Colorectal CarcinomaNCT06090643
Implementation Research to Increase Colorectal Cancer Screening Rates Among Low Income and Ethnic Minority Groups
A study testing Best Practice, Consultation and Educational Intervention in people with Colorectal Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial implements research strategies to increase colorectal cancer (CRC) screening rates among low income and ethnic minority groups. CRC is the second most common cause of cancer mortality in the United States and disproportionately burdens low income and ethnic minority groups. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Carcinoma
- What is being tested?
- Best Practice, Consultation and Educational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,745 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 1 Nov 2027
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PATIENTS: 50-75 years of age
- PATIENTS: >= 1 clinic visit/past 2 years
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: Implementation Research to Reduce Colorectal Cancer Disparities
This clinical trial implements research strategies to increase colorectal cancer (CRC) screening rates among low income and ethnic minority groups. CRC is the second most common cause of cancer mortality in the United States and disproportionately burdens low income and ethnic minority groups. Fecal immunochemical testing (FIT) is a test to check for blood in the stool. A brush is used to collect water drops from around the surface of a stool while it is still in the toilet bowl. The samples are then sent to a laboratory, where they are checked for a human blood protein. Blood in the stool may be a sign of colorectal cancer. Despite its potential for reducing CRC incidence and mortality, screening remains woefully underutilized. There is an unmet need for practical and effective programs to improve CRC screening rates. By implementing a culturally-tailored screening CRC program that supports providers and clinic staff to encourage eligible patients to complete FIT, researchers hope to reduce cancer disparities among low-income and ethnic groups and increase the CRC screening rate, which will help providers find CRC sooner, when it may be easier to treat.
Read the detailed description
PRIMARY OBJECTIVE:
- To increase CRC screening rates within Northeast Valley Health Corporation (NEVHC).
OUTLINE: Clinic sites are randomized to 1 of 2 groups.
GROUP I CLINICS: Physicians and clinic staff receive ongoing training, education, and feedback on CRC screening, and utilize point-of-care clinical decision support tool throughout the trial. Patients receive CRC screening recommendations from provider, a FIT kit with culturally tailored instructions, consultation with clinic staff, and text message reminders throughout the trial.
GROUP II CLINICS: Physicians and clinic staff provide and patients receive CRC screening usual care throughout the trial.
- Conditions
- Colorectal Carcinoma
- Being tested
- Best Practice, Consultation, Educational Intervention, Electronic Health Record Review, Fecal Immunochemical Test
- 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 CRC screening usual care
ConsultationOther
Also called Consult
Receive consultation with clinic staff
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive education and training on CRC screening
Electronic Health Record ReviewOther
Ancillary studies
Fecal Immunochemical TestOther
Also called FIT, iFOBT, immunoassay fecal occult blood test, immunochemical fecal occult blood test
Receive FIT kit with culturally tailored instructions
FeedbackBehavioural
Receive feedback on CRC screening
Health EducationBehavioural
Receive CRC screening recommendations
Support Education ActivityOther
Utilize clinical decision support tool
Text Message-Based Navigation InterventionOther
Also called Automated Text Message-Based Navigation, Text Message-Based Navigation
Receive text message reminders
| Study group | Role | What they receive |
|---|---|---|
| Arm II (usual care) | Active comparator | Physicians and clinic staff provide and patients receive CRC screening usual care throughout the trial. Receives: Other: Best Practice; Other: Electronic Health Record Review |
| Group I (education, feedback, consult, FIT kit, text message) | Experimental | Physicians and clinic staff receive ongoing training, education, and feedback on CRC screening, and utilize point-of-care clinical decision support tool throughout the trial. Patients receive CRC screening recommendations from provider, a FIT kit with culturally tailored instructions, consultation with clinic staff, and text message reminders throughout the trial. Receives: Other: Consultation; Other: Educational Intervention; Other: Electronic Health Record Review; Other: Fecal Immunochemical Test; Behavioral: Feedback; Behavioral: Health Education; Other: Support Education Activity; Other: Text Message-Based Navigation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal cancer (CRC) screening rate
Patient-level study data on the primary outcome of CRC screening receipt will be assessed through electronic health record data systems. Fecal immunochemical test (FIT) is the screening method most commonly utilized in NEVHC. Patients who have completed a FIT within the past 12 months will be considered screened. Consistent with current CRC screening guidelines, patients screened via a flexible sigmoidoscopy in the past five years (very rare) or colonoscopy (very small numbers) in the past ten years will also be considered screened. The data will be analyzed using generalized linear mixed models that account for clustering within clinic and provider and multiple observations within patients.
Measured: Up to 3 years
Rate of failure to provide a FIT kit to an eligible patient making a clinic visit
Missed opportunity rates will be calculated at baseline, end of study, and intermediate time points by determining the number of eligible patients who made a clinic visit but did not receive a FIT kit. The data will be analyzed using generalized linear mixed models that account for clustering within clinic and provider and multiple observations within patients.
Measured: Up to 3 years
Return rate of completed FIT kits
The data will be analyzed using generalized linear mixed models that account for clustering within clinic and provider and multiple observations within patients.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Nov 2019
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2027 (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.
- More trials run by Jonsson Comprehensive Cancer CenterThe 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
- 9,745 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Responsible party
- Sponsor
- Investigators
- Roshan Bastani, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090643
- Sponsor's protocol ID
- 18-001069
- Other IDs
- NCI-2022-07503
- Status last verified
- Nov 2025
- First submitted
- 13 Oct 2023
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Research to Reduce Colorectal Cancer Disparities
- ClinicalTrials.gov ID
- NCT06090643
- Acronym / sponsor ID
- 18-001069
- Conditions
- Colorectal Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 9,745 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 19 Oct 2023 (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 implements research strategies to increase colorectal cancer (CRC) screening rates among low income and ethnic minority groups. CRC is the second most common cause of cancer mortality in the United States and disproportionately burdens low income and ethnic minority groups. Fecal immunochemical testing (FIT) is a test to check for blood in the stool. A brush is used to collect water drops from around the surface of a stool while it is still in the toilet bowl. The samples are then sent to a laboratory, where they are checked for a human blood protein. Blood in the stool may be a sign of colorectal cancer. Despite its potential for reducing CRC incidence and mortality, screening remains woefully underutilized. There is an unmet need for practical and effective programs to improve CRC screening rates. By implementing a culturally-tailored screening CRC program that supports providers and clinic staff to encourage eligible patients to complete FIT, researchers hope to reduce cancer disparities among low-income and ethnic groups and increase the CRC screening rate, which will help providers find CRC sooner, when it may be easier to treat.
Detailed description
PRIMARY OBJECTIVE:
- To increase CRC screening rates within Northeast Valley Health Corporation (NEVHC).
OUTLINE: Clinic sites are randomized to 1 of 2 groups.
GROUP I CLINICS: Physicians and clinic staff receive ongoing training, education, and feedback on CRC screening, and utilize point-of-care clinical decision support tool throughout the trial. Patients receive CRC screening recommendations from provider, a FIT kit with culturally tailored instructions, consultation with clinic staff, and text message reminders throughout the trial.
GROUP II CLINICS: Physicians and clinic staff provide and patients receive CRC screening usual care throughout the trial.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm II (usual care) | Active comparator | Other: Best Practice, Other: Electronic Health Record ReviewPhysicians and clinic staff provide and patients receive CRC screening usual care throughout the trial. |
| Group I (education, feedback, consult, FIT kit, text message) | Experimental | Other: Consultation, Other: Educational Intervention, Other: Electronic Health Record Review, Other: Fecal Immunochemical Test, Behavioral: Feedback, Behavioral: Health Education, Other: Support Education Activity, Other: Text Message-Based Navigation InterventionPhysicians and clinic staff receive ongoing training, education, and feedback on CRC screening, and utilize point-of-care clinical decision support tool throughout the trial. Patients receive CRC screening recommendations from provider, a FIT kit with culturally tailored instructions, consultation with clinic staff, and text message reminders throughout the trial. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- PATIENTS: 50-75 years of age
- PATIENTS: >= 1 clinic visit/past 2 years
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 CRC screening usual care | Other | Arm II (usual care) |
| ConsultationAlso: ConsultReceive consultation with clinic staff | Other | Group I (education, feedback, consult, FIT kit, text message) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive education and training on CRC screening | Other | Group I (education, feedback, consult, FIT kit, text message) |
| Electronic Health Record ReviewAncillary studies | Other | Arm II (usual care), Group I (education, feedback, consult, FIT kit, text message) |
| Fecal Immunochemical TestAlso: FIT, iFOBT, immunoassay fecal occult blood test, immunochemical fecal occult blood testReceive FIT kit with culturally tailored instructions | Other | Group I (education, feedback, consult, FIT kit, text message) |
| FeedbackReceive feedback on CRC screening | Behavioural | Group I (education, feedback, consult, FIT kit, text message) |
| Health EducationReceive CRC screening recommendations | Behavioural | Group I (education, feedback, consult, FIT kit, text message) |
| Support Education ActivityUtilize clinical decision support tool | Other | Group I (education, feedback, consult, FIT kit, text message) |
| Text Message-Based Navigation InterventionAlso: Automated Text Message-Based Navigation, Text Message-Based NavigationReceive text message reminders | Other | Group I (education, feedback, consult, FIT kit, text message) |
Primary outcome
Colorectal cancer (CRC) screening rate
Time frame: Up to 3 years
Patient-level study data on the primary outcome of CRC screening receipt will be assessed through electronic health record data systems. Fecal immunochemical test (FIT) is the screening method most commonly utilized in NEVHC. Patients who have completed a FIT within the past 12 months will be considered screened. Consistent with current CRC screening guidelines, patients screened via a flexible sigmoidoscopy in the past five years (very rare) or colonoscopy (very small numbers) in the past ten years will also be considered screened. The data will be analyzed using generalized linear mixed models that account for clustering within clinic and provider and multiple observations within patients.
Rate of failure to provide a FIT kit to an eligible patient making a clinic visit
Time frame: Up to 3 years
Missed opportunity rates will be calculated at baseline, end of study, and intermediate time points by determining the number of eligible patients who made a clinic visit but did not receive a FIT kit. The data will be analyzed using generalized linear mixed models that account for clustering within clinic and provider and multiple observations within patients.
Return rate of completed FIT kits
Time frame: Up to 3 years
The data will be analyzed using generalized linear mixed models that account for clustering within clinic and provider and multiple observations within patients.
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 14 Nov 2025.
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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.
Roshan Bastani principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Consultation and Educational Intervention in people with Colorectal Carcinoma, run by Jonsson Comprehensive Cancer Center 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 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: under way, not looking for participants, as of the sponsor's last update on 14 Nov 2025. 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?
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?
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?
Colorectal cancer (CRC) screening rate (time frame: Up to 3 years). The study lists 3 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 14 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.