Trial Outcomes & Findings for Educational CD-ROM Compared With Standard Informed Consent for Patients With Colorectal Cancer or a Family History of Colorectal Cancer (NCT NCT00450424)

Last Updated: 2014-09-05

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

239 participants

Primary outcome timeframe

2 weeks after enrollment

Results posted on

2014-09-05

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	122	117
Overall Study COMPLETED	102	106
Overall Study NOT COMPLETED	20	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Consent Condition n=117 Participants 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.	CD-ROM Condition n=122 Participants 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.	Total n=239 Participants Total of all reporting groups
Age, Continuous	45.69 years STANDARD_DEVIATION 7.38 • n=5 Participants	47.33 years STANDARD_DEVIATION 8.58 • n=7 Participants	46.53 years STANDARD_DEVIATION 8.04 • n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	52 Participants n=7 Participants	109 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	70 Participants n=7 Participants	130 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) White	102 Participants n=5 Participants	112 Participants n=7 Participants	214 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	114 Participants n=5 Participants	120 Participants n=7 Participants	234 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks after enrollment

Outcome measures

Outcome measures
Measure	Standard Consent Condition n=106 Participants 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.	CD-ROM Condition n=102 Participants 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.
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	4.17 units on a scale Standard Deviation 2.94

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome data not reported

Adverse Events

Standard Consent Condition

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CD-ROM Condition

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kristen Sorice

Fox Chase Cancer Center

Phone: 215-214-1433

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place