Colorectal CancerNCT02870049
Study to Increase Colorectal Screening
A study testing Inreach strategy, Outreach strategy and Both Inreach and Outreach strategies in people with Colorectal Cancer, run by University of California, San Diego.
Trial summary
The purpose of this study is to determine whether inreach and outreach strategies will be superior to usual care, and combination of both will be superior to either strategy alone. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Inreach strategy, Outreach strategy and Both Inreach and Outreach strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 673 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to 30 Aug 2019
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals age 50 to 75 years,
- One or more SYHC visits in the last year,
- Not uptodate with CRC screening
Who cannot join
- Individuals with personal history of CRC or colorectal polyps
About this study
Official title: A RCT of Outreach and Inreach Strategies for Boosting CRC Screening in a Federally-Qualified Health Center
The purpose of this study is to determine whether inreach and outreach strategies will be superior to usual care, and combination of both will be superior to either strategy alone.
Read the detailed description
Colorectal cancer (CRC) screening saves lives, but screening rates are low among underserved populations, particularly Latinos. The screening rate in the predominantly Latino population served by San Ysidro Health Center (SYHC, a Federally Qualified Health Center (FQHC)), is just 31%, similar to that reported for Latinos nationally, but lower than the overall national average of 65%. Previous research has demonstrated that inreach interventions at point of medical care such as patient navigation after screening referral, and outreach outside of usual medical care (such as with mailed invitations) can increase screening rates among underserved populations. However, since these have undergone limited evaluation among low income predominantly Spanish-speaking Latinos, it is unclear which approach is best, and whether implementing both approaches would be synergistic for optimizing screening rates. We hypothesize that two culturally and linguistically tailored interventions: a) an inreach strategy (IR, consisting of community health worker-delivered in clinic education regarding CRC screening and other components), and b) an outreach strategy (OS, consisting of mailed invitations to complete screening with an enclosed fecal immunochemical test (FIT) and telephone reminders) can substantially increase screening, and further, that the two interventions together will be substantially better than either alone. To test these hypotheses, we propose a randomized trial comparing usual care, IR, OS, and IR+OS for CRC screening.
- Conditions
- Colorectal Cancer
- Being tested
- Inreach strategy, Outreach strategy, Both Inreach and Outreach strategies, Usual care
- Keywords
- early detection
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inreach strategyBehavioural
Inreach strategy: In clinic education and delivery of fecal immunochemical test (FIT) kit
Outreach strategyBehavioural
Outreach strategy: Mailed fecal immunochemical test (FIT) kit and telephone reminders
Both Inreach and Outreach strategiesBehavioural
Both Inreach and Outreach strategies: Both In clinic education and delivery of fecal immunochemical test (FIT) kit and Mailed fecal immunochemical test (FIT) kit and telephone reminders
Usual careBehavioural
Usual care: FIT kit delivery as part of usual care
| Study group | Role | What they receive |
|---|---|---|
| Inreach strategy | Experimental | This consists of a community health worker-delivered in clinic education regrading CRC screening with a fecal immunochemical test (FIT) kit, and telephone reminders. Receives: Behavioral: Inreach strategy |
| Outreach strategy | Experimental | This consists of mailed invitations to complete screening with an enclosed fecal immunochemical test (FIT) kit and telephone reminders. Receives: Behavioral: Outreach strategy |
| Both Inreach and Outreach strategies | Experimental | This is a combination of the above two strategies: Inreach and Outreach combined. Receives: Behavioral: Both Inreach and Outreach strategies |
| Usual care | Active comparator | Usual care in the clinic using the fecal immunochemical test (FIT) kit. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening Completion Rate
Completion of any colorectal cancer screening test (FIT, sigmoidoscopy or colonoscopy)
Measured: 23 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startAug 2016
- Primary completion9 Jul 2018
- Study completion30 Aug 2019
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 Colorectal CancerStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 673 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- San Diego State University
- Responsible party
- Principal investigator, Samir Gupta, University of California, San Diego
- Investigators
- Samir Gupta, MD, Principal investigator, University of California, San DiegoSheila Castaneda, PhD, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870049
- Sponsor's protocol ID
- 20153270
- Other IDs
- U54132379
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2016
- Last updated
- 4 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RCT of Outreach and Inreach Strategies for Boosting CRC Screening in a Federally-Qualified Health Center
- ClinicalTrials.gov ID
- NCT02870049
- Acronym / sponsor ID
- 20153270
- Conditions
- Colorectal Cancer
- Keywords
- early detection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 673 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- San Diego State University
- Study start
- Aug 2016 (actual)
- Primary completion
- 9 Jul 2018 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 17 Aug 2016 (estimated)
- Results
- Posted 4 Sep 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 study is to determine whether inreach and outreach strategies will be superior to usual care, and combination of both will be superior to either strategy alone.
Detailed description
Colorectal cancer (CRC) screening saves lives, but screening rates are low among underserved populations, particularly Latinos. The screening rate in the predominantly Latino population served by San Ysidro Health Center (SYHC, a Federally Qualified Health Center (FQHC)), is just 31%, similar to that reported for Latinos nationally, but lower than the overall national average of 65%. Previous research has demonstrated that inreach interventions at point of medical care such as patient navigation after screening referral, and outreach outside of usual medical care (such as with mailed invitations) can increase screening rates among underserved populations. However, since these have undergone limited evaluation among low income predominantly Spanish-speaking Latinos, it is unclear which approach is best, and whether implementing both approaches would be synergistic for optimizing screening rates. We hypothesize that two culturally and linguistically tailored interventions: a) an inreach strategy (IR, consisting of community health worker-delivered in clinic education regarding CRC screening and other components), and b) an outreach strategy (OS, consisting of mailed invitations to complete screening with an enclosed fecal immunochemical test (FIT) and telephone reminders) can substantially increase screening, and further, that the two interventions together will be substantially better than either alone. To test these hypotheses, we propose a randomized trial comparing usual care, IR, OS, and IR+OS for CRC screening.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Inreach strategy | Experimental | Behavioral: Inreach strategyThis consists of a community health worker-delivered in clinic education regrading CRC screening with a fecal immunochemical test (FIT) kit, and telephone reminders. |
| Outreach strategy | Experimental | Behavioral: Outreach strategyThis consists of mailed invitations to complete screening with an enclosed fecal immunochemical test (FIT) kit and telephone reminders. |
| Both Inreach and Outreach strategies | Experimental | Behavioral: Both Inreach and Outreach strategiesThis is a combination of the above two strategies: Inreach and Outreach combined. |
| Usual care | Active comparator | Behavioral: Usual careUsual care in the clinic using the fecal immunochemical test (FIT) kit. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals age 50 to 75 years,
- One or more SYHC visits in the last year,
- Not uptodate with CRC screening
Key exclusion criteria (1 listed)
- Individuals with personal history of CRC or colorectal polyps
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 |
|---|---|---|
| Inreach strategyInreach strategy: In clinic education and delivery of fecal immunochemical test (FIT) kit | Behavioural | Inreach strategy |
| Outreach strategyOutreach strategy: Mailed fecal immunochemical test (FIT) kit and telephone reminders | Behavioural | Outreach strategy |
| Both Inreach and Outreach strategiesBoth Inreach and Outreach strategies: Both In clinic education and delivery of fecal immunochemical test (FIT) kit and Mailed fecal immunochemical test (FIT) kit and telephone reminders | Behavioural | Both Inreach and Outreach strategies |
| Usual careUsual care: FIT kit delivery as part of usual care | Behavioural | Usual care |
Primary outcome
Screening Completion Rate
Time frame: 23 months
Completion of any colorectal cancer screening test (FIT, sigmoidoscopy or colonoscopy)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 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.
Samir Gupta, MD principal investigator
University of California, San Diego
Sheila Castaneda, PhD principal investigator
San Diego State University
Questions about this trial
What is this clinical trial studying?
A study testing Inreach strategy, Outreach strategy and Both Inreach and Outreach strategies in people with Colorectal Cancer, run by University of California, San Diego.
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 3 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 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 4 Sep 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?
Screening Completion Rate (time frame: 23 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 4 Sep 2025.