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A Multilevel Approach for Improvement in Screening of Colorectal Cancer in Rural Communities, The Screen to Save Trial

A Multilevel Approach to Improving Colorectal Cancer Screening in Rural Communities of the FH/UW Catchment Area

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05291988
Enrollment
8
Registered
2022-03-23
Start date
2022-10-08
Completion date
2022-11-04
Last updated
2022-12-15

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

Conditions

Colorectal Carcinoma

Brief summary

This clinical trial determines the feasibility of a multilevel approach to improve colorectal cancer screening within two rural regions of the Fred Hutchinson Cancer Research Center/University of Washington Consortium catchment area. The catchment area is the greater Puget Sound Region (13 counties). These rural counties have the highest overall rates of cancer incidence and mortality in the area; rural/small town residents in the catchment area had the lowest rates of meeting mammogram, Pap, and colorectal screening recommendations. This study involves observational data and questionnaire assessments to determine if an online version of the evidence-informed national colorectal cancer screening program, known as Screen to Save (S2S) and a fecal immunochemical test (FIT) kit distribution are acceptable and accessible to patients. FIT kits may help doctors find colorectal cancer sooner, when it may be easier to treat.

Detailed description

OUTLINE: Participants receive S2S online screening education and FIT kit for sample collection. After completion of study intervention, patients are followed up at 3 months.

Interventions

OTHEREducational Intervention

Receive S2S education

Receive FIT kit

OTHERQuestionnaire Administration

Ancillary Studies

Sponsors

Fred Hutchinson Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age 45 years or older or \< 45 years old with family history of CRC * Speak and read English or Spanish * Current resident in Clallam county * Currently non-adherent to CRC screening recommendations

Exclusion criteria

* Age \< 18 years old

Design outcomes

Primary

MeasureTime frameDescription
AccessibilityUp to 3 monthsThree questions will be asked post-intervention to assess fit of the screen to save (S2S) education, suitability, and usefulness of the useful for learning about colorectal cancer (CRC) and CRC screening.
AcceptabilityUp to 3 monthsFour questions will be asked post-intervention to assess approval, appeal, whether the participant liked, or welcomed the S2S education.
Participant uptakeUp to 3 monthsFeasibility evaluation will include assessment of the number of participants that respond to the letter of invitation to 1) participate in the educational portion of the project by viewing the online S2S education and completing the online questionnaires and 2) complete the pick-up and return of the FIT Kit. This will be assessed through participant tracking and follow-up procedures.
Demographic informationAt pre-intervention onlyThe following demographic information will be collected: participant's age, gender, race/ethnicity, preferred language, household income, highest level of education, insurance status, ZIP code, country of origin, and years of United States (U.S.) residence. Demographics will be analyzed within each group using Chi-square or Fisher's exact test for paired binary data.

Secondary

MeasureTime frameDescription
Colorectal cancer knowledgeUp to 3 monthsKnowledge will be assessed pre- and post-intervention. The knowledge scale will include 5 multiple choice knowledge questions about colorectal screening and colorectal cancer presented as part of the S2S inflatable colon education.
COVID-19 impact assessmentAt pre-interventionA single question about the impact of COVID-19 on the decision to get colorectal cancer screening will determine if non-adherence was related to COVID-19. A yes/no response will be required.
Behavioral intentionUp to 3 monthsIntention to get CRC screening will be assessed using one question with a 5-point response option (1 = Very Unlikely, 2 = Somewhat Unlikely, 3 = Neutral, 4 = Somewhat Likely, 5 = Very Likely).
Social engagementUp to 3 monthsSocial engagement likelihood will be measure using a single question about their intention to share information learned during the S2S education with others (parents, grandparents, relatives, peers, community members).
Medical and colorectal cancer informationAt pre-interventionUse of regular health clinic and medical providers, history of colorectal cancer screening, and family and personal history of colorectal cancer diagnosis.

Countries

United States

Outcome results

None listed

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