Educational CD-ROM Compared With Standard Informed Consent for Patients With Colorectal Cancer or a Family History of Colorectal Cancer

NCT00450424 | Completed Results

• 3 other identifiers: CDR000044398804827R01CA109332-05
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 3

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.

Conditions

Colorectal Cancer; Hereditary Non-polyposis Colon Cancer

Keywords

colon cancer; rectal cancer; hereditary non-polyposis colon cancer; recurrent colon cancer; stage I colon cancer; stage IIA colon cancer; stage IIB colon cancer; stage IIIA colon cancer; stage IIIB colon cancer; stage IIIC colon cancer; stage IVA colon cancer; stage IVB colon cancer; recurrent rectal cancer; stage I rectal cancer; stage IIA rectal cancer; stage IIB rectal cancer; stage IIC rectal cancer; stage IIIA rectal cancer; stage IIIB rectal cancer; stage IIIC rectal cancer; stage IVA rectal cancer; stage IVB rectal cancer

Outcome Measures

Primary Outcomes (1)

• Impact of Standard Informed Consent vs CD-ROM Educational Intervention on Knowledge About Microsatellite Instability (MSI) Testing

  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

Secondary Outcomes (3)

• 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

  at enrollment and 2 weeks after enrollment

• Impact of Demographic Factors, Disease/Family History Characteristics, Family Support, and Cancer-related Distress on Satisfaction With and Completeness of the Informed Consent Process

  at enrollment and 2 weeks after enrollment

• Patient Satisfaction With the Preparation to Make a Decision

  at enrollment and 2 weeks after enrollment

Study Arms (1)

Counseling

NO INTERVENTION

Participants will be given one of two counseling interventions regarding MSI testing: standard counseling or a CD-ROM intervention.

Other: counseling intervention; Other: CD-ROM intervention

Interventions

counseling intervention OTHER

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.

Counseling

CD-ROM intervention OTHER

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.

Counseling

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Helen F. Graham Cancer Center at Christiana Hospital

Newark, Delaware, 19713, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Related Publications (2)

• 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.

  PMID: 20142594 RESULT

• 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.

  PMID: 21212064 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Colorectal Neoplasms, Hereditary Nonpolyposis; Colonic Neoplasms; Rectal Neoplasms

Interventions

Counseling

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Kristen Sorice
• Organization: Fox Chase Cancer Center

Kristen.Sorice@fccc.edu

215-214-1433

Study Officials

• Sharon Manne, PhD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2007
• First Posted: March 22, 2007
• Study Start: June 1, 2007
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: September 5, 2014
• Results First Posted: September 5, 2014

Record last verified: 2014-09

Locations

US (3)