Facilitating Informed Decisions for MSI Testing
- 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.
- 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
- 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.
Intervention Model: Single Group Assignment, Masking: Open Label
Impact of standard informed consent vs CD-ROM educational intervention on knowledge about microsatellite instability (MSI) testing
Participants completed a baseline survey upon enrollment to the trial. 2 weeks after baseline, they completed a follow-up survey (assessed at both baseline and FU).
at enrollment and 2 weeks after enrollment
Sharon Manne, PhD
Fox Chase Cancer Center
United States: Food and Drug Administration
|Fox Chase Cancer Center - Philadelphia||Philadelphia, Pennsylvania 19111-2497|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Helen F. Graham Cancer Center at Christiana Hospital||Newark, Delaware 19718|