Patient case: 68-year-old male with colon cancer; genetic feature: MLH1 methylation suppression (microsatellite instability)

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

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.

Detailed 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.

Eligibility: Patient or family member meeting 1 of the following revised Bethesda colorectal cancer (CRC) criteria:
  -  Diagnosis of colon or rectal cancer at < 50 years of age
  -  Diagnosis of > 1 CRC at one time in the past
  -  Diagnosis of ≥ 1 CRC at different times
  -  Diagnosis of CRC and any other hereditary nonpolyposis colorectal cancer (HNPCC)-related cancers
  -  Diagnosis of CRC in ≥ 2 first-degree or second-degree relatives with HNPCC-related tumor and ≥ 1 cancer diagnosed at < 50 years of age
  -  Diagnosis of CRC in ≥ 2 first- or second-degree relatives with HNPCC-related tumors, regardless of age
  -  Diagnosis of CRC with pathologic features suggestive of microsatellite instability (MSI) and < 60 years of age
  -  Patients with CRC meeting the Amsterdam criteria defined below are ineligible:
  -  Three relatives with CRC with 1 being a first-degree relative of the other 2
  -  Cases that span ≥ 2 generations
  -  At least 1 CRC case diagnosed before 50 years of age
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant