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Adherence to Colon Cancer Screening (ACCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02112747
Recruitment Status : Active, not recruiting
First Posted : April 14, 2014
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Electra Paskett, Ohio State University Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE April 10, 2014
First Posted Date  ICMJE April 14, 2014
Last Update Posted Date August 2, 2019
Study Start Date  ICMJE September 2013
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2014)
Successfully following screening guidelines appropriate to the participant's risk profile [ Time Frame: Up to 14 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2014)
Cost effectiveness of the interventions [ Time Frame: Up to 14 months ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adherence to Colon Cancer Screening (ACCS)
Official Title  ICMJE Ohio Colorectal Cancer Prevention Initiative: Adherence to Colon Cancer Screening (ACCS) Project:Your Personal Prescription For Colorectal Cancer Screening.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Colon Cancer
  • Rectal Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Patient Navigator
  • 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.
    Intervention: Other: Patient Navigator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 13, 2017)
1900
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2014)
12000
Estimated Study Completion Date  ICMJE December 31, 2020
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02112747
Other Study ID Numbers  ICMJE OSU-12230
NCI-2013-01146 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Electra Paskett, Ohio State University Comprehensive Cancer Center
Study Sponsor  ICMJE Ohio State University Comprehensive Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Electra Paskett Ohio State University Comprehensive Cancer Center
PRS Account Ohio State University Comprehensive Cancer Center
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP