The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation

NCT03181334 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7711

Last updated 2021-04-28

No results posted yet for this study

Summary

Participants will be mailed an invitation to complete CRC screening along with a fecal immunochemical test (FIT) kit, containing a 1-sample "Polymedco Over the Counter (OC) Sensor FIT", simplified English/Spanish instructions on performing the test, educational information about colorectal cancer screening and a return mailer with prepaid postage.

Processes that will be used to promote screening completion include automated and "live" phone call reminders to encourage completion of FIT testing.

Participants will be randomly assigned to 1 of 5 interventions across 3 conditions, described below:

1. Condition 1 (Standard Intervention):

* Branch I: Participants assigned to the control condition will receive a FIT kit and the standard invitation letter to participate in free screening.
2. Condition 2 (Time Guideline):

* Branch II: Participants will receive a FIT kit and invitation letter to participate in free screening with a 1-week time restriction.
* Branch III: Participants will receive a FIT kit and invitation letter to participate in free screening with a 3-week time restriction.
3. Condition 3 (Time Guideline + Incentive):

* Branch IV: Participants will receive a FIT kit and invitation letter to participate in free screening requesting they return the kit within 1-week for a "higher" monetary incentive or within 3 weeks for a "lower" (half of the higher) monetary incentive.
* Branch V: Participants will receive a FIT kit and invitation letter to participate in free screening requesting they return the kit within 1-week for a "higher" (same as lower in Branch IV) monetary incentive or within 3 weeks for a "lower" (half of the higher) monetary incentive.

Participants with a normal test result will receive a personal letter confirming this with invitations to complete a repeat screening in subsequent year(s). Participants receiving an abnormal FIT result will be navigated to complete a diagnostic colonoscopy.

Participants continuing in the screening program in subsequent years will receive letters emphasizing the importance of repeat screening to prevent adverse CRC outcomes.

Conditions

Interventions

BEHAVIORAL

Branch I

FIT kits and a Standard (control) invitation letter to complete CRC screening is mailed to the homes of eligible patients.

BEHAVIORAL

Branch II

FIT kits and a Brief Time invitation to complete CRC screening is mailed to the homes of eligible patients. Time letters are used to evaluate the effect of procrastination on CRC screening compliance. Participants are assigned to the following intervention: Branch II: Invitation letter to participate in free CRC screening, requesting they return the kit within 1-week.

BEHAVIORAL

Branch III

FIT kits and an Extended Time invitation to complete CRC screening is mailed to the homes of eligible patients. Time letters are used to evaluate the effect of procrastination on CRC screening compliance. Participants are assigned to the following intervention: Branch III: Invitation letter to participate in free CRC screening, requesting they return the kit within 3-weeks.

BEHAVIORAL

Branch IV

FIT kits and a Time + Incentive invitation to complete CRC screening is mailed to the homes of eligible patients. Time + Incentive letters are used to evaluate the effect of incentive on procrastination in CRC screening compliance. Participants are assigned to the following intervention: Branch IV: Invitation letter to participate in free CRC screening, requesting they return the kit within 1-week for a "higher" incentive or within 3-weeks for a "lower" (half of the higher) incentive.

BEHAVIORAL

Branch V

FIT kits and a Time + Incentive invitation to complete CRC screening is mailed to the homes of eligible patients. Time + Incentive letters are used to evaluate the effect of incentive on procrastination in CRC screening compliance. Participants are assigned to the following intervention: Branch V: Invitation letter to participate in free CRC screening, requesting they return the kit within 1-week for a "higher" (same as lower Branch IV) or within 3-weeks for a "lower" (half of lower Branch IV) incentive.

Sponsors & Collaborators

  • Cancer Prevention Research Institute of Texas

    collaborator OTHER
  • John Peter Smith Health Network

    collaborator UNKNOWN
  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Keith E Argenbright, MD · UT Southwestern Medical Center, Moncrief Cancer Institute

  • Samir Gupta, MD · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-09-05
Primary Completion
2018-03-15
Completion
2020-12-31

Countries

  • United States

Study Locations

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Entities

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 NCT03181334 on ClinicalTrials.gov