Adherence to Colon Cancer Screening (ACCS)

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.

Inclusion Criteria:

- Newly diagnosed with colorectal adenocarcinoma at Ohio State University (OSU) (or a
participating Ohio hospital) with sufficient tumor available to perform the
microsatellite instability (MSI) test, regardless of age at diagnosis or family
history

- First-degree relatives of the cases who test positive for LS

- First-degree relatives of the cases who test negative for LS

Exclusion Criteria:

- Pregnant women

- Prisoners

- Individuals who are cognitively impaired