeles, California, 90095-1406
Jessica J Tuan, 310-825-3181, jtuan@mednet.ucla.edu
Folasade P May, MD, PhD
- Not yet recruiting
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
Folasade P. May, 310-825-4728, fmay@mednet.ucla.edu
Folasade P. May
About this study
Official title: Multilevel Intervention to Improve Follow-up Colonoscopy Rates After Abnormal FIT Results in Large FQHC
This clinical trial evaluates a clinic-wide intervention called Primary Care-Gastrointestinal (GI) Connect for improving follow-up colonoscopy rates in patients at a Federally Qualified Health Center (FQHC) who have an abnormal fecal immunochemical test (FIT) result. Colorectal cancer screening reduces colorectal cancer incidence and mortality but is underutilized.The most accessible, feasible, and common colorectal cancer screening modality for average-risk individuals in low resource settings such as FQHCs is the stool-based FIT. However, the benefit of FIT screening on colorectal cancer risk is realized only if individuals with abnormal FIT results undergo timely follow-up colonoscopy. Follow-up colonoscopy rates are low and there are many barriers to follow-up colonoscopy in safety net settings such as FQHCs. Effective interventions that are multi-component and improve care coordination are needed to improve abnormal FIT follow-up rates in FQHCs. The Primary Care-GI Connect intervention includes components that enhance care coordination, standardize the referral process, and engage both primary care and specialist physicians. This clinic-wide intervention may improve rates of follow-up colonoscopy after abnormal FIT results in patients seen at FQHCs.
Read the detailed description
PRIMARY OBJECTIVES:
- Conduct a pragmatic, cluster randomized trial in 6 clinics (1500 patients) within a multi-site FQHC system to compare the effectiveness of the multilevel FQHC-GI care coordination intervention ("Primary Care-GI Connect "; 3 clinics, 750 patients) to the usual care condition (3 clinics, 750 patients) on receipt of a colonoscopy within 6 months of an abnormal FIT.
II. Systematically assess the quality of intervention implementation to understand the feasibility and relative importance of intervention elements as guided by the Multilevel Health Outcomes Framework.
III. Measure the incremental cost-effectiveness of the Primary Care-GI Connect intervention compared to usual care to understand the potential value, feasibility, and potential for dissemination.
OUTLINE: Northeast Valley Health Corporation (NEVHC) clinics are randomized to 1 of 2 arms.
ARM I: Patients receive clinical care consistent with current practice at NEVHC. Patients have their electronic health records (EHRs) reviewed monthly by the Primary Care FIT Tracker for abnormal FIT results and patients with abnormal FIT results receive standardized communication from FIT quality improvement (QI) champions about their results and receive a referral to gastroenterology.
ARM II: Patients receive clinical care consistent with current practice at NEVHC as described in Arm I. Patients also receive enhanced GI care coordination from GI liaisons, who generate GI FIT Tracker reports and use the GI FIT Tracker reports to follow patients with abnormal FIT results. Patients receive navigation services including contact from GI liaisons about making a GI appointment and enhanced communication between GI specialists and the NEVHC. Patients receive referral to gastroenterology following a standardized referral template and receive colonoscopy education including an informational sheet at the time of referral and a 20-minute pre-colonoscopy educational video. Patients receive a text message at the time of colonoscopy referral emphasizing the importance of colonoscopy after abnormal FIT result.
- Conditions
- Colorectal Carcinoma
- Being tested
- Best Practice, Communication Intervention, Coordination, Educational Intervention, Electronic Health Record Review
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive clinical care consistent with current practice
Communication InterventionOther
Receive standardized communication from FIT QI champion
Communication InterventionOther
Receive coordination from GI liaisons
CoordinationOther
Receive enhanced GI care coordination
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Watch pre-colonoscopy educational video
Electronic Health Record ReviewOther
Undergo FIT result review by Primary Care FIT Tracker
Electronic Health Record ReviewOther
Ancillary studies
Informational InterventionOther
Undergo generation and review of GI FIT Tracker report
Informational InterventionOther
Receive informational sheet
InterviewOther
Ancillary studies
Patient NavigationBehavioural
Also called Patient Navigator Program
Receive navigation from GI liaisons
ReferralOther
Also called Referred
Receive referral
ReferralOther
Also called Referred
Receive referral per standardized template
Text Message-Based Navigation InterventionOther
Also called Automated Text Message-Based Navigation, Text Message-Based Navigation
Receive follow-up text message
| Study group | Role | What they receive |
|---|---|---|
| Arm I (usual care) | Active comparator | Patients receive clinical care consistent with current practice at NEVHC. Patients have their EHRs reviewed monthly by the Primary Care FIT Tracker for abnormal FIT results and patients with abnormal FIT results receive standardized communication from FIT QI champions about their results and receive a referral to gastroenterology. Receives: Other: Best Practice; Other: Communication Intervention; Other: Electronic Health Record Review; Other: Interview; Other: Referral |
| Arm II (Usual care + Primary Care - GI Connect) | Experimental | Patients receive clinical care consistent with current practice at NEVHC as described in Arm I. Patients also receive enhanced GI care coordination from GI liaisons, who generate GI FIT Tracker reports and use the GI FIT Tracker reports to follow patients with abnormal FIT results. Patients receive navigation services including contact from GI liaisons about making a GI appointment and enhanced communication between GI specialists and the NEVHC. Patients receive referral to gastroenterology following a standardized referral template and receive colonoscopy education including an informational sheet at the time of referral and a 20-minute pre-colonoscopy educational video. Patients receive a text message at the time of colonoscopy referral emphasizing the importance of colonoscopy after abnormal FIT result. Receives: Other: Best Practice; Other: Communication Intervention; Other: Coordination; Other: Educational Intervention; Other: Electronic Health Record Review; Other: Informational Intervention; Other: Interview; Behavioral: Patient Navigation; Other: Referral; Other: Text Message-Based Navigation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follow-up colonoscopy rates
Evaluated in patients with an abnormal fecal immunochemical test (FIT) result using electronic health record data. Will use a difference-in-differences approach, assessing whether change in completion rates from baseline to the implementation period differs between the intervention and usual care conditions, thus accounting for potential differences among clinics pre-implementation. Will fit a mixed effects logistic regression model with a dependent variable of patient-level colonoscopy completion within 6 months (yes/no).
Measured: At 6 months
Implementation quality: fit tracker
The Investigators will measure the percent of cases for which the FIT tracker is used, as well as its use for each step in the process. For these measures, we will also measure time to completion.
Measured: Monthly intervals up to 3 years
Implementation quality: patient notification
The Investigators will measure both the percent of patients who are notified of their abnormal results as well as the time to notification.
Measured: Monthly intervals up to 3 years
Implementation quality: patient referral
The Investigators will measure the percent of patients who receive a referral.
Measured: Monthly intervals up to 3 years
Implementation quality: Time to patient referral
The Investigators will measure the time to patient referral.
Measured: Monthly intervals up to 3 years
Implementation quality: use of referral template as percent completion of interventions
The Investigators will measure the percent completion of interventions for patients at each step.
Measured: Monthly intervals up to 3 years
Implementation quality: referral template in time to completion
The Investigators will measure the time to completion of interventions.
Measured: Monthly intervals up to 3 years
Implementation quality: patient education
The Investigators will measure the percent of cases in which patient education is delivered.
Measured: Monthly intervals up to 3 years
Implementation quality: patient education
The Investigators will measure the time to delivery of patient education when it is offered.
Measured: Monthly intervals up to 3 years
Implementation quality: Patient attendance: completion of a pre-colonoscopy visit
The Investigators will measure the percent of patients who complete a pre-colonoscopy visit.
Measured: Monthly intervals up to 3 years
Implementation quality: time to completion of a pre-colonoscopy visit
The Investigators will measure the time to completion of a pre-colonoscopy visit.
Measured: Monthly intervals up to 3 years
Implementation quality: receipt of colonoscopy and pathology results at Northeast Valley Health Corporation
The Investigators will measure the percent of patients for which colonoscopy and pathology results are received at NEVHC.
Measured: Monthly intervals up to 3 years
Implementation quality: receipt of colonoscopy and pathology results at Northeast Valley Health Corporation over time
The Investigators will measure the time to retrieval of colonoscopy and pathology results received at NEVHC.
Measured: Monthly intervals up to 3 years
Cost-effectiveness
Will use standard cost-effectiveness techniques (including time discounting) to conduct an incremental cost-effectiveness analysis, measuring the Incremental Cost-Effectiveness Ratio of the usual care and Primary-care GI connect intervention conditions.
Measured: Up to 3 years
Secondary outcomes (6)
Time to colonoscopy
The Investigators will use a difference-in-differences approach, assessing whether change in completion rates from baseline to the implementation period differs between the intervention and usual care conditions, thus accounting for potential differences among clinics pre-implementation. Will fit a mixed effects logistic regression model with a dependent variable of patient-level colonoscopy completion.
Measured: 0-24 months
Follow-up colonoscopy rates
Evaluated in patients with an abnormal FIT result using electronic health record data. Will use a difference-in-differences approach, assessing whether change in completion rates from baseline to the implementation period differs between the intervention and usual care conditions, thus accounting for potential differences among clinics pre-implementation. Will fit a mixed effects logistic regression model with a dependent variable of patient-level colonoscopy completion within 9 months (yes/no).
Measured: At 9 months and at 12 months
Factors associated with Implementation
The Investigators will use the Organizational Readiness to Implement Change tool to measure responses from clinic stakeholders at each site. This is a standardized tool.
Measured: At pre-intervention (1-2 years) and at the implementation midpoint (3-4 years)
Reported challenges to implementation
In qualitative interviews with stakeholders and on standardized forms, we will learn about major challenges to implementation across clinics and over time. These will be qualitative data.
Measured: Up to 3 years
Intervention adaptations
In qualitative interviews with stakeholders, we will learn whether there were any changes we need to be intended intervention components.
Measured: Up to 3 years
Clinic and provider factors
The Investigators will use EHR data to measure clinic size, location, staffing, resources, number of providers, number of patients to evaluate associations with successful intervention implementation.
Measured: At pre-intervention (1-2 years) and at the implementation midpoint (3-4 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start22 Apr 2025
- Primary completion28 Feb 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Folasade P May, MD, PhD, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568016
- Sponsor's protocol ID
- 24-000532
- Other IDs
- NCI-2024-05892, 24-000532, P30CA016042
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2024
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multilevel Intervention to Improve Follow-up Colonoscopy Rates After Abnormal FIT Results in Large FQHC
- ClinicalTrials.gov ID
- NCT06568016
- Acronym / sponsor ID
- 24-000532
- Conditions
- Colorectal Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 23 Aug 2024 (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.
This clinical trial evaluates a clinic-wide intervention called Primary Care-Gastrointestinal (GI) Connect for improving follow-up colonoscopy rates in patients at a Federally Qualified Health Center (FQHC) who have an abnormal fecal immunochemical test (FIT) result. Colorectal cancer screening reduces colorectal cancer incidence and mortality but is underutilized.The most accessible, feasible, and common colorectal cancer screening modality for average-risk individuals in low resource settings such as FQHCs is the stool-based FIT. However, the benefit of FIT screening on colorectal cancer risk is realized only if individuals with abnormal FIT results undergo timely follow-up colonoscopy. Follow-up colonoscopy rates are low and there are many barriers to follow-up colonoscopy in safety net settings such as FQHCs. Effective interventions that are multi-component and improve care coordination are needed to improve abnormal FIT follow-up rates in FQHCs. The Primary Care-GI Connect intervention includes components that enhance care coordination, standardize the referral process, and engage both primary care and specialist physicians. This clinic-wide intervention may improve rates of follow-up colonoscopy after abnormal FIT results in patients seen at FQHCs.
Detailed description
PRIMARY OBJECTIVES:
- Conduct a pragmatic, cluster randomized trial in 6 clinics (1500 patients) within a multi-site FQHC system to compare the effectiveness of the multilevel FQHC-GI care coordination intervention ("Primary Care-GI Connect "; 3 clinics, 750 patients) to the usual care condition (3 clinics, 750 patients) on receipt of a colonoscopy within 6 months of an abnormal FIT.
II. Systematically assess the quality of intervention implementation to understand the feasibility and relative importance of intervention elements as guided by the Multilevel Health Outcomes Framework.
III. Measure the incremental cost-effectiveness of the Primary Care-GI Connect intervention compared to usual care to understand the potential value, feasibility, and potential for dissemination.
OUTLINE: Northeast Valley Health Corporation (NEVHC) clinics are randomized to 1 of 2 arms.
ARM I: Patients receive clinical care consistent with current practice at NEVHC. Patients have their electronic health records (EHRs) reviewed monthly by the Primary Care FIT Tracker for abnormal FIT results and patients with abnormal FIT results receive standardized communication from FIT quality improvement (QI) champions about their results and receive a referral to gastroenterology.
ARM II: Patients receive clinical care consistent with current practice at NEVHC as described in Arm I. Patients also receive enhanced GI care coordination from GI liaisons, who generate GI FIT Tracker reports and use the GI FIT Tracker reports to follow patients with abnormal FIT results. Patients receive navigation services including contact from GI liaisons about making a GI appointment and enhanced communication between GI specialists and the NEVHC. Patients receive referral to gastroenterology following a standardized referral template and receive colonoscopy education including an informational sheet at the time of referral and a 20-minute pre-colonoscopy educational video. Patients receive a text message at the time of colonoscopy referral emphasizing the importance of colonoscopy after abnormal FIT result.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (usual care) | Active comparator | Other: Best Practice, Other: Communication Intervention, Other: Electronic Health Record Review, Other: Interview, Other: ReferralPatients receive clinical care consistent with current practice at NEVHC. Patients have their EHRs reviewed monthly by the Primary Care FIT Tracker for abnormal FIT results and patients with abnormal FIT results receive standardized communication from FIT QI champions about their results and receive a referral to gastroenterology. |
| Arm II (Usual care + Primary Care - GI Connect) | Experimental | Other: Best Practice, Other: Communication Intervention, Other: Coordination, Other: Educational Intervention, Other: Electronic Health Record Review, Other: Informational Intervention, Other: Interview, Behavioral: Patient Navigation, Other: Referral, Other: Text Message-Based Navigation InterventionPatients receive clinical care consistent with current practice at NEVHC as described in Arm I. Patients also receive enhanced GI care coordination from GI liaisons, who generate GI FIT Tracker reports and use the GI FIT Tracker reports to follow patients with abnormal FIT results. Patients receive navigation services including contact from GI liaisons about making a GI appointment and enhanced communication between GI specialists and the NEVHC. Patients receive referral to gastroenterology following a standardized referral template and receive colonoscopy education including an informational sheet at the time of referral and a 20-minute pre-colonoscopy educational video. Patients receive a text message at the time of colonoscopy referral emphasizing the importance of colonoscopy after abnormal FIT result. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 6 adult care NEVHC clinic sites
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive clinical care consistent with current practice | Other | Arm I (usual care), Arm II (Usual care + Primary Care - GI Connect) |
| Communication InterventionReceive standardized communication from FIT QI champion | Other | Arm I (usual care), Arm II (Usual care + Primary Care - GI Connect) |
| Communication InterventionReceive coordination from GI liaisons | Other | Arm II (Usual care + Primary Care - GI Connect) |
| CoordinationReceive enhanced GI care coordination | Other | Arm II (Usual care + Primary Care - GI Connect) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalWatch pre-colonoscopy educational video | Other | Arm II (Usual care + Primary Care - GI Connect) |
| Electronic Health Record ReviewUndergo FIT result review by Primary Care FIT Tracker | Other | Arm I (usual care), Arm II (Usual care + Primary Care - GI Connect) |
| Electronic Health Record ReviewAncillary studies | Other | Arm I (usual care), Arm II (Usual care + Primary Care - GI Connect) |
| Informational InterventionUndergo generation and review of GI FIT Tracker report | Other | Arm II (Usual care + Primary Care - GI Connect) |
| Informational InterventionReceive informational sheet | Other | Arm II (Usual care + Primary Care - GI Connect) |
| InterviewAncillary studies | Other | Arm I (usual care), Arm II (Usual care + Primary Care - GI Connect) |
| Patient NavigationAlso: Patient Navigator ProgramReceive navigation from GI liaisons | Behavioural | Arm II (Usual care + Primary Care - GI Connect) |
| ReferralAlso: ReferredReceive referral | Other | Arm I (usual care) |
| ReferralAlso: ReferredReceive referral per standardized template | Other | Arm II (Usual care + Primary Care - GI Connect) |
| Text Message-Based Navigation InterventionAlso: Automated Text Message-Based Navigation, Text Message-Based NavigationReceive follow-up text message | Other | Arm II (Usual care + Primary Care - GI Connect) |
Primary outcome
Follow-up colonoscopy rates
Time frame: At 6 months
Evaluated in patients with an abnormal fecal immunochemical test (FIT) result using electronic health record data. Will use a difference-in-differences approach, assessing whether change in completion rates from baseline to the implementation period differs between the intervention and usual care conditions, thus accounting for potential differences among clinics pre-implementation. Will fit a mixed effects logistic regression model with a dependent variable of patient-level colonoscopy completion within 6 months (yes/no).
Implementation quality: fit tracker
Time frame: Monthly intervals up to 3 years
The Investigators will measure the percent of cases for which the FIT tracker is used, as well as its use for each step in the process. For these measures, we will also measure time to completion.
Implementation quality: patient notification
Time frame: Monthly intervals up to 3 years
The Investigators will measure both the percent of patients who are notified of their abnormal results as well as the time to notification.
Implementation quality: patient referral
Time frame: Monthly intervals up to 3 years
The Investigators will measure the percent of patients who receive a referral.
Implementation quality: Time to patient referral
Time frame: Monthly intervals up to 3 years
The Investigators will measure the time to patient referral.
Implementation quality: use of referral template as percent completion of interventions
Time frame: Monthly intervals up to 3 years
The Investigators will measure the percent completion of interventions for patients at each step.
Implementation quality: referral template in time to completion
Time frame: Monthly intervals up to 3 years
The Investigators will measure the time to completion of interventions.
Implementation quality: patient education
Time frame: Monthly intervals up to 3 years
The Investigators will measure the percent of cases in which patient education is delivered.
Implementation quality: patient education
Time frame: Monthly intervals up to 3 years
The Investigators will measure the time to delivery of patient education when it is offered.
Implementation quality: Patient attendance: completion of a pre-colonoscopy visit
Time frame: Monthly intervals up to 3 years
The Investigators will measure the percent of patients who complete a pre-colonoscopy visit.
Implementation quality: time to completion of a pre-colonoscopy visit
Time frame: Monthly intervals up to 3 years
The Investigators will measure the time to completion of a pre-colonoscopy visit.
Implementation quality: receipt of colonoscopy and pathology results at Northeast Valley Health Corporation
Time frame: Monthly intervals up to 3 years
The Investigators will measure the percent of patients for which colonoscopy and pathology results are received at NEVHC.
Implementation quality: receipt of colonoscopy and pathology results at Northeast Valley Health Corporation over time
Time frame: Monthly intervals up to 3 years
The Investigators will measure the time to retrieval of colonoscopy and pathology results received at NEVHC.
Cost-effectiveness
Time frame: Up to 3 years
Will use standard cost-effectiveness techniques (including time discounting) to conduct an incremental cost-effectiveness analysis, measuring the Incremental Cost-Effectiveness Ratio of the usual care and Primary-care GI connect intervention conditions.
6 secondary outcomes
Time to colonoscopy
Time frame: 0-24 months
Follow-up colonoscopy rates
Time frame: At 9 months and at 12 months
Factors associated with Implementation
Time frame: At pre-intervention (1-2 years) and at the implementation midpoint (3-4 years)
Reported challenges to implementation
Time frame: Up to 3 years
Intervention adaptations
Time frame: Up to 3 years
Clinic and provider factors
Time frame: At pre-intervention (1-2 years) and at the implementation midpoint (3-4 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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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.
Folasade P May, MD, PhD principal investigator
UCLA / Jonsson Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Communication Intervention and Coordination in people with Colorectal Carcinoma, run by Jonsson Comprehensive Cancer Center 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 1 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 2 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Tuan (310-825-3181, JTuan@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follow-up colonoscopy rates (time frame: At 6 months). The study lists 14 primary outcomes in all. 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 2 Sep 2026; AzTrials last refreshed its copy on 1 Nov 2026.