Health Service Intervention for the Improvement of Access and Adherence to Colorectal Cancer Screening

NCT ID: NCT04607291

Last Updated: 2021-08-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-05-14

Brief Summary

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This phase I study investigates how well a health service program called Witness CARES Services works in increasing access and adherence to colorectal cancer screening in patients who have not undergone a colorectal screening in the past year. Providing patients with navigational and screening services via Witness CARES Services may improve access to and adherence levels of colorectal screening.

Detailed Description

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PRIMARY OBJECTIVES:

I. Test the feasibility of Witness CARES (WC) Services to achieve colorectal carcinoma (CRC) screening for non-adherent Medicaid clients.

II. Develop an algorithm for predicting CRC screening outcomes following intervention services.

OUTLINE:

Patients who are not prepared for a colonoscopy or stool test receive educational materials, messages, and videos electronically or by mail with information about colorectal screening and are followed up by phone within 2 weeks. Patients desiring colonoscopy receive navigator assistance with obtaining the screening (e.g.,determining gastrointestinal doctor, scheduling appointment, prep materials and process, transportation, escort). Patients desiring a stool test receive navigator assistance by facilitating fecal tests.

After completion of study, patients are followed up periodically.

Conditions

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Colorectal Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Health services research (Witness CARES services) Intervention

Patients who are not prepared for a colonoscopy or stool test receive educational materials, messages, and videos electronically or by mail with information about colorectal screening and are followed up by phone within 2 weeks. Patients desiring colonoscopy, receive navigators assistance with obtaining the screening (e.g.,determining gastrointestinal doctor, scheduling appointment, prep materials and process, transportation, escort). Patients desiring a stool test, receive navigators assistance by facilitating fecal tests.

Group Type EXPERIMENTAL

Community Health Service

Intervention Type OTHER

Receive Witness CARES services

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Community Health Service

Receive Witness CARES services

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Participants who are non-adherent to CRC screening over the past year (i.e., no stool testing in past 11 months or colonoscopy for over 9 years)
* Medicaid or Medicaid/Medicare subscribers
* Uninsured patients may be included from Mercy Comprehensive Care Center (MCCC), but will only be eligible for services to obtain fecal immunochemical tests (FIT) through the New York State (NYS) Cancer Services Program

Exclusion Criteria

* Any participants from the lists of gaps in care clients from insurance or primary care practices who report having had a colonoscopy in the past 9 years (or having positive findings such as polyps, 5 years) or having completed some type of fecal test for CRC will be excluded
* Participants under 50 will be excluded unless they have been deemed high risk by their physician, and have a prescription for CRC screening
* Participants symptomatic for CRC will be excluded from the study
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Roswell Park Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Deborah Erwin

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

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Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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NCI-2019-06075

Identifier Type: REGISTRY

Identifier Source: secondary_id

I 63518

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA016056

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R41CA232824

Identifier Type: NIH

Identifier Source: secondary_id

View Link

I 63518

Identifier Type: -

Identifier Source: org_study_id

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