The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

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.
    

Detailed description: 
      Eligible subjects will be identified from John Peter Smith (JPS) Health Network. A
      preliminary aggregate report suggests 10,000 patients may be identified for screening
      evaluation.

      Data compilation and management will be centralized at the University of Texas (UT)
      Southwestern Medical Center - Moncrief Cancer Institute (MCI) using John Peter Smith Health
      Network administrative claims data to assess screening rates while individually identifying
      patients not up-to-date with screening. Data will be queried to identify all 50-74 year olds
      who are potentially eligible for program inclusion.

      Data sources will include:

        1. The existing database of John Peter Smith patients who are part of a previous CRC
           screening study (STU 082012-086)

        2. Administrative and electronic medical record databases from JPS

      Patient datasets provided by John Peter Smith Health Network will be obtained through a data
      use agreement. Inclusion/exclusion criteria will be applied prior to data transfer. The
      dataset will be transferred through secure, data encrypted transfer systems data encrypted
      universal serial bus (USB) drives.

      Data required for inviting patients to screening and follow-up provided by JPS will be
      imported into the study tracking database. The tracking database facilitates the day to day
      program activities and associated data collection, maintaining work lists of patients who
      have been mailed fecal immunochemical test (FIT) kits and are due for a follow up phone
      reminder to complete and return the test. The database also accepts updated patient results,
      such as FIT and colonoscopy test results.

      Procedures:

      The screening outreach team will be responsible for sending out all invitation letters,
      tracking results, and facilitating follow up for patients with normal and abnormal FIT tests.
      Included with the invitation letter, will be a FIT kit, containing a 1-sample Polymedco OC
      Sensor FIT, simplified English/Spanish instructions on performing the test, educational
      information about CRC screening and a return mailer with prepaid postage. Completing the test
      will not require any dietary or medication restrictions for the patient.

      Screen eligible individuals will be randomized to 1 of 5 study interventions across 3
      conditions (arms) and mailed the appropriate screening invitation letter as 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 request that they complete the test and mail back within
                1-week.

             -  Branch III: Participants will receive a FIT kit and invitation letter to
                participate in free screening with a request that they complete the test and mail
                back within 3-weeks.

        3. Condition 3 (Time Guideline + Incentive):

             -  Branch IV: Participants will receive a FIT kit and invitation letter to participate
                in free screening requesting that they complete the test and mail back 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 that they complete the test and mail back within
                1-week for a "higher" (same as lower in Branch IV) or within 3 weeks for a "lower"
                (half of the higher) monetary incentive.

      Patients invited to participate in screening will receive automated telephone calls at the
      time of invitation. "Live" reminder phone calls will begin at three weeks post invitation for
      those patients not yet returning a test kit. Bilingual (English/Spanish) program staff will
      use standardized scripts when completing these calls.

      Patients receiving a normal test result will receive a personal letter confirming this with
      invitations to complete a repeat screening in subsequent year(s).

      Patients receiving an abnormal FIT result will be navigated to complete a diagnostic
      colonoscopy in the Endoscopy suite at JPS hospital. These patients will be contacted by the
      screening team to be scheduled for pre-operative appointment, after which the patient will
      then be scheduled for a colonoscopy. The study team's goal will be to schedule and complete
      colonoscopies within 8 weeks of the abnormal FIT result. If a patient prefers to schedule
      their colonoscopy with a Non-JPS primary care physician or provider, they will be allowed to
      do so. In such circumstances the study team will navigate patients to colonoscopy and
      follow-up with their own provider as with all other JPS patients.

      All results and recommendations will also be communicated with both the patient and primary
      care provider via mail within one week of receiving the result.

      Patients identified with colorectal cancer will be navigated to a treatment consultation
      visit with a surgical or medical oncology clinic, if the diagnosing colonoscopist has not
      already scheduled this follow-up appointment. The study team's goal will be for patients to
      be scheduled for this first consultation visit within one week of the CRC diagnosis. Patients
      will receive reminder phone calls for these visits at both five days and two days prior to
      the scheduled appointment.
    

Intervention name(s): Branch I; Branch II; Branch III; Branch IV; Branch V
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): FIT kits and a Standard (control) invitation letter to complete CRC screening is mailed to the homes of eligible patients.; 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.; 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.; 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.; 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.
Other intervention name(s): Condition 1 - Standard Intervention; Condition 2 - Time Guideline; Brief Time; Condition 2 - Time Guideline; Extended Time; Condition 3 - Time Guideline + Incentive; High Incentive; Condition 3 - Time Guideline + Incentive; Low Incentive
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: colorectal; cancer; neoplasm; CRC screening; FIT; Fecal Immunochemical Test