Clinical trial NCT02112747: Adherence to Colon Cancer Screening (ACCS)
Official title: Ohio Colorectal Cancer Prevention Initiative: Adherence to Colon Cancer Screening (ACCS) Project:Your Personal Prescription For Colorectal Cancer Screening.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Rectal Cancer
Keywords: Colorectal Cancer Prevention
Colorectal Cancer Screening
ACCS
Lynch Syndrome
LS
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2014-04-14
Enrollment: 1900
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Successfully following screening guidelines appropriate to the participant's risk profile
timeFrame: Up to 14 months
Secondary outcomes:
measure: Cost effectiveness of the interventions
timeFrame: Up to 14 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Electra Paskett
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paskett ED, Bernardo BM, Young GS, Katz ML, Reiter PL, Tatum CM, Oliveri JM, DeGraffinreid CR, Gray DM, Pearlman R, Hampel H. Comparative Effectiveness of Two Interventions to Increase Colorectal Cancer Screening for Those at Increased Risk Based on Family History: Results of a Randomized Trial. Cancer Epidemiol Biomarkers Prev. 2020 Jan;29(1):3-9. doi: 10.1158/1055-9965.EPI-19-0797. Epub 2019 Oct 30.