The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation
NCT03181334 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7711
Last updated 2021-04-28
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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