- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00450424
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
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.
Study Overview
Status
Intervention / Treatment
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 (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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Delaware
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Newark, Delaware, United States, 19713
- Helen F. Graham Cancer Center at Christiana Hospital
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111-2497
- Fox Chase Cancer Center - Philadelphia
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Counseling
Participants will be given one of two counseling interventions regarding MSI testing: standard counseling or a CD-ROM intervention.
|
Participants in the Counseling intervention will meet with the study health educator who will provide the participant with the standard MSI informed consent form and provide a brief, standardized explanation of the MSI test.
At that time, the participant can ask any questions s/he wishes to ask.
The patients will either sign (or not sign, if they do not consent to have the test, or wish to think further about the decision) after this discussion.
Participants who have further questions will be referred to either the attending physician or the genetics counselor at each hospital site.
Participants who are randomized to the CD-ROM condition will complete the baseline interview and then meet with the health educator who will provide the participant with the standard MSI consent form and provide a brief, standardized explanation of the MSI test.
At that time, the participant can ask any questions s/he wishes to ask.
Next, the participant will be provided with the CD-ROM to view on a laptop computer in the clinic.
Participants will also be given a copy of the CD-ROM to take home and keep for future reference.
The CD-ROM patients will sign (or not sign, if they do not consent or wish to think further about the decision) the consent form after this discussion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of Standard Informed Consent vs CD-ROM Educational Intervention on Knowledge About Microsatellite Instability (MSI) Testing
Time Frame: 2 weeks after enrollment
|
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).
|
2 weeks after enrollment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: at enrollment and 2 weeks after enrollment
|
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).
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 were measured.
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at enrollment and 2 weeks after enrollment
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Impact of Demographic Factors, Disease/Family History Characteristics, Family Support, and Cancer-related Distress on Satisfaction With and Completeness of the Informed Consent Process
Time Frame: at enrollment and 2 weeks after enrollment
|
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).
Impact of demographic factors, disease/family history characteristics, family support, and cancer-related distress on satisfaction with and completeness of the informed consent process was measured
|
at enrollment and 2 weeks after enrollment
|
Patient Satisfaction With the Preparation to Make a Decision
Time Frame: at enrollment and 2 weeks after enrollment
|
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).
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at enrollment and 2 weeks after enrollment
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Manne 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.
- Hall 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- recurrent colon cancer
- recurrent rectal cancer
- rectal cancer
- colon cancer
- stage IIIB rectal cancer
- stage IIIC rectal cancer
- stage I rectal cancer
- stage I colon cancer
- stage IIA colon cancer
- stage IIB colon cancer
- stage IIIA colon cancer
- stage IIA rectal cancer
- stage IIB rectal cancer
- stage IIC rectal cancer
- stage IIIA rectal cancer
- stage IIIB colon cancer
- stage IIIC colon cancer
- stage IVA colon cancer
- stage IVB colon cancer
- stage IVA rectal cancer
- stage IVB rectal cancer
- hereditary non-polyposis colon cancer
Additional Relevant MeSH Terms
- Digestive System Diseases
- Metabolic Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Genetic Diseases, Inborn
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Neoplastic Syndromes, Hereditary
- DNA Repair-Deficiency Disorders
- Colorectal Neoplasms
- Colorectal Neoplasms, Hereditary Nonpolyposis
- Colonic Neoplasms
Other Study ID Numbers
- CDR0000443988
- 04827 (OTHER: Fox Chase Cancer Center)
- R01CA109332-05 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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