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

NCT03181334 | Completed

• 1 other identifier: STU 012016-034
• Study Type: interventional
• Target: 7,711
• Locations: 1 country
• Sites: 2

Brief 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:

• 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.

Conditions

Colorectal Cancer

Keywords

colorectal; cancer; neoplasm; CRC screening; FIT; Fecal Immunochemical Test

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Branch I

ACTIVE COMPARATOR

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

Branch II and Branch III

EXPERIMENTAL

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; Behavioral: Branch III

Branch IV and Branch V

EXPERIMENTAL

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; Behavioral: Branch V

Interventions

Branch I BEHAVIORAL

FIT kits and a Standard (control) invitation letter to complete CRC screening is mailed to the homes of eligible patients.

Also known as: Condition 1 - Standard Intervention

Branch I

Branch II BEHAVIORAL

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.

Also known as: Condition 2 - Time Guideline, Brief Time

Branch II and Branch III

Branch III BEHAVIORAL

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.

Also known as: Condition 2 - Time Guideline, Extended Time

Branch II and Branch III

Branch IV BEHAVIORAL

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.

Also known as: Condition 3 - Time Guideline + Incentive, High Incentive

Branch IV and Branch V

Branch V BEHAVIORAL

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.

Also known as: Condition 3 - Time Guideline + Incentive, Low Incentive

Branch IV and Branch V

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Cancer Prevention Research Institute of Texas: collaborator
• John Peter Smith Health Network: collaborator

Study Sites (2)

John Peter Smith Health Network

Fort Worth, Texas, 76104, United States

Location

UT Southwestern Medical Center, Moncrief Cancer Institute

Fort Worth, Texas, 76104, United States

Location

Related Publications (11)

• 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.

  PMID: 20610543 BACKGROUND

• 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.

  PMID: 22173584 BACKGROUND

• 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.

  PMID: 18096863 BACKGROUND

• 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.

  PMID: 8942775 BACKGROUND

• 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.

  PMID: 8474513 BACKGROUND

• 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.

  PMID: 8942774 BACKGROUND

• 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.

  PMID: 15188160 BACKGROUND

• 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.

  PMID: 20430429 BACKGROUND

• 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.

  PMID: 19268269 BACKGROUND

• 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.

  PMID: 21200035 BACKGROUND

• 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.

  PMID: 19075198 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Keith E Argenbright, MD

  UT Southwestern Medical Center, Moncrief Cancer Institute

  PRINCIPAL INVESTIGATOR

• Samir Gupta, MD

  University of California, San Diego

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 8, 2017
• Study Start: September 5, 2017
• Primary Completion: March 15, 2018
• Study Completion: December 31, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

US (2)