Clinical trial · Interventional
Educational CD-ROM Compared With Standard Informed Consent for Patients With Colorectal Cancer or a Family History of Colorectal Cancer
Facilitating Informed Decisions for MSI Testing
NCT00450424CI-TRIAL-00015545completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Hereditary Non-polyposis Colon Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD-ROM intervention | Other | — | UNRESOLVED |
| counseling intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- NO_INTERVENTION
- label
- Counseling
- description
- Participants will be given one of two counseling interventions regarding MSI testing: standard counseling or a CD-ROM intervention.
- interventionNames
- Other: counseling intervention
- Other: CD-ROM intervention
Primary outcomes (1)
- measure
- Impact of Standard Informed Consent vs CD-ROM Educational Intervention on Knowledge About Microsatellite Instability (MSI) Testing
- timeFrame
- 2 weeks after enrollment
- description
- 10-item true/false MSI knowledge survey developed by the oncologists on trial. (e.g., "Microsatellite Instability is found in every person that has had cancer."; "Microsatellite Instability may be caused by a permanent change in a gene that is inherited from a person's mother or father."). Participants can score anywhere from 0 (no questions answered correctly) to 10 (all questions answered correctly).
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTManne SL, Meropol NJ, Weinberg DS, Vig H, Ali-Khan Catts Z, Manning C, Ross E, Shannon K, Chung DC. Facilitating informed decisions regarding microsatellite instability testing among high-risk individuals diagnosed with colorectal cancer. J Clin Oncol. 2010 Mar 10;28(8):1366-72. doi: 10.1200/JCO.2009.25.0399. Epub 2010 Feb 8. PMID 20142594
- RESULTHall MJ, Manne SL, Winkel G, Chung DS, Weinberg DS, Meropol NJ. Effects of a decision support intervention on decisional conflict associated with microsatellite instability testing. Cancer Epidemiol Biomarkers Prev. 2011 Feb;20(2):249-54. doi: 10.1158/1055-9965.EPI-10-0685. Epub 2011 Jan 6. PMID 21212064