The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation
NCT ID: NCT03181334
Last Updated: 2021-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
7711 participants
INTERVENTIONAL
2017-09-05
2020-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evidence-Based Colorectal Cancer Screening for the Uninsured
NCT01946282
Increasing Colorectal Cancer Screening in a Safety-net Health System With a Focus on the Uninsured: Benefits and Costs
NCT01191411
FIT Mailing Protocol-For Cancer Screening Navigation
NCT02934958
Opt-In Versus Opt-Out for Colorectal Cancer Screening Outreach
NCT02929186
Colorectal Cancer (CRC) Surveillance Tool: Cognitive and Pilot Testing
NCT03180411
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Branch I
Condition 1: (Standard Intervention)
Mailed fecal immunochemical test (FIT) kit including the following:
Invitation letter to complete free colorectal cancer (CRC) screening.
Branch I
FIT kits and a Standard (control) invitation letter to complete CRC screening is mailed to the homes of eligible patients.
Branch II and Branch III
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)
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.
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.
Branch IV and Branch V
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
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Branch I
FIT kits and a Standard (control) invitation letter to complete CRC screening is mailed to the homes of eligible patients.
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.
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.
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.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
50 Years
74 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cancer Prevention Research Institute of Texas
OTHER
John Peter Smith Health Network
UNKNOWN
University of Texas Southwestern Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Keith Argenbright
Professor of Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Keith E Argenbright, MD
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center, Moncrief Cancer Institute
Samir Gupta, MD
Role: STUDY_DIRECTOR
University of California, San Diego
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
John Peter Smith Health Network
Fort Worth, Texas, United States
UT Southwestern Medical Center, Moncrief Cancer Institute
Fort Worth, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin. 2010 Sep-Oct;60(5):277-300. doi: 10.3322/caac.20073. Epub 2010 Jul 7.
StatBite: National Costs for Cancer Care in 2010 in Billions of Dollars by Cancer Site. J Natl Cancer Inst. 2012 Jan 4;104(1):13. doi: 10.1093/jnci/djr534. Epub 2011 Dec 14. No abstract available.
Ward E, Halpern M, Schrag N, Cokkinides V, DeSantis C, Bandi P, Siegel R, Stewart A, Jemal A. Association of insurance with cancer care utilization and outcomes. CA Cancer J Clin. 2008 Jan-Feb;58(1):9-31. doi: 10.3322/CA.2007.0011. Epub 2007 Dec 20.
Hardcastle JD, Chamberlain JO, Robinson MH, Moss SM, Amar SS, Balfour TW, James PD, Mangham CM. Randomised controlled trial of faecal-occult-blood screening for colorectal cancer. Lancet. 1996 Nov 30;348(9040):1472-7. doi: 10.1016/S0140-6736(96)03386-7.
Mandel JS, Bond JH, Church TR, Snover DC, Bradley GM, Schuman LM, Ederer F. Reducing mortality from colorectal cancer by screening for fecal occult blood. Minnesota Colon Cancer Control Study. N Engl J Med. 1993 May 13;328(19):1365-71. doi: 10.1056/NEJM199305133281901.
Kronborg O, Fenger C, Olsen J, Jorgensen OD, Sondergaard O. Randomised study of screening for colorectal cancer with faecal-occult-blood test. Lancet. 1996 Nov 30;348(9040):1467-71. doi: 10.1016/S0140-6736(96)03430-7.
Faivre J, Dancourt V, Lejeune C, Tazi MA, Lamour J, Gerard D, Dassonville F, Bonithon-Kopp C. Reduction in colorectal cancer mortality by fecal occult blood screening in a French controlled study. Gastroenterology. 2004 Jun;126(7):1674-80. doi: 10.1053/j.gastro.2004.02.018.
Atkin WS, Edwards R, Kralj-Hans I, Wooldrage K, Hart AR, Northover JM, Parkin DM, Wardle J, Duffy SW, Cuzick J; UK Flexible Sigmoidoscopy Trial Investigators. Once-only flexible sigmoidoscopy screening in prevention of colorectal cancer: a multicentre randomised controlled trial. Lancet. 2010 May 8;375(9726):1624-33. doi: 10.1016/S0140-6736(10)60551-X. Epub 2010 Apr 27.
Kahi CJ, Imperiale TF, Juliar BE, Rex DK. Effect of screening colonoscopy on colorectal cancer incidence and mortality. Clin Gastroenterol Hepatol. 2009 Jul;7(7):770-5; quiz 711. doi: 10.1016/j.cgh.2008.12.030. Epub 2009 Jan 11.
Brenner H, Chang-Claude J, Seiler CM, Rickert A, Hoffmeister M. Protection from colorectal cancer after colonoscopy: a population-based, case-control study. Ann Intern Med. 2011 Jan 4;154(1):22-30. doi: 10.7326/0003-4819-154-1-201101040-00004.
Baxter NN, Goldwasser MA, Paszat LF, Saskin R, Urbach DR, Rabeneck L. Association of colonoscopy and death from colorectal cancer. Ann Intern Med. 2009 Jan 6;150(1):1-8. doi: 10.7326/0003-4819-150-1-200901060-00306. Epub 2008 Dec 15.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STU 012016-034
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.