Trial record 2 of 5 for:    rectal cancer | Open Studies | Interventional Studies | United States, Ohio | Other

Adherence to Colon Cancer Screening (ACCS)

This study is currently recruiting participants.
Verified April 2014 by Ohio State University Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Electra Paskett, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT02112747
First received: April 10, 2014
Last updated: NA
Last verified: April 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Colon Cancer
Rectal Cancer
Other: Patient Navigator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Ohio Colorectal Cancer Prevention Initiative: Adherence to Colon Cancer Screening (ACCS) Project:Your Personal Prescription For Colorectal Cancer Screening.

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Successfully following screening guidelines appropriate to the participant's risk profile [ Time Frame: Up to 14 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Cost effectiveness of the interventions [ Time Frame: Up to 14 months ] [ Designated as safety issue: No ]
    Analysis will consist of a cost analysis of the intervention incorporating project expenditures and both financial and non-financial costs incurred by the project participants. Financial benefits from the project will be incorporated into the cost analysis to produce a net cost of the interventions. These financial benefits will include expenditures for unnecessary or "overscreening" prevented by the interventions. The results of the net cost analysis will be combined with the outcome measures for screening interventions to establish the cost per guideline concordant screening.


Estimated Enrollment: 12000
Study Start Date: September 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Arm 1: website access only
There is no intervention with this arm. Completion of the website is part of enrollment.
Experimental: Arm 2: patient navigator
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
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.
No Intervention: Arm 3: genetic counseling
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.
Experimental: Arm 4:Gen. counselor & patient navigator
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
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.

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 [LS] positive vs. LS 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, LS 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

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02112747

Contacts
Contact: The Ohio State University Comprehensive Cancer Center 1-800-293-5066 Jamesline@osumc.edu
Contact: Electra Paskett, PhD 614-293-3917 Electra.Paskett@osumc.edu

Locations
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Electra D. Paskett    614-293-3917    electra.paskett@osumc.edu   
Principal Investigator: Electra D. Paskett         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Electra Paskett Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Electra Paskett, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02112747     History of Changes
Other Study ID Numbers: OSU-12230, NCI-2013-01146
Study First Received: April 10, 2014
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
Colorectal Cancer Prevention
Colorectal Cancer Screening
ACCS
Lynch Syndrome
LS

Additional relevant MeSH terms:
Colonic Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Rectal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on April 15, 2014