The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Colorectal Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 50 - 74 |
| Updated: | 10/27/2018 |
| Start Date: | September 5, 2017 |
| End Date: | December 2020 |
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.
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.
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.
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.
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
We found this trial at
2
sites
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400 West Magnolia Avenue
Fort Worth, Texas 76104
Fort Worth, Texas 76104
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