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Completed

NCT Number: NCT01710215

Comparative Effectiveness of FIT, Colonoscopy, & Usual Care Screening Strategies

Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the US, though CRC death can be reduced by screening. However, there is uncertainty as to which screening strategy is most clinically and cost-effective from a population perspective where the aim is to optimize completion of the entire screening process continuum. Modeling studies suggest benefits and harms of colonoscopy and stool blood test strategies are similar, but generally assume 100% participation and subsequent clinically appropriate follow up--something never achieved in clinical practice. Comparative effectiveness studies of testing strategies, including comparisons of specific tests and approaches to optimizing effective test use, are necessary. Safety-net health systems care for populations at increased risk for adverse CRC outcomes, such as the uninsured and minorities, and have more limited resources. Therefore, safety-nets must resolve the uncertainty regarding the most effective screening strategy. The investigators will conduct a system-level, randomized comparative effectiveness trial of the benefits, harms, and costs of 3 screening strategies over 3 years, among 6000 patients age 50-64 years, who are not up-to-date with CRC screening, served by a large safety net health system. The three strategies studied will be: 1) Fecal immunochemical testing, with annual mailed invitation outreach (including a test kit), and a centralized process to promote participation and complete clinical follow up (FIT); 2) Colonoscopy, with annual mailed invitation outreach, and a centralized process to promote participation and complete clinical follow up (Colo); 3) Usual Care, with no mailed invitation outreach, and screening offered at primary care visits. The primary measure of benefit will be an outcome measure that summarizes patient-specific effective screening successes. The primary measure of harm will be screening non-participation. The primary measure of cost will be cost per-patient effectively screened. Our specific aims are to: 1) Compare benefits, harms, and costs of a FIT strategy versus a Colo strategy for CRC screening among patients not up-to-date with screening, and 2) Compare benefits, harms, and costs of a) the FIT strategy vs. Usual Care and b) the Colo strategy vs. Usual Care for CRC screening.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

50 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Parkland Health & Hospital System

Dallas, Texas, 75235, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females
  • Age 50-64 years
  • Seen one or more times at a Parkland primary care clinic within one year (Index Year)
  • Participants in Parkland's medical assistance program for the uninsured (Parkland Health Plus)
  • All races and ethnicities

Exclusion criteria

  • Up-to-date with CRC screening, defined by:
  • Colonoscopy in the last 10 years
  • Sigmoidoscopy in the last 5 years
  • Stool blood test (FIT) in the last year
  • Prior history of CRC, total colectomy, inflammatory bowel disease, or colon polyps
  • Address or phone number not on file
  • Incarcerated

Treatment and study plan

FIT Screening Strategy

Other
  • Mailed outreach invitation to complete FIT, including a test kit (1-sample FIT, simplified instructions on how to perform the test, and return mailer with prepaid postage).
  • Two "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.

Colon Screening Strategy

Other
  • Mailed outreach invitation to complete a colonoscopy, including a number to call to schedule a colonoscopy.
  • Two "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.

Primary outcomes

  1. Benefit: Proportion of patients achieving one of the effective screening "successes."

    Time frame: All outcomes will be adjudicated within 3 years.

    The primary benefit measure will be defined by the proportion of patients achieving an effective screening "success" defined as:

    • Invited to colonoscopy (i.e. colo), responded to invite, determined to be too sick to scope by phone triage and clinical review
    • Screening colo completed, no cancer detected
    • Screening colo completed, cancer detected, 1st cancer treatment consultation visit completed
    • FIT screening completed, test normal, FIT repeated annually for 2 years
    • FIT screening completed, test abnormal, failed phone triage for direct scheduling for colo, and after GI clinic visit, determined to be too sick to scope
    • FIT screening completed, test abnormal, failed phone triage and clinical review, GI clinic visit, determined to be scopable, colo completed
    • FIT screening completed, test abnormal, colo completed, no cancer detected
    • FIT screening completed, test abnormal, colo completed, cancer detected, 1st cancer treatment consultation visit completed

  2. Harm: Rate of screening non-participation.

    Time frame: All outcomes will be adjudicated within 3 years.

    The primary measure of harms will be the rate of non-screening because initial test completion is a basic prerequisite for prevention of adverse CRC outcomes by a screening process. It is a readily measurable, basic quality assessment. Processes associated with high rates of non-screening would be expected to result in poor long term CRC outcomes.

  3. Cost: Cost per-patient effectively screened.

    Time frame: All outcomes will be adjudicated within 3 years.

    The primary measure of costs will be the cost per-patient effectively screened from the health system perspective, with effective screening defined by the proportion of patients achieving an effective screening "success." Follow up time for cost-assessment will start at randomization and end either when a patient reaches an effective screening "success" endpoint, or at the end of the three year-follow up time. This outcome addresses a practical question most health systems will have in assessing our screening strategy: What is the strategy specific cost per-patient effectively screened?

Secondary outcomes

  1. Benefit: Number of CRCs, advanced adenomas, and adenomas detected.

    Time frame: All outcomes will be adjudicated within 3 years.

    Number of CRCs, advanced adenomas, and adenomas detected.

  2. Benefit: Number of patients screened.

    Time frame: All outcomes will be adjudicated within 3 years.

    Number of patients screened, defined by the proportion of patients completing one time FIT or colonoscopy.

  3. Harm: Number of CRCs diagnosed based on symptoms/signs rather than screening.

    Time frame: All outcomes will be adjudicated within 3 years.

    Number of CRCs diagnosed based on symptoms/signs rather than screening.

  4. Harm: Ineffective screening.

    Time frame: All outcomes will be adjudicated within 3 years.

    Not achieving an effective screening "success." See definition of effective screening "successes" above.

  5. Harm: Post-colonoscopy bleeding or perforation.

    Time frame: All outcomes will be adjudicated within 3 years.

    Post-colonoscopy bleeding or perforation.

  6. Harm: Failed colonoscopy due to incomplete bowel prep or inability to reach cecum.

    Time frame: All outcomes will be adjudicated within 3 years.

    Failed colonoscopy due to incomplete bowel prep or inability to reach cecum.

  7. Cost: Cost per patient screened.

    Time frame: All outcomes will be adjudicated within 3 years.

    Cost per patient screened.

  8. Cost: Incremental costs for the FIT and Colo strategies relative to the Usual Care strategy.

    Time frame: All outcomes will be adjudicated within 3 years.

    Incremental costs for the FIT and Colo strategies relative to the Usual Care strategy.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)
  • Parkland Health and Hospital System

Registry information

Official study title

Parkland-UT Southwestern PROSPR Center: Colon Cancer Screening in a Safety Net: Comparative Effectiveness of FIT, Colonoscopy, & Usual Care Screening Strategies

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 19, 2012
Registry last updated
Apr 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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