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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase I/II Randomized Pilot Study of CD-ROM Education Versus Standard Informed Consent for Patients With Colorectal Cancer or a Family History of Colorectal Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Biomarker/Laboratory analysis, Educational/Counseling/Training, Screening Active 21 and over NCI FCCC-04827 NCT00450424

Trial Description

Purpose:

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.

This randomized phase I/II 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.

Eligibility:

Eligibility criteria include the following:

• At least 21 years old
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Some patients will receive an educational CD-ROM and will give feedback on the information it provides and its usefulness.

Other patients will be randomly assigned (have an equal chance of being placed) to one of two groups.

Patients in group one will be interviewed. They will also receive an informed consent for MSI testing and a standard explanation about the test.

Patients in group two will be interviewed. They will also receive an informed consent for MSI testing, and an educational CD-ROM that explains the test.

Patients in groups one and two will fill out a survey at 2 weeks.

Patients will undergo tissue sample collection for genetic testing.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Fox Chase Cancer Center - Philadelphia

Sharon Manne, PhD, Principal investigator		Ph: 215-728-5523; 888-369-2427 Email: sharon.manne@fccc.edu

U.S.A.
Delaware
	Newark
	Helen F. Graham Cancer Center at Christiana Hospital
		Clinical Trials Office - Helen F. Graham Cancer Center	Ph:  302-733-6227
Massachusetts
	Boston
	Massachusetts General Hospital
		Clinical Trials Office - Massachusetts General Hospital	Ph:  877-726-5130
Pennsylvania
	Philadelphia
	Fox Chase Cancer Center - Philadelphia
		Clinical Trials Office - Fox Chase Cancer Center - Philadelphia	Ph:  215-728-4790

Registry Information
Official Title		Facilitating Informed Decisions for MSI Testing
Trial Start Date		2005-06-15
Registered in ClinicalTrials.gov		NCT00450424
Date Submitted to PDQ		2005-08-10
Information Last Verified		2007-06-08
NCI Grant/Contract Number		CA06927, CA109332