Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450424
Status:
COMPLETED
Last Update Posted:
2014-09-05
First Post:
2007-03-20
Brief Title:
Educational CD-ROM Compared With Standard Informed Consent for Patients With Colorectal Cancer or a Family History of Colorectal Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Facilitating Informed Decisions for MSI Testing
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 eg 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 diseasefamily 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
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 eg 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 diseasefamily 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01CA109332-05 | NIH | Fox Chase Cancer Center | httpsreporternihgovquickSearchR01CA109332-05 |
| 04827 | OTHER | None | None |