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

Not Applicable

Terminated

• Conditions: Colorectal Carcinoma
• Interventions: Other: Educational Intervention; Other: Fecal Immunochemical Test; Other: Questionnaire Administration

• Registration Number: NCT05291988
• Lead Sponsor: Fred Hutchinson Cancer Center

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.

Study Timeline

• Study First Submitted: 2022-03-14
• Study First Submitted QC: 2022-03-14
• Study First Posted: 2022-03-23
• Study Start: 2022-10-08
• Primary Completion: 2022-11-04
• Study Completion: 2022-11-04
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-13
• Last Update Posted: 2022-12-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Screening (S2S education, FIT kit)	Questionnaire Administration	Participants receive S2S online screening education and FIT kit for sample collection.
Screening (S2S education, FIT kit)	Educational Intervention	Participants receive S2S online screening education and FIT kit for sample collection.
Screening (S2S education, FIT kit)	Fecal Immunochemical Test	Participants receive S2S online screening education and FIT kit for sample collection.

Primary Outcome Measures

Name	Time	Method
Demographic information	At pre-intervention only	The 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.
Acceptability	Up to 3 months	Four questions will be asked post-intervention to assess approval, appeal, whether the participant liked, or welcomed the S2S education.
Participant uptake	Up to 3 months	Feasibility 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.
Accessibility	Up to 3 months	Three 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.

Secondary Outcome Measures

Name	Time	Method
Behavioral intention	Up to 3 months	Intention 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).
Colorectal cancer knowledge	Up to 3 months	Knowledge 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.
Medical and colorectal cancer information	At pre-intervention	Use of regular health clinic and medical providers, history of colorectal cancer screening, and family and personal history of colorectal cancer diagnosis.
COVID-19 impact assessment	At pre-intervention	A 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.
Social engagement	Up to 3 months	Social 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).

Trial Locations

Locations (2)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States

Olympic Medical Cancer Care Center; 🇺🇸 Sequim, Washington, United States