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pdfConcise ICD Study
Formative Evaluation Survey for Concise Informed Consent Document
OMB No. 0925004620,
Expiry Date 02/28/2013
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You received a document titled “Informed consent form” that explains a clinical trial to patients who have colorectal cancer. (A clinical trial is
called a “study” in this questionnaire.) This consent form covered a lot of information. The rest of this survey will focus on the consent form and the
information in it.
The first set of questions asks you about the consent form you read that describes the colorectal research study (trial).
1. How many treatment groups are being compared in this study?
j Two
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l
m
n
j Three
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n
j Four
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n
j Five
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n
j More than Five
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n
2. How many cancerfighting drugs will patients in Group 1 receive?
j One
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l
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n
j Two
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m
n
j Three
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n
j Four
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n
3. If you were in Group 2, how long might you stay on the drugs if your cancer improves?
j 6 weeks
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n
j 6 months
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n
j 1 year
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n
j Unclear
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n
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Concise ICD Study
4. If you were to agree to be part of this study, how is it decided what group you will be in?
j You (the participant) decides
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n
j Your doctor decides
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n
j Chance (random)
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n
j Don’t know
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n
5. Which of the following drugs are being tested in this study?
Yes
No
Unsure
Taxol
j
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n
j
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j
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n
Adriamycin
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j
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j
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n
Cisplatin
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j
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j
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n
Carboplatin
j
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j
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j
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n
Methotrexate
j
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n
j
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n
j
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n
Continue Survey
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Concise ICD Study
6. For this next set of questions, please answer each by saying whether you “agree” or
“disagree.”
Agree
Disagree
Unsure
The side effects from the drugs will affect all patients in the same way.
j
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n
j
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n
j
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n
If I signed the consent form, I would be agreeing to participate in a
j
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j
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j
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j
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n
It is unlikely that the drugs that are part of this study will cure your cancer.
j
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n
j
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j
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n
It’s up to you to decide if you will be part of this treatment study.
j
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j
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n
The consent form makes it clear what persons I should contact if I have
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What is learned from this study will help future cancer patients.
j
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j
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j
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You could choose not to have any treatment for your cancer at all.
j
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j
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j
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If you agree to be part of this study you must stay on the treatment until
j
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j
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j
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n
Published information about this study may include your name.
j
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The study drugs might not be any better than other cancer drugs.
j
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n
j
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j
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n
The drugs that are part of this study may cause your hair to fall out.
j
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n
j
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j
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n
You will be paid for taking part in this study.
j
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j
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j
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n
According to the consent form, there are other treatment options for
j
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j
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The drugs in this study will have no effect on your level of energy.
j
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j
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Your doctor can take you off the study without asking you.
j
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j
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j
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By signing the consent statement for this study, you agree that tissues
j
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research study.
One reason you would be taken off this study is if the doctor feels it is
harmful to your health.
The only reason you will be taken off this study is if the drugs make you so
sick that it is unbearable.
According to the consent form, the purpose of this study is to see what
amount (or dose) of cancer fighting drugs is better for treating colorectal
cancer
any concerns about the clinical trial
You may be responsible for some of the treatment costs not covered by
your insurance for this study.
the study is over.
colorectal cancer other than the drugs in this study.
According to the consent form, the reason this study is being conducted is
to find the treatment that will cure your cancer.
The consent form stated that this study is being done to find the treatment
that will most benefit you
According to the consent form, the purpose of this study is to see which of
the treatments is better at slowing the growth of colorectal cancer.
taken from you can be used for other studies of cancer genes.
Only staff from the hospital or clinic can look in your medical records for
information about your treatment.
Continue Survey
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7. For the next questions, please show how much you agree or disagree with the following
statements about the consent form for this study.
Please read each statement and rate how much you agree with each statement, using a
scale of Strongly Disagree to Strongly Agree.
Strongly
Strongly
Disagree
Agree
N/A
I read the consent form very carefully.
j
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The consent form was easy to understand
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The information in the consent form was clearly presented
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The consent form gave me enough information about this
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study
After reading the consent form, I feel I can make an
informed choice about participating in this study
8. These questions are about taking part in cancer clinical trials.
NOT AT
VERY likely Don't Know
ALL likely
As a result of reading this consent form, how likely is it that you would
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consider participating in a clinical trial if you were diagnosed with cancer
again and it was offered to you?
As a result of reading this consent form, how likely is it that you
recommend clinical trials to others who have been diagnosed with
cancer?
9. The following statements describe attitudes about participating in cancer clinical trials.
Please read each statement and circle how much you agree with each statement, using a
scale of Strongly Disagree to Strongly Agree.
Strongly
Strongly
Disagree
Agree
Don't Know
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Being in a clinical trial is a way for me to help others.
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I would receive better care if I participated in a clinical trial.
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My health would be followed more closely if I were in a
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Other people will benefit from the clinical trial results if I
participate in a clinical trial.
clinical trial.
Being in a clinical trial would give me the best and newest
treatments.
Being in a clinical trial could give me a better chance of
being cured.
Patient Education Materials
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Concise ICD Study
10. For the last part of this questionnaire, please show how much you agree or disagree
with the following statements about the patient education materials you received.
Strongly
Strongly
Disagree
Agree
Don't Know
I read the materials very carefully.
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The materials were easy to understand.
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The materials provided information that was useful to me in
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The information in the materials was clearly presented.
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I liked the way the materials looked.
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The materials served as a useful reference when I needed to
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deciding to join the study or not.
The materials helped me decide whether or not to
participate in this study.
remember specific information about this study
Demographics
The following questions are asked for statistical purposes and are only used in aggregate. Results for these questions
remain secure, as do all other answers in this survey.
*11. Are you…?
j Female
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n
j Male
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n
12. What is your approximate annual household income?
j Under $25,000
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n
j $25,000$49,999
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j $50,000$74,999
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j $75,000$99,999
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j $100,000$149,999
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j $150,000 or over
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n
13. What was the last grade you completed in school?
j Some high school
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n
j High school graduate
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j Some college
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n
j College graduate
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j Postgraduate/professional
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n
Page 5
Concise ICD Study
*14. Which of the following best describes your ethnicity?
j Hispanic/Latino
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n
j Not Hispanic or Latino
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n
*15. Which one or more best describes your race?
c American Indian or Alaska Native
d
e
f
g
c Asian
d
e
f
g
c Black or African American
d
e
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g
c Native Hawaiian or other Pacific Islander
d
e
f
g
c White
d
e
f
g
*16. What is your zip code of the area your home is located in?
Thank You for Your Help
This completes the survey. Thank you very much for your time and opinions.
SPECIFIC INSTRUCTIONS FROM THE PANEL PROVIDER WILL BE ADDED WITH REGARDS TO INCENTIVES, ETC.
Page 6
| File Type | application/pdf |
| File Modified | 2012-03-26 |
| File Created | 2012-03-26 |