Educational CD-ROM Compared With Standard Informed Consent for Patients With Colorectal Cancer or a Family History of Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title: Facilitating Informed Decisions for MSI Testing

Status Completed

Clinical Trial Summary

RATIONALE: The use of a CD-ROM may help patients with colorectal cancer or a family history of colorectal cancer make informed decisions about undergoing microsatellite instability (MSI) testing.

PURPOSE: This randomized clinical trial is studying an educational CD-ROM to see how well it works compared with standard informed consent to assist decision-making about MSI testing in patients with colorectal cancer or a family history of colorectal cancer.

Clinical Trial Description

OBJECTIVES:

Primary

• Compare the impact of standard informed consent vs a CD-ROM educational intervention on knowledge about microsatellite instability (MSI) testing in patients with colorectal cancer (CRC) or a family history of CRC.

• Determine the impact of these interventions on patient satisfaction with the preparation to make a decision.

Secondary

• Determine whether the CD-ROM educational intervention has a differential impact on satisfaction with the MSI test decision, difficulty making the MSI test decision, and decisional conflict, as well as on patients' attitudes about MSI testing and CRC (e.g., perceived benefits and barriers to having the MSI test, perceived risk for colorectal and related cancers, self-efficacy), on general and cancer-related distress, and on discussions with family members about the MSI test and familial CRC risk.

• Assess whether demographic factors, disease/family history characteristics, family support for testing, and cancer-related distress moderate the impact of the intervention on satisfaction with and completeness of the informed consent process.

OUTLINE: This is a multicenter, pilot, study (part I) followed by a randomized study (part II).

• Part I: The educational CD-ROM is developed over 9 months. Patients receive a pilot version of the CD-ROM and provide feedback regarding usability and content.

• Part II: Patients are randomized to 1 of 2 arms.

• Arm I: Patients complete a baseline interview and receive a standard informed consent for microsatellite instability (MSI) testing and a brief, standardized explanation of the MSI test.

• Arm II: Patients complete a baseline interview and receive a standard informed consent for MSI testing and the educational CD-ROM developed in phase I.

All patients in part II (even those that did not consent to the MSI test) complete a follow-up survey at 2 weeks.

Tissue samples from patients are analyzed by immunohistochemistry and MSI assay (polymerase chain reaction) for MLH1 and MSH2.

PROJECTED ACCRUAL: A total of 184 patients will be accrued for this study. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Colorectal Neoplasms, Hereditary Nonpolyposis
• Hereditary Non-polyposis Colon Cancer

• NCT number: NCT00450424
• Study type: Interventional
• Source: Fox Chase Cancer Center
• Status: Completed
• Phase: N/A
• Start date: June 2007
• Completion date: November 2011