A Multilevel Approach for Improvement in Screening of Colorectal Cancer in Rural Communities, The Screen to Save Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Screening (S2S education, FIT kit) Participants receive S2S online screening education and FIT kit for sample collection. |
Other: Educational Intervention
Receive S2S education
Other Names:
Other: Fecal Immunochemical Test
Receive FIT kit
Other Names:
Other: Questionnaire Administration
Ancillary Studies
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
- 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.
Secondary Outcome Measures
- 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.
- 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).
- 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).
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | United States | 98109 |
| 2 | Olympic Medical Cancer Care Center | Sequim | Washington | United States | 98384 |
Sponsors and Collaborators
- Fred Hutchinson Cancer Center
Investigators
- Principal Investigator: Rachel Ceballos, Fred Hutch/University of Washington Cancer Consortium
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RG1121686
- NCI-2022-01172