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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03181334
Recruitment Status : Enrolling by invitation
First Posted : June 8, 2017
Last Update Posted : October 29, 2019
Sponsor:
Collaborators:
Cancer Prevention Research Institute of Texas
John Peter Smith Health Network
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

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:

  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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: Branch I Behavioral: Branch II Behavioral: Branch III Behavioral: Branch IV Behavioral: Branch V Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation
Actual Study Start Date : September 5, 2017
Actual Primary Completion Date : March 15, 2018
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Active Comparator: Branch I

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
FIT kits and a Standard (control) invitation letter to complete CRC screening is mailed to the homes of eligible patients.
Other Name: Condition 1 - Standard Intervention

Experimental: 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)

Behavioral: 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.

Other Names:
  • Condition 2 - Time Guideline
  • Brief Time

Behavioral: 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.

Other Names:
  • Condition 2 - Time Guideline
  • Extended Time

Experimental: 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

Behavioral: 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.

Other Names:
  • Condition 3 - Time Guideline + Incentive
  • High Incentive

Behavioral: 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 Names:
  • Condition 3 - Time Guideline + Incentive
  • Low Incentive




Primary Outcome Measures :
  1. Increase in colorectal cancer screening rate of the 5 tested invitation approaches. [ Time Frame: 24 days [3 week + 3 days for mailing] from time of mailed invitation ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03181334


Locations
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United States, Texas
John Peter Smith Health Network
Fort Worth, Texas, United States, 76104
UT Southwestern Medical Center, Moncrief Cancer Institute
Fort Worth, Texas, United States, 76104
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Cancer Prevention Research Institute of Texas
John Peter Smith Health Network
Investigators
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Principal Investigator: Keith E Argenbright, MD UT Southwestern Medical Center, Moncrief Cancer Institute
Study Director: Samir Gupta, MD University of California, San Diego

Publications:

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03181334    
Other Study ID Numbers: STU 012016-034
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Texas Southwestern Medical Center:
colorectal
cancer
neoplasm
CRC screening
FIT
Fecal Immunochemical Test
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases