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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00450424
First received: March 20, 2007
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Colorectal Cancer
Hereditary Non-polyposis Colon Cancer
Other: counseling intervention
Other: CD-ROM intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Facilitating Informed Decisions for MSI Testing

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:
  • Impact of Standard Informed Consent vs CD-ROM Educational Intervention on Knowledge About Microsatellite Instability (MSI) Testing [ Time Frame: 2 weeks after enrollment ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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

  • Patient Satisfaction With the Preparation to Make a Decision [ Time Frame: at enrollment and 2 weeks after enrollment ] [ Designated as safety issue: No ]
    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).


Enrollment: 239
Study Start Date: June 2007
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Counseling
Participants will be given one of two counseling interventions regarding MSI testing: standard counseling or a CD-ROM intervention.
Other: counseling 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.
Other: CD-ROM intervention
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00450424

Locations
United States, Delaware
Helen F. Graham Cancer Center at Christiana Hospital
Newark, Delaware, United States, 19713
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
Principal Investigator: Sharon Manne, PhD Fox Chase Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00450424     History of Changes
Other Study ID Numbers: CDR0000443988, 04827, R01CA109332-05
Study First Received: March 20, 2007
Results First Received: August 5, 2014
Last Updated: September 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Fox Chase Cancer Center:
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

Additional relevant MeSH terms:
Colorectal Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
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
DNA Repair-Deficiency Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 19, 2014