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

NCT05291988 | Terminated

• 3 other identifiers: RG1121686NCI-2022-0117210786
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

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.

Conditions

Colorectal Carcinoma

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (5)

• Colorectal cancer knowledge

  Up to 3 months

• Behavioral intention

  Up to 3 months

• Social engagement

  Up to 3 months

• Medical and colorectal cancer information

  At pre-intervention

• COVID-19 impact assessment

  At pre-intervention

Study Arms (1)

Screening (S2S education, FIT kit)

EXPERIMENTAL

Participants receive S2S online screening education and FIT kit for sample collection.

Other: Educational Intervention; Other: Fecal Immunochemical Test; Other: Questionnaire Administration

Interventions

Educational Intervention OTHER

Receive S2S education

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Screening (S2S education, FIT kit)

Fecal Immunochemical Test OTHER

Receive FIT kit

Also known as: FIT, iFOBT, immunoassay fecal occult blood test, immunochemical fecal occult blood test, Immunochemical FOBT, immunologic fecal occult blood test

Screening (S2S education, FIT kit)

Questionnaire Administration OTHER

Ancillary Studies

Screening (S2S education, FIT kit)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 years old

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead

Study Sites (2)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Olympic Medical Cancer Care Center

Sequim, Washington, 98384, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Early Intervention, Educational; Educational Status; Methods

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques

Study Officials

• Rachel Ceballos

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: March 23, 2022
• Study Start: October 8, 2022
• Primary Completion: November 4, 2022
• Study Completion: November 4, 2022
• Last Updated: December 15, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)