FIT Mailing Protocol-For Cancer Screening Navigation

NCT02934958 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13392

Last updated 2016-10-17

No results posted yet for this study

Summary

We plan to study whether the impact of offering the choice of a pre-colonoscopy physician visit or direct referral to colonoscopy will increase adherence to colonoscopy relative to usual care in a large fecal immunochemical test (FIT) mailing campaign.

We will evaluate two study options, usual care during which patients will be required to have an office visit with wither a PCP or a Gastroenterologist prior to being scheduled for a colonoscopy, or a choice where patients will be given the option of a pre-colonoscopy visit with a gastroenterologist or PCP vs. direct referral for a colonoscopy.

In these two options we will examine colonoscopy adherence, adequacy of triage, patient satisfaction, colonoscopy outcomes (no show rate, prep quality, and pain during colonoscopy) and how insurance coverage, gender, race, education or patient understanding of colon cancer screening message during the navigation process might impact outcomes.

Conditions

  • Colorectal Neoplasms

Interventions

BEHAVIORAL

Colon Cancer Screening Navigation

Patients with FIT Positive results that have been given the choice will be followed and navigated from referral to colonoscopy to assist in obtaining colonoscopy.

BEHAVIORAL

Standard of Care

Patients will be tracked to compare how effective are usual care methods

Sponsors & Collaborators

  • Renown Regional Medical Center

    lead OTHER

Principal Investigators

  • Paul Devereux, PhD, MPH · Univeristy of Nevada, Reno

  • John Gray, MD, FACG · GI Consulatants

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-12-31
Completion
2017-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02934958 on ClinicalTrials.gov