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Trial record 83 of 188 for:    colon cancer | ( Map: Texas, United States )

Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening

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ClinicalTrials.gov Identifier: NCT03414125
Recruitment Status : Recruiting
First Posted : January 29, 2018
Last Update Posted : May 2, 2019
Sponsor:
Collaborators:
Cancer Prevention Research Institute of Texas
Parkland Health & Hospital System
Information provided by (Responsible Party):
Amit Singal, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE January 22, 2018
First Posted Date  ICMJE January 29, 2018
Last Update Posted Date May 2, 2019
Actual Study Start Date  ICMJE September 7, 2018
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2018)
One-time Screening Completion [ Time Frame: Within one year of randomization ]
Proportion of patients who complete CRC screening with colonoscopy, sigmoidoscopy, or FIT
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2018)
Screening Up-to-date [ Time Frame: At 2 and 3 years post-randomization ]
Screening Up-to-date status
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening
Official Title  ICMJE Comparing the Effect of a Mailed Outreach Intervention Offering Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening Outcomes: A Pragmatic Randomized Control Trial in a Safety Net Health System
Brief Summary This is a pragmatic, randomized, controlled trial comparing whether a mailed outreach intervention offering patients who are not up-to-date with colorectal cancer (CRC) a choice of completing a home Fecal Immunochemical Test (FIT) test or scheduling a screening colonoscopy increases CRC screening completion compared to a mailed FIT kit outreach program (which does not offer an explicit choice of screening modality). The trial will be conducted in a racially and socioeconomically diverse cohort of patients served by an integrated safety net delivery system that has a "FIT first" population health screening strategy. All patients will also have access to whatever CRC screening is recommended through usual visit-based care.
Detailed Description Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the US, though CRC death can be reduced by screening. In the NCI-funded UT Southwestern-Parkland PROSPR Center (U54 CA163308), mailed FIT-based outreach doubled the proportion of patients up-to-date with screening compared to usual care. Investigators are now conducting a comparative effectiveness trial to evaluate the effect of a mailed invite offering a choice of FIT or colonoscopy (n=2,000) on one-time CRC screening completion compared to mailed FIT-based outreach (which does not offer an explicit choice of screening modality (n=8,000.) Randomization will be stratified based on whether or not patients completed a FIT within the prior 18-month period. Patients randomized to FIT outreach will receive: a) low-literacy educational letters, b) mailed screening outreach invitations, c) a one-sample home FIT kit and return mailer with prepaid postage, d) telephone reminder calls including one-on-one education, and e) centralized patient navigation for follow-up of abnormal screening results, and treatment for patients newly diagnosed with CRC. Patients randomized to the "choice" arm will receive the same materials described above; however, the educational letter will explain and offer the additional choice of screening by colonoscopy (instead of completing the mailed FIT kit). The mailing will include a low health literacy one-page option grid outlining the pros and cons of FIT vs. colonoscopy. We will not recommend a particular test as preferred but instead emphasize that both are good choices, and the patient should choose the screening option that seems right for them. Patients choosing colonoscopy will be provided a telephone number to schedule the procedure. During scheduling, patients will be triaged by study staff with a structured history and physical form to "direct access" colonoscopy or a pre-colonoscopy clinic visit. Patients choosing FIT can return the one-sample mailed FIT kit using the return envelope with prepaid postage.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Evaluate effect of offering choice of FIT or colonoscopy (n=2,000) compared to FIT alone (n=8,000) on one-time CRC screening completion, repeat screening, and follow-up of abnormal FIT results.
Masking: Single (Outcomes Assessor)
Masking Description:
Single Blind
Primary Purpose: Screening
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Other: FIT Screening Strategy

    Mailed outreach invitation to complete FIT. FIT Strategy invitation includes: 1) invitation letter, 2) test kit (1-sample FIT, simplified instructions on how to perform the test and return mailer with prepaid postage).

    Up to three "live" phone reminders from project staff 2 to 3 weeks after the invitation to encourage screening completion.

    Centralized processes to promote guideline-based follow-up.

  • Other: Choice Screening Strategy

    Mailed outreach invitation offering patients the choice to complete either a FIT or schedule a colonoscopy.

    Letter will discuss advantages and disadvantages of FIT vs. colonoscopy but will not recommend a particular test, allowing patients to choose a screening option based on their own preferences. Outreach includes: 1) invitation letter, 2) choice grid 3) telephone number for scheduling colonoscopy, and 4) test kit (1-sample FIT, simplified instructions on how to perform the test and return mailer with prepaid postage).

    Up to three "live" phone call reminders from project staff 2 to 3 weeks after the mailed invitation to encourage screening completion.

    Centralized processes to promote guideline-based follow-up.

Study Arms  ICMJE
  • Active Comparator: FIT Screening Strategy

    Mailed outreach invitation to complete FIT. FIT Strategy invitation includes: 1) invitation letter, 2) test kit (1-sample FIT, simplified instructions on how to perform the test and return mailer with prepaid postage).

    Up to three "live" phone reminders from project staff 2 to 3 weeks after the invitation to encourage screening completion.

    Centralized processes to promote guideline-based follow-up.

    Intervention: Other: FIT Screening Strategy
  • Experimental: Choice Screening Strategy

    Mailed outreach invitation offering patients the choice to complete either a FIT or schedule a colonoscopy.

    Letter will discuss advantages and disadvantages of FIT vs. colonoscopy but will not recommend a particular test, allowing patients to choose a screening option based on their own preferences.

    Choice Strategy outreach invitation includes: 1) invitation letter, 2) option grid comparing FIT and colonoscopy 3) telephone number for scheduling colonoscopy, and 4) test kit (1-sample FIT, simplified instructions on how to perform the test and return mailer with prepaid postage).

    Up to three "live" phone call reminders from project staff 2 to 3 weeks after the mailed invitation to encourage screening completion.

    Centralized processes to promote guideline-based follow-up.

    Intervention: Other: Choice Screening Strategy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 22, 2018)
10000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males and females
  • Age 50-63 years
  • Seen at least one time at a Parkland primary care clinic within one year prior to randomization
  • Participants in Parkland's medical assistance program for the uninsured (Parkland Financial Assistance)
  • All races and ethnicities

Exclusion Criteria:

  • Up-to-date with CRC screening, defined by:

    1. Colonoscopy in the last 10 years
    2. Sigmoidoscopy in the last 5 years
  • Prior history of CRC, total colectomy, inflammatory bowel disease, or colon polyps
  • Address or phone number not on file
  • Incarcerated
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 63 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lisa Quirk 214-648-9703 lisa.quirk@utsouthwestern.edu
Contact: Amit Singal, MD, MS 214-645-6111 amit.singal@utsouthwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03414125
Other Study ID Numbers  ICMJE STU 082016-060
21985 ( Other Identifier: UTSouthwestern - Velos )
PP160075 ( Other Grant/Funding Number: Cancer Prevention and Research Institute of Texas )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Amit Singal, University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE
  • Cancer Prevention Research Institute of Texas
  • Parkland Health & Hospital System
Investigators  ICMJE
Principal Investigator: Amit Singal, MD, MS UT Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP