Adherence to Colon Cancer Screening (ACCS)
Condition: Colon Cancer; Rectal Cancer
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      This randomized clinical trial studies website access or genetic counseling with or without
      patient navigators on adherence to colorectal cancer screening recommendations in patients
      with newly diagnosed colorectal cancer and their first degree relatives. Websites for
      colorectal cancer prevention and genetic counseling may be effective methods to help people
      learn about cancer screening. Patient navigators may improve adherence to colorectal cancer
      screening recommendations. It is not yet known whether website access or genetic counseling
      is more effective with or without patient navigators.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Test the comparative-effectiveness of the interventions (i.e., website +/- navigator or
      genetic counseling +/- navigator) in a randomized controlled trial, using colorectal cancer
      (CRC) cases as the unit of randomization/analysis on adherence to individualized CRC
      screening recommendations.

      SECONDARY OBJECTIVES:

      I. Examine the cost effectiveness of the interventions, assessing the effect of the
      interventions on subgroups (i.e., Lynch syndrome positive vs. Lynch syndrome negative;
      probands vs. relatives; older vs. younger patients, etc), and barriers to adherence, as well
      as how the navigators resolve barriers.

      II. Overscreening will be explored.

      OUTLINE: Participants are assigned to 1 of 2 study components based on LS status. Within each
      component, participants are randomized to 1 of 2 arms.

      COMPONENT #1 (Lynch Negative Proband and their first degree relatives (FDRs):

      ARM I: Participants access a website to deliver a "personalized prescription for CRC
      prevention" based on age, Lynch Syndrome status, cancer history, age of 1st degree relative
      with CRC, and personal CRC screening history.

      ARM II: Participants access a website as in Arm I and receive the services of a patient
      navigator to address individual barriers to adhering to the "personal prescription" within 1
      month.

      COMPONENT #2 (Lynch Positive Proband and their FDRs):

      ARM III (Lynch positive proband): Participants use genetic counseling to discuss medical and
      family history and genetic risk of CRC, including genetic factors such as deoxyribonucleic
      acid (DNA) mismatch repair genes, autosomal dominant inheritance, cancer risks associated
      with LS, screening recommendations, and genetic testing.

      ARM IV (Lynch positive proband): Participants use genetic counseling as in Arm III and
      receive the services of a patient navigator to address individual barriers to adhering to the
      CRC screening recommendations within 1 month.

      After completion of study treatment, patients are followed up at 12-14 months.
    

Intervention name(s): Patient Navigator
Intervention type(s): Other
Intervention description(s): Patients are randomized to receive the assistance of a patient navigator to understand, obtain assistance with following the screening recommendations of the personal prescription given to them by the website survey.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Colorectal Cancer Prevention; Colorectal Cancer Screening; ACCS; Lynch Syndrome; LS