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

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.

DISEASE CHARACTERISTICS:

- 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