Adherence to Colon Cancer Screening (ACCS)

NCT02112747 | Completed DMC

• 2 other identifiers: OSU-12230NCI-2013-01146
• Study Type: interventional
• Target: 1,900
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer; Rectal Cancer

Keywords

Colorectal Cancer Prevention; Colorectal Cancer Screening; ACCS; Lynch Syndrome; LS

Outcome Measures

Primary Outcomes (1)

• Successfully following screening guidelines appropriate to the participant's risk profile

  For participants who are within the recommended guidelines, success would be defined as receiving no further screening. For those outside of the recommended guidelines, success would entail receiving a screening test. The outcome will combine medical record review and self-report by using medical record review when available and self-report otherwise. Evaluations will use a generalized estimating equations (GEE) approach with empirical sandwich variance estimators.

  Up to 14 months

Secondary Outcomes (1)

• Cost effectiveness of the interventions

  Up to 14 months

Study Arms (4)

Arm 1: website access only

NO INTERVENTION

There is no intervention with this arm. Completion of the website is part of enrollment.

Arm 2: patient navigator

EXPERIMENTAL

The intervention consists of participants receiving the services of a patient navigator to address individual barriers to adhering to the "personal prescription" for colon and rectal cancer screening.

Other: Patient Navigator

Arm 3: genetic counseling

NO INTERVENTION

There is no intervention in this arm. Patients diagnosed as positive for Lynch Syndrome use genetic counseling to discuss medical and family history and genetic risk of CRC, including genetic factors such as DNA mismatch repair genes, autosomal dominant inheritance, cancer risks associated with LS, screening recommendations, and genetic testing. There is no intervention. This is standard care.

Arm 4:Gen. counselor & patient navigator

EXPERIMENTAL

Participants diagnosed positive for Lynch syndrome use genetic counseling as in Arm 3 and in addition receive the services of a patient navigator to address individual barriers to adhering to the CRC screening recommendations.

Other: Patient Navigator

Interventions

Patient Navigator OTHER

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.

Arm 2: patient navigator; Arm 4:Gen. counselor & patient navigator

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant women
• Prisoners
• Individuals who are cognitively impaired

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• 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.

  PMID: 31666284 DERIVED

Related Links

• The Jamesline

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms; Colorectal Neoplasms, Hereditary Nonpolyposis

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Electra Paskett

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 10, 2014
• First Posted: April 14, 2014
• Study Start: September 1, 2013
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)