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Study to Increase Colorectal Screening

A RCT of Outreach and Inreach Strategies for Boosting CRC Screening in a Federally-Qualified Health Center

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02870049
Enrollment
673
Registered
2016-08-17
Start date
2016-08-31
Completion date
2019-08-30
Last updated
2025-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

early detection

Brief 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.

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.

Interventions

BEHAVIORALInreach strategy

Inreach strategy: In clinic education and delivery of fecal immunochemical test (FIT) kit

BEHAVIORALOutreach strategy

Outreach strategy: Mailed fecal immunochemical test (FIT) kit and telephone reminders

BEHAVIORALBoth Inreach and Outreach strategies

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

BEHAVIORALUsual care

Usual care: FIT kit delivery as part of usual care

Sponsors

San Diego State University
CollaboratorOTHER
University of California, San Diego
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SCREENING
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Individuals age 50 to 75 years, * One or more SYHC visits in the last year, * Not uptodate with CRC screening

Exclusion criteria

* Individuals with personal history of CRC or colorectal polyps

Design outcomes

Primary

MeasureTime frameDescription
Screening Completion Rate23 monthsCompletion of any colorectal cancer screening test (FIT, sigmoidoscopy or colonoscopy)

Participant flow

Participants by arm

ArmCount
Inreach Strategy
This consists of a community health worker-delivered in clinic education regrading CRC screening with a fecal immunochemical test (FIT) kit, and telephone reminders. Inreach strategy: Inreach strategy: In clinic education and delivery of fecal immunochemical test (FIT) kit
167
Outreach Strategy
This consists of mailed invitations to complete screening with an enclosed fecal immunochemical test (FIT) kit and telephone reminders. Outreach strategy: Outreach strategy: Mailed fecal immunochemical test (FIT) kit and telephone reminders
171
Both Inreach and Outreach Strategies
This is a combination of the above two strategies: Inreach and Outreach combined. Both Inreach and Outreach strategies: 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
166
Usual Care
Usual care in the clinic using the fecal immunochemical test (FIT) kit. Usual care: Usual care: FIT kit delivery as part of usual care
167
Total671

Baseline characteristics

CharacteristicInreach StrategyOutreach StrategyBoth Inreach and Outreach StrategiesUsual CareTotal
Age, Continuous59.4 years
STANDARD_DEVIATION 6.5
60.0 years
STANDARD_DEVIATION 7.1
60.0 years
STANDARD_DEVIATION 6.5
60.1 years
STANDARD_DEVIATION 6.3
59.9 years
STANDARD_DEVIATION 6.6
Ethnicity (NIH/OMB)
Hispanic or Latino
167 Participants171 Participants166 Participants167 Participants671 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Region of Enrollment
United States
167 participants171 participants166 participants167 participants671 participants
Sex: Female, Male
Female
85 Participants86 Participants86 Participants86 Participants343 Participants
Sex: Female, Male
Male
82 Participants85 Participants80 Participants81 Participants328 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 1680 / 1710 / 1670 / 167
other
Total, other adverse events
0 / 1680 / 1710 / 1670 / 167
serious
Total, serious adverse events
0 / 1680 / 1710 / 1670 / 167

Outcome results

Primary

Screening Completion Rate

Completion of any colorectal cancer screening test (FIT, sigmoidoscopy or colonoscopy)

Time frame: 23 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Inreach StrategyScreening Completion Rate46 Participants
Outreach StrategyScreening Completion Rate88 Participants
Both Inreach and Outreach StrategiesScreening Completion Rate132 Participants
Usual CareScreening Completion Rate131 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026