Comparing Interventions to Increase Colorectal Cancer Screening
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to test different approaches to help people understand the
      purpose of colorectal cancer (CRC) screening, two screening test options available, and the
      barriers to screening so they can make informed decisions about CRC screening. Participants
      will be randomly assigned to one of three groups: (1) one group will receive a tailored
      digital video disc (DVD) in the mail; (2) another group will receive the mailed DVD plus
      telephone calls from a patient navigator; and (3) the third group will receive the care
      normally provided by the healthcare system's endoscopy department.

      The investigators hypothesize the following: (1) participants who receive the tailored DVD
      plus the patient navigation intervention will have higher rates of CRC screening with the
      fecal immunochemical test (FIT), colonoscopy, or either screening test compared to those who
      receive the tailored DVD alone; (2) participants who receive either intervention (DVD only or
      DVD plus patient navigation) will have higher rates of CRC screening with FIT, colonoscopy,
      or either screening test than those who receive usual care; and (3) participants who receive
      either intervention who complete colonoscopy will have better quality of bowel preparation,
      less anxiety about the procedure, and greater satisfaction with the colonoscopy experience
      than those who receive usual care.
    

Detailed description: 
      Colorectal cancer (CRC) often can be prevented through regular screening and although
      multiple screening tests are available, colonoscopy is often the only screening test offered
      to patients. Unfortunately, up to half of people in some hospitals who receive a
      recommendation and are scheduled for colonoscopy do not complete the test. Reasons for not
      completing colonoscopy include lack of awareness of the need for, and benefits of, screening,
      fear of pain, fear of finding cancer, unpleasantness of the bowel preparation, cost,
      transportation issues, and the unwillingness to undergo an invasive test in the absence of
      symptoms. The process of bowel cleansing is one of the most challenging aspects of having a
      colonoscopy. Interventions that improve patients' knowledge about CRC screening, including
      test options other than colonoscopy, enhance access, improve skills needed to complete CRC
      screening, and reduce barriers will lead to greater numbers of people being screened. Patient
      navigation and computer tailored interventions have been shown to be effective approaches to
      increase CRC and other cancer screening but there is no evidence of their comparative
      effectiveness. The purpose of this study is to compare two health system-based interventions,
      with one another and with usual care, to increase completion rates among a diverse sample of
      patients. The investigators will enroll an ethnically diverse group of 450 men and women aged
      50-75,or aged 45-75 if African American, who are at average risk for CRC and were referred
      and scheduled for colonoscopy at one endoscopy department but canceled or did not attend
      their scheduled appointment. Participants will be randomized to receive: (1) a mailed
      tailored digital video disc (DVD) alone; 2) the mailed tailored DVD plus a telephone-based
      Patient Navigator; or 3) usual care. Data will be collected at baseline, at 6 months and at 9
      months post-baseline. Interviews to assess receipt, viewing, and satisfaction with the
      tailored DVD will be conducted 2 weeks after mailing. Satisfaction with the patient navigator
      will be assessed at 6 months. Multivariable logistic regression analyses will be used to test
      the interventions' effects on CRC screening test completion and, for those who complete
      colonoscopy, quality of bowel preparation. The investigators will also examine whether these
      interventions change knowledge about CRC and screening as well as health beliefs (perceived
      risk, perceived benefits, barriers, and self-efficacy) about screening. From this study, the
      investigators will learn how effective these two standardized, easy to disseminate health
      system-based interventions are compared to each other and to usual care. If the interventions
      are found to be equally effective, or differentially effective for different subgroups of
      patients, healthcare systems may consider implementing one or both of these interventions in
      their settings.
    

Intervention name(s): Tailored DVD; Patient Navigation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A 20 minute tailored DVD titled "Approaches to Colon Testing" is viewed by participants. It is designed to encourage CRC screening uptake by colonoscopy or FIT by increasing the participant's CRC knowledge and beliefs about the benefits of screening, reducing barriers to screening, and increasing self-efficacy for screening by demonstrating how these tests are performed.; Participants talk by telephone with a Patient Navigator who is a trained nurse. The Patient Navigator determines if participants viewed the tailored DVD and answers any questions about the content. The Patient Navigator then provides telephone counseling on CRC and screening tests to: (1) increase knowledge, perceived benefits, and self-efficacy; (2) reduce barriers; (3) enhance access; and (4) provide social support.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Cancer Screening Tests; Colonoscopy