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

NCT ID: NCT05291988

Last Updated: 2022-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-08

Study Completion Date

2022-11-04

Brief Summary

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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

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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.

Conditions

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Colorectal Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Screening (S2S education, FIT kit)

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

Group Type EXPERIMENTAL

Educational Intervention

Intervention Type OTHER

Receive S2S education

Fecal Immunochemical Test

Intervention Type OTHER

Receive FIT kit

Questionnaire Administration

Intervention Type OTHER

Ancillary Studies

Interventions

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Educational Intervention

Receive S2S education

Intervention Type OTHER

Fecal Immunochemical Test

Receive FIT kit

Intervention Type OTHER

Questionnaire Administration

Ancillary Studies

Intervention Type OTHER

Other Intervention Names

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Education for Intervention Intervention by Education Intervention through Education Intervention, Educational FIT iFOBT immunoassay fecal occult blood test immunochemical fecal occult blood test Immunochemical FOBT immunologic fecal occult blood test

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rachel Ceballos

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

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Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status

Olympic Medical Cancer Care Center

Sequim, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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NCI-2022-01172

Identifier Type: REGISTRY

Identifier Source: secondary_id

10786

Identifier Type: OTHER

Identifier Source: secondary_id

RG1121686

Identifier Type: -

Identifier Source: org_study_id