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

Colorectal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05291988
• Other study ID #: RG1121686
• Secondary ID: NCI-2022-0117210
• Status: Terminated
• Phase: N/A
• Start date: October 8, 2022
• Est. completion date: November 4, 2022

Study information

• Verified date: December 2022
• Source: Fred Hutchinson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: November 4, 2022
• Est. primary completion date: November 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Carcinoma
• Colorectal Neoplasms

Intervention

Other:
• Educational Intervention
Receive S2S education
• Fecal Immunochemical Test
Receive FIT kit
• Questionnaire Administration
Ancillary Studies

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington
United States	Olympic Medical Cancer Care Center	Sequim	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accessibility	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.	Up to 3 months
Primary	Acceptability	Four questions will be asked post-intervention to assess approval, appeal, whether the participant liked, or welcomed the S2S education.	Up to 3 months
Primary	Participant uptake	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.	Up to 3 months
Primary	Demographic information	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.	At pre-intervention only
Secondary	Colorectal cancer knowledge	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.	Up to 3 months
Secondary	Behavioral intention	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).	Up to 3 months
Secondary	Social engagement	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).	Up to 3 months
Secondary	Medical and colorectal cancer information	Use of regular health clinic and medical providers, history of colorectal cancer screening, and family and personal history of colorectal cancer diagnosis.	At pre-intervention
Secondary	COVID-19 impact assessment	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.	At pre-intervention