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

Primary Purpose

Colorectal Carcinoma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention
Fecal Immunochemical Test
Questionnaire Administration
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Fred Hutch/University of Washington Cancer Consortium
  • Olympic Medical Cancer Care Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Screening (S2S education, FIT kit)

Arm Description

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

Outcomes

Primary Outcome Measures

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.
Acceptability
Four questions will be asked post-intervention to assess approval, appeal, whether the participant liked, or welcomed the S2S education.
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.
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.

Secondary Outcome Measures

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.
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).
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).
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.
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.

Full Information

First Posted
March 14, 2022
Last Updated
December 13, 2022
Sponsor
Fred Hutchinson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05291988
Brief Title
A Multilevel Approach for Improvement in Screening of Colorectal Cancer in Rural Communities, The Screen to Save Trial
Official Title
A Multilevel Approach to Improving Colorectal Cancer Screening in Rural Communities of the FH/UW Catchment Area
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to low accrual
Study Start Date
October 8, 2022 (Actual)
Primary Completion Date
November 4, 2022 (Actual)
Study Completion Date
November 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fred Hutchinson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Carcinoma

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Screening (S2S education, FIT kit)
Arm Type
Experimental
Arm Description
Participants receive S2S online screening education and FIT kit for sample collection.
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Receive S2S education
Intervention Type
Other
Intervention Name(s)
Fecal Immunochemical Test
Other Intervention Name(s)
FIT, iFOBT, immunoassay fecal occult blood test, immunochemical fecal occult blood test, Immunochemical FOBT, immunologic fecal occult blood test
Intervention Description
Receive FIT kit
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary Studies
Primary Outcome Measure Information:
Title
Accessibility
Description
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.
Time Frame
Up to 3 months
Title
Acceptability
Description
Four questions will be asked post-intervention to assess approval, appeal, whether the participant liked, or welcomed the S2S education.
Time Frame
Up to 3 months
Title
Participant uptake
Description
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.
Time Frame
Up to 3 months
Title
Demographic information
Description
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.
Time Frame
At pre-intervention only
Secondary Outcome Measure Information:
Title
Colorectal cancer knowledge
Description
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.
Time Frame
Up to 3 months
Title
Behavioral intention
Description
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).
Time Frame
Up to 3 months
Title
Social engagement
Description
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).
Time Frame
Up to 3 months
Title
Medical and colorectal cancer information
Description
Use of regular health clinic and medical providers, history of colorectal cancer screening, and family and personal history of colorectal cancer diagnosis.
Time Frame
At pre-intervention
Title
COVID-19 impact assessment
Description
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.
Time Frame
At pre-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Ceballos
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Olympic Medical Cancer Care Center
City
Sequim
State/Province
Washington
ZIP/Postal Code
98384
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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