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

Study Overview
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Brief Summary
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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: 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. 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. 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
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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: The existing database of John Peter Smith patients who are part of a previous CRC screening study (STU 082012-086) 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. 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. 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. 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.

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Behavioral: Branch I
* Behavioral: Branch II
* Behavioral: Branch III
* Behavioral: Branch IV
* Behavioral: Branch V


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Uninsured or Underinsured English or Spanish speaking No history of colon cancer or colon resection No history of inflammatory bowel disease Colonoscopy not completed in the last 10 years Sigmoidoscopy not completed in the last 5 years Fecal Occult Blood Test (FOBT) or fecal immunochemical test (FIT) not completed in the last year Complete contact information on file Not incarcerated or homeless Exclusion Criteria: Under 50 or over 74 years of age Insured but not underinsured Other than English or Spanish speaking History of colon cancer or colon resection History of inflammatory bowel disease Colonoscopy completed within the last 10 years Sigmoidoscopy completed within the last 5 years FOBT or FIT screening completed within the last year Incomplete contact information (i.e., no address or phone number on file) Incarcerated or homeless

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Branch I<br>Condition 1: (Standard Intervention) Mailed fecal immunochemical test (FIT) kit including the following: Invitation letter to complete free colorectal cancer (CRC) screening. | Behavioral: Branch I<br>* FIT kits and a Standard (control) invitation letter to complete CRC screening is mailed to the homes of eligible patients.<br>* Other names: Condition 1 - Standard Intervention;|
| Experimental: Branch II and Branch III<br>Condition 2: (Time Guideline) Mailed fecal immunochemical test (FIT) kit including the following: Invitation to complete free colorectal cancer (CRC) screening within a specified time frame: Branch II - Brief Time (1-week) Branch III - Extended Time (3-weeks) | Behavioral: Branch II<br>* 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.<br>* Other names: Brief Time;Behavioral: Branch III<br>* 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.<br>* Other names: Extended Time;|
| Experimental: Branch IV and Branch V<br>Condition 3: (Time Guideline + Incentive) Mailed fecal immunochemical test (FIT) kit including the following: Invitation to complete free colorectal (CRC) screening within a specified time frame with a monetary incentive: Branch IV - High Incentive Branch V - Low Incentive | Behavioral: Branch IV<br>* 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.<br>* Other names: High Incentive;Behavioral: Branch V<br>* 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.<br>* Other names: Low Incentive;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in colorectal cancer screening rate of the 5 tested invitation approaches. | Primary analysis will be proportion of participants returning their kit within 24 days of mailing. We a priori computed sample size required to have 80% power to detect at least an 8% absolute increase in screening between each branch. We planned for 10 pairwise comparisons with a two-sided 0.005 (=0.05/10) significance level and Bonferroni correction. Estimated return rate for the control was 36.5%. Based on these parameters, we estimate requiring at least 1,026 individuals per group. To maximize sample receiving outreach, the final sample will randomize all eligible patients and is expected to be larger than 1,026 per group. | 24 days [3 week + 3 days for mailing] from time of mailed invitation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FIT, colorectal, cancer, neoplasm, CRC screening, Fecal Immunochemical Test