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

Temple University Health System (TUHS)

Status: Completed

Conditions: Hereditary Non-polyposis Colon Cancer; Colorectal Cancer

Treatments: Other: CD-ROM intervention; Other: counseling intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00450424

04827 (Other Identifier)

R01CA109332-05 (U.S. NIH Grant/Contract)

CDR0000443988

Details and patient eligibility

About

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.

Full 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.

Enrollment: 239 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

239 participants in 1 patient group

Counseling

No Intervention group

Description:

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

Treatment:

Other: counseling intervention

Other: CD-ROM intervention