Colorectal Cancer, Hereditary Non-polyposis Colon Cancer
Conditions
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
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.
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.
Interventions
OTHERcounseling 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.
OTHERCD-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.
Sponsors
National Cancer Institute (NCI)
Fox Chase Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of Standard Informed Consent vs CD-ROM Educational Intervention on Knowledge About Microsatellite Instability (MSI) Testing | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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 |
| Patient Satisfaction With the Preparation to Make a Decision | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Consent Condition Participants in the Standard consent condition will complete the baseline interview and then 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. | 117 |
| CD-ROM Condition 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. | 122 |
| Total | 239 |
Baseline characteristics
| Characteristic | Standard Consent Condition | CD-ROM Condition | Total |
|---|---|---|---|
| Age, Continuous | 45.69 years STANDARD_DEVIATION 7.38 | 47.33 years STANDARD_DEVIATION 8.58 | 46.53 years STANDARD_DEVIATION 8.04 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 114 Participants | 120 Participants | 234 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 4 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) White | 102 Participants | 112 Participants | 214 Participants |
| Sex: Female, Male Female | 57 Participants | 52 Participants | 109 Participants |
| Sex: Female, Male Male | 60 Participants | 70 Participants | 130 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 117 | 0 / 122 |
| serious Total, serious adverse events | 0 / 117 | 0 / 122 |
Outcome results
Primary
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).
Time frame: 2 weeks after enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Consent Condition | Impact of Standard Informed Consent vs CD-ROM Educational Intervention on Knowledge About Microsatellite Instability (MSI) Testing | 4.07 units on a scale | Standard Deviation 2.25 |
| CD-ROM Condition | Impact of Standard Informed Consent vs CD-ROM Educational Intervention on Knowledge About Microsatellite Instability (MSI) Testing | 4.17 units on a scale | Standard Deviation 2.94 |
Secondary
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
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.
Time frame: at enrollment and 2 weeks after enrollment
Secondary
Impact of Demographic Factors, Disease/Family History Characteristics, Family Support, and Cancer-related Distress on Satisfaction With and Completeness of the Informed Consent Process
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
Time frame: at enrollment and 2 weeks after enrollment
Secondary
Patient Satisfaction With the Preparation to Make a Decision
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).
Time frame: at enrollment and 2 weeks after enrollment