N/A
N=239
Educational CD-ROM Compared With Standard Informed Consent for Patients With Colorectal Cancer or a Family History of Colorectal Cancer
Colorectal Cancer · Hereditary Non-polyposis Colon Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00450424 ↗Enrolled (actual)
239
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Impact of Standard Informed Consent vs CD-ROM Educational Intervention on Knowledge About Microsatellite Instability (MSI) Testing — 4.07; 4.17 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- counseling intervention (Other); CD-ROM intervention (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Fox Chase Cancer Center
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Impact of Standard Informed Consent vs CD-ROM Educational Intervention on Knowledge About Microsatellite Instability (MSI) Testing |
4.07; 4.17 | — |
| SECONDARY Differential Impact of CD-ROM on Satisfaction With MSI Test Decision, Difficulty Making Decision & Decisional Conflict; Attitude; General & Cancer-related Distress; Discussions With Family About MSI Test & Familial Colorectal Cancer Risk |
— | — |
| SECONDARY Impact of Demographic Factors, Disease/Family History Characteristics, Family Support, and Cancer-related Distress on Satisfaction With and Completeness of the Informed Consent Process |
— | — |
| SECONDARY Patient Satisfaction With the Preparation to Make a Decision |
— | — |
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.
Eligibility Criteria
Patient or family member meeting 1 of the following revised Bethesda colorectal cancer (CRC) criteria:
- Diagnosis of colon or rectal cancer at 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
Data sourced from ClinicalTrials.gov (NCT00450424). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.