Facilitating Informed Decisions for MSI Testing
21 Years
N/A
Both
Colorectal Cancer, Hereditary Non-polyposis Colon Cancer
Trial Information
Facilitating Informed Decisions for MSI Testing
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
Impact of standard informed consent vs CD-ROM educational intervention on knowledge about microsatellite instability (MSI) testing
Outcome Description:
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).
Outcome Time Frame:
at enrollment and 2 weeks after enrollment
Safety Issue:
No
Principal Investigator
Sharon Manne, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fox Chase Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000443988
NCT ID:
NCT00450424
Start Date:
June 2007
Completion Date:
Related Keywords:
- Colorectal Cancer
- Hereditary Non-polyposis Colon Cancer
- colon cancer
- rectal cancer
- hereditary non-polyposis colon cancer
- recurrent colon cancer
- stage I colon cancer
- stage IIA colon cancer
- stage IIB colon cancer
- stage IIIA colon cancer
- stage IIIB colon cancer
- stage IIIC colon cancer
- stage IVA colon cancer
- stage IVB colon cancer
- recurrent rectal cancer
- stage I rectal cancer
- stage IIA rectal cancer
- stage IIB rectal cancer
- stage IIC rectal cancer
- stage IIIA rectal cancer
- stage IIIB rectal cancer
- stage IIIC rectal cancer
- stage IVA rectal cancer
- stage IVB rectal cancer
- Colonic Neoplasms
- Colorectal Neoplasms
- Colorectal Neoplasms, Hereditary Nonpolyposis
Name | Location |
|---|---|
| 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 |
