Accelerated Approval Disclosures Study II Appendices A B C D

APPENDIX A
Consent Form (Pretest and Main Study)
Any text in angled brackets “< >” indicates part of the script that will change based on
the participant or situation. The intended content (or content options) is indicated in the
brackets.
What is the Research About?
Thank you for your interest in this research study. The research involves looking at a
website for a cancer treatment and completing an online questionnaire. Viewing the website
and completing the survey will take approximately 20 minutes.
What Is the Purpose of This Study?
The purpose of the study is to learn more about websites for cancer treatments. You are
one of about people in the United
States who are being asked to take part in this survey.
Who Is Leading the Study?
RTI International, an independent nonprofit research organization, is conducting this study
on behalf of the Department of Health and Human Services. RTI is working with Kantar to
conduct this survey but is not affiliated with Kantar in any way.
Do I Have to Take Part in This Study?
Your participation in this study is completely voluntary, and you have the right to stop at
any time or to refuse to answer any question. If you decide to participate and later change
your mind, you will not be contacted again or asked for further information.
What Are the Possible Risks?
We do not expect that any of the survey questions will make you uncomfortable, but if they
do, you can refuse to answer any question. There is also a potential risk of loss of
confidentiality. Every effort will be made to protect your information, but this cannot be
guaranteed.
Will I Benefit From Taking Part in This Study?
There are no direct benefits to you for participating in this study. However, you will be
helping with an important research project.
Will I Receive Any Payment for Taking Part in This Study?
You will receive points equivalent to approximately $10 for completing this survey.
Who Will See the Information I Give?

Many precautions have been taken to protect your information. All information collected in
this survey will be kept confidential to the extent provided by law. You will never be
identified by name. The information obtained from all of the surveys will be combined into a
summary report so that details of individual questionnaires cannot be linked to a specific
participant. When we analyze the results, your responses will be combined with responses
from other people taking part in the study. You will not be identified in any published or
presented materials. The information collected in this study may be used or shared for
future research studies.
Will I Be Contacted in the Future About This Study?
You will not be contacted in the future about this research after your participation ends.
What If I Have Questions?
If you have questions about this survey, please contact your panel provider through your
member website for assistance. You will need to mention the Project # [SurveyNumber],
and someone will direct your questions to the appropriate researchers at RTI. If you have
questions about your rights as a participant, you can call RTI’s Office of Research Protection
toll-free at 1-866-214-2043.
[Consent Screen 3]
If you have read the previous screens and agree to participate, please click the
Yes button. If not, click the No button.

Yes, I agree to participate. [CONTINUE AND RANDOMLY ASSIGN
PARTICIPANT TO EXPERIMENTAL CONDITION]

No, I do not agree to participate. [TERMINATE SURVEY]

Appendix B:
Pretest and Main Study Screener
An agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB control number.
OMB control#: XXX; Expiration: xxx
Thank you for your interest in this research study. The research involves looking at a
website for a cancer treatment and completing an online questionnaire. First, we need to
ask you a few screening questions to see if you are eligible to participate. Then, if you are
eligible and agree to participate, you will be asked to view a website. After viewing the
website, we will ask you to complete a survey. Viewing the website and completing the
survey will take approximately 20 minutes.
[PROGRAMMER: NEXT SCREEN]
S1. What is your age? ______ [IF <18, TERMINATE]
[PROGRAMMER: NEXT SCREEN]
[SINGLE PUNCH]
S2. What is your occupation?
1. Healthcare provider (e.g., physician, nurse, physical therapist) [TERMINATE]
2. Pharmaceutical employee (e.g., pharma rep) [TERMINATE]
3. Market research employee or advertising employee [TERMINATE]
4. Employee of the Department of Health and Human Services [TERMINATE]
5. None of the above [CONTINUE]
[PROGRAMMER: NEXT SCREEN]
[SINGLE PUNCH]
S3. Have you ever been diagnosed with cancer by a doctor or other qualified
health care provider?
1. Yes [CONTINUE TO S4s]
2. No [CONTINUE TO S4c]
[PROGRAMMER: NEXT SCREEN]
[SINGLE PUNCH]
S4s. When was the first time that a doctor or other health care professional told
you that you had cancer?
1. Less than six months ago
2. Between six months and less than two years ago
3. Between two years and less than five years ago

4. Between five years and less than ten years ago
5. More than ten years ago
[PROGRAMMER: NEXT SCREEN]
[SELECT ALL THAT APPLY]
S5s. What type of cancer(s) were you diagnosed with?

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

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Acute lymphocytic (or lymphoblastic) leukemia (ALL)
Basal cell carcinoma [CONTINUE TO S4c]
Bladder cancer
Bone cancer
Breast cancer
Brain cancer
Cervical cancer
Chronic lymphocytic leukemia (CLL)
Chronic myeloid leukemia (CML)
Colon & rectal
Endometrial cancer
Kaposi's sarcoma
Kidney cancer
Leukemia, includes Acute myeloid leukemia (AML)
Lip & oral cancer
Liver cancer
Lung cancer
Lymphoma, includes non-Hodgkin lymphoma, Hodgkin lymphoma Multiple
myeloma
Melanoma
Merkel cell carcinoma [CONTINUE TO S4c]
Mesothelioma
Non-small cell lung cancer
Nonmelanoma skin cancer [CONTINUE TO S4c]
Oral cancer
Ovarian cancer
Pancreatic cancer
Prostate cancer
Sarcoma
Skin cancer [CONTINUE TO S4c]
Small cell lung cancer
Squamous cell carcinoma [CONTINUE TO S4c]
Thyroid Cancer
Other

[Note: the distribution of S5s to be examined in the pretest to determine the feasibility of
including quotas in main study]

[PROGRAMMER: NEXT SCREEN]
[SINGLE PUNCH]
S6s. Are you currently in active treatment for your cancer? Active treatment could
include surgery, radiation, or receiving medication like chemotherapy,
immunotherapy, or hormone therapy.
1. Yes [TERMINATE]
2. No [CONTINUE]
[PROGRAMMER: NEXT SCREEN]
[SELECT ALL THAT APPLY]
S7s. What type(s) of cancer treatment have you received for your cancer?
Select all that apply

 I received medications such as pills or infusions to treat cancer (for

example: chemotherapy, immunotherapy, hormone therapy, targeted
therapy)
 I received other cancer treatment (for example: surgery, radiation, stem
cell or bone marrow transplant)
 I have not received any medical treatment for cancer [CONTINUE TO S4c]
[Note: the distribution of S7s to be examined in the pretest to determine the feasibility of
restricting recruitment in the main study to those who received a systemic treatment]
[PROGRAMMER: NEXT SCREEN]
[SINGLE PUNCH]
S4c. Have you ever provided care for or made health care decisions for someone
with cancer?
1. Yes [CONTINUE]
2. No [TERMINATE]
[PROGRAMMER: NEXT SCREEN]
[SINGLE PUNCH]
S5c. Was any of this care provided as part of a job (for example, as a nurse or
professional home health aide)?
1. Yes [TERMINATE]
2. No [CONTINUE]
[PROGRAMMER: NEXT SCREEN]
[SELECT ALL THAT APPLY]
S6c. Thinking about the person you provided care for, what type of cancer(s) did
they have?


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


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
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


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









Acute lymphocytic (or lymphoblastic) leukemia (ALL)
Basal cell carcinoma [TERMINATE]
Bladder cancer
Bone cancer
Breast cancer
Brain cancer
Cervical cancer
Chronic lymphocytic leukemia (CLL)
Chronic myeloid leukemia (CML)
Colon & rectal
Endometrial cancer
Kaposi's sarcoma
Kidney cancer
Leukemia, includes Acute myeloid leukemia (AML)
Lip & oral cancer
Liver cancer
Lung cancer
Lymphoma, includes non-Hodgkin lymphoma, Hodgkin lymphoma Multiple
myeloma
Melanoma
Merkel cell carcinoma [TERMINATE]
Mesothelioma
Non-small cell lung cancer
Nonmelanoma skin cancer [TERMINATE]
Oral cancer
Ovarian cancer
Pancreatic cancer
Prostate cancer
Sarcoma
Skin cancer [TERMINATE]
Small cell lung cancer
Squamous cell carcinoma [TERMINATE]
Thyroid Cancer
Other

[Note: the distribution of S6c to be examined in the pretest to determine the feasibility of
including quotas in main study]
[PROGRAMMER: NEXT SCREEN]
[SELECT ALL THAT APPLY]
S7c. Thinking about the person you provided care for, what type(s) of cancer
treatment have they received for their cancer?
Select all that apply

 They received medications such as pills or infusions to treat cancer (for

example: chemotherapy, immunotherapy, hormone therapy, targeted
therapy)
 They received other cancer treatment (for example: surgery, radiation,
stem cell or bone marrow transplant)
 They have not received any medical treatment for cancer [TERMINATE]
 I don’t know what type of cancer treatment they received
[Note: the distribution of S7c to be examined in the pretest to determine the feasibility of
restricting recruitment in the main study to those who received a systemic treatment]
[PROGRAMMER: NEXT SCREEN]
[SINGLE PUNCH]
S8. What is your sex?
1. Male
2. Female
3. Prefer not to answer
[PROGRAMMER: NEXT SCREEN]
[SINGLE PUNCH]
S9. Are you Hispanic or Latino?
1. Yes
2. No
3. Prefer not to answer
[PROGRAMMER: NEXT SCREEN]
[SELECT ALL THAT APPLY]
S10. What is your race? (You may select one or more races.)
1. American Indian or Alaska Native
2. Asian
3. Black or African American
4. Native Hawaiian or other Pacific Islander
5. White
6. Prefer not to answer
[PROGRAMMER: NEXT SCREEN]
[SINGLE PUNCH]

S11. What is the highest level of school you have completed or the highest degree
you have received?
1. Less than high school

2. High school graduate—high school diploma or the equivalent (for example: GED)
3. Some college but no degree
4. Vocational or Technical School degree
5. Associate’s degree
6. Bachelor’s degree (for example: BA, AB, BS)
7. Some postgraduate work but no degree
8. Advanced or post-graduate degree (for example: Master’s degree, MD, DDS, JD,
PhD, EdD)
[DISPLAY IF EFLAG=0 ‘INELIGIBLE’]
[Thank and Terminate—Ineligible]
[PROGRAMMER: NEXT SCREEN]
We’re sorry, but you are not eligible for this study. There are many possible reasons why
people are not eligible for this study. These reasons were decided earlier by the researchers.
However, thank you for your interest in this study and for taking the time to answer our
questions today.
[TERMINATE IF EFLAG=0 ‘INELIGIBLE’]
[IF EFLAG=1 ‘ELIGIBLE’; CONTINUE, RANDOMLY ASSIGN PARTICIPANTS TO A STUDY
CONDITION]
[PROGRAMMER: NEXT SCREEN]
You are eligible to participate in the study. We will show you a website for a cancer
treatment. Make sure you are comfortable and can read the screen from where you sit. The
study will take about 20 minutes to complete. We ask you to complete the study in one
sitting (without taking any breaks) in order to avoid distractions.

APPENDIX C:

Accelerated Approval Study II Questionnaire 

[Screener and consent to be inserted] 
INTRODUCTION 
Thank you for agreeing to participate in this study today. We are going to show you a website with 
information about a prescription drug that treats a kind of cancer and then ask you some questions 
about it. 
//NEW SCREEN// 
We’d like to start by telling you a bit about a kind of cancer. It’s called acute lymphoblastic leukemia.  
The word “acute” means that this type of leukemia can progress very quickly and, if not treated, can 
cause death within a few months.  
Cancers start when cells in the body begin to grow out of control.  Acute lymphoblastic leukemia is a 
cancer of a certain type of white blood cell called lymphocytes.  This cancer starts in the bone marrow – 
the soft, spongy tissue inside bones that makes lymphocytes. It can also spread to other parts of the 
body. 
With this cancer, the body makes too many immature lymphocytes which are not able to mature and 
work normally.  These leukemia cells crowd out the normal cells in the bone marrow. This means there 
is less room for mature white blood cells (which fight infection), red blood cells (which carry oxygen), 
and platelets (which help blood to clot).  
There are few treatment options available for people with acute lymphoblastic lymphoma. 
//NEW SCREEN// 


Next we will show you the website.



When you read it, imagine that someone close to you was recently diagnosed with acute
lymphoblastic leukemia and you would like to learn more about their treatment options.



Take as much time as you need to look at the website.



After you leave the website you won’t be able to return to it while answering the questions.

[Study 1: Display appropriate stimuli based on randomized experimental condition: no accelerated 
approval disclosure, low prominence/ physician labeling disclosure, high prominence/physician labeling 
disclosure, low prominence/consumer‐friendly disclosure, high prominence/consumer‐friendly 
disclosure] 
Study 1 Design 
Accelerated Approval Language 

Placement 

1

Physician labeling version 
Consumer‐friendly version 
None 

Condition 1: High prominence 
Condition 2: Low prominence 
Condition 3: High prominence 
Condition 4: Low prominence 
Condition 5: N/A 

[Physician labeling version: This indication is based on response rate. An improvement in 
survival or disease‐related symptoms has not been established. Continued approval for this 
indication may be contingent upon verification of clinical benefit in subsequent trials.] 
[Consumer‐friendly version: In a clinical trial, [Drug X] returned blood counts to normal. 
However, we currently do not know if [Drug X] helps people live longer or feel better. We 
continue to study [Drug X] in clinical trials to learn more about [Drug X]’s benefits.] 
[Study 2: Display appropriate stimuli based on randomized experimental condition: approval basis, 
approval basis + unknown outcomes, approval basis + confirmatory trials, approval basis + unknown 
outcomes + confirmatory trials = consumer‐friendly high prominence condition from Study 1] 
Study 2 Design 
Confirmatory trials 
Absent 

Unknown 
outcomes 

Absent 

Condition 1: In a clinical trial, 
[Drug X] returned blood counts 
to normal.  

Present 

Condition 3: In a clinical trial, 
[Drug X] returned blood counts 
to normal. However, we 
currently do not know if [Drug 
X] helps people live longer or
feel better.

Present 
Condition 2: In a clinical trial, [Drug X] 
returned blood counts to normal. We 
continue to study [Drug X] in clinical trials 
to learn more about [Drug X]’s benefits. 
Condition 4: In a clinical trial, [Drug X] 
returned blood counts to normal. 
However, we currently do not know if 
[Drug X] helps people live longer or feel 
better. We continue to study [Drug X] in 
clinical trials to learn more about [Drug 
X]’s benefits. 

//NEW SCREEN// 
Question Type:  Single Punch  
Q1. Were you able to view the website?  
Value 
01 
00 
02 
‐99 

Value Label 
Yes  
No 
Not Sure 
Refused 

2

[If Q1=00 OR Q1=02 OR Q1=‐99, Terminate] 
//NEW SCREEN// 
Question Type:  Single Punch  
[Randomize order of 01‐03. 04 always appears last.] 
Q2. [Drug X] is a treatment option for 
Value 
01 
02 
03 
04 
‐99 

Value Label 
Human Immunodeficiency Virus 
Myocardial infarction 
Acute lymphoblastic leukemia 
Not sure / Don’t know 
Refused 

//NEW SCREEN// 
Question type: Text box 
Q3. What can [Drug X] do for people with acute lymphoblastic leukemia? 

 [Open Field]  
[Codes: blood cell counts return to normal, gets rid of any detectable evidence of leukemia/no signs of 
leukemia/remission, cure, live longer, feel better/reduce symptoms, other codes to be determined 
based on cognitive interviews and pretesting] 
//NEW SCREEN// 
Question Type:  Single Punch  
Q4. Did the website say that there are things we do not know yet about what [Drug X] can do for people 
with acute lymphoblastic leukemia? 
Value 
01 
00 
02 
‐99 

Value Label 
Yes  
No 
Not Sure 
Refused 

//NEW SCREEN// 
[If Q4=01, ask Q5] 

3

Question type: Text box 
Q5. What don’t we know yet about what [Drug X] can do for people with acute lymphoblastic leukemia? 
(Please be as detailed and specific as possible when entering your answer in the space provided.) 

[Codes: blood cell counts return to normal, gets rid of any detectable evidence of leukemia/no signs of 
leukemia/remission, cure, live longer, feel better/reduce symptoms, other codes to be determined 
based on cognitive interviews and pretesting] 
//NEW SCREEN// 
Question Type:  Grid  
[Randomize order of Q6 A – D] 
Q6. Based on the information on the website, mark whether each of the statements below is true, false, 
or you don’t know: 
Variable 
Q6_A 
Q6_B 

Variable Text 
[Drug X] has been shown to cure acute lymphoblastic leukemia. 
[Drug X] has been shown to help people with acute lymphoblastic leukemia 
live longer. 
[Drug X] has been shown to help people with acute lymphoblastic leukemia 
feel better. 
[Drug X] helps blood cell counts return to normal. 

Q6_C 
Q6_D 
Value 
01 
02 
03 
‐99 

Value Label 
True 
False 
Don’t Know 
Refused 

//NEW SCREEN// 
Question Type:  Grid  
[Randomize order of 00‐02: first to last or last to first] 
Q7. Please select one response. On average, people with acute lymphoblastic leukemia who take [Drug 
X]…  
Value 
00 

Value Label 
Don’t live as long as people who don’t take [Drug X]. 

01 

Live the same amount of time as people who don’t take [Drug X]. 

4

02 

Live longer than people who don’t take [Drug X]. 

03 

No one knows yet whether people who take [Drug X] live longer or not. 

‐99 

Refused 

//NEW SCREEN// 
[If Q7=02, ask Q8] 
Question type: Numeric string plus drop‐down option 
Q8. You mentioned that [Drug X] would help people with acute lymphoblastic leukemia live longer. On 
average, how much longer do you think people with acute lymphoblastic leukemia who take [Drug X] 
would live? Your best guess is fine.  
(Please write a number in the space below and choose from the dropdown list whether it is weeks, 
months, or years. You will need to enter a single number, so if you have a range in mind, please pick the 
middle number in the range.)  
(Q8_A: Open ended numeric string) 
Q8_B: Unit selection answer choices 

Value 
1 
2 

Value Label 
weeks longer 
months longer 

3 

years longer 

‐99 
‐100 

Refused 
Valid skip 

//NEW SCREEN// 
Question Type:  Single Punch  
Q9. The website suggests that [Drug X] will improve the quality of life for people who take it… 
[Randomize order of response options] 
Value 
01 
02 
‐99 

Value Label 
Disagree 
Agree 
Refused 

//NEW SCREEN// 

5

[Randomize order of Q10 – Q11] 
[ASK Q10 IF PRETEST OR MAIN STUDY] 
Please indicate your level of agreement with the following statements. 
Question Type:  Single Punch  
Q10. The benefits of [Drug X] outweigh any side effects it may have. 
Value 
01 
02 
03 
04 
99 
‐99 

Value Label 
1 Strongly disagree 
2 Disagree 
3 Agree 
4 Strongly agree 
Don’t know 
Refused 

Question Type:  Single Punch  
Q11. [Drug X] might have serious side effects. 
Value 
01 
02 
03 
04 
99 
‐99 

Value Label 
1 Strongly disagree 
2 Disagree 
3 Agree 
4 Strongly agree 
Don’t know 
Refused 

//NEW SCREEN// 
[DO NOT SHOW Q12 OR Q12alt IN STUDY 1; RANDOMIZE TO Q12 OR Q12alt IN STUDY 2 PRETEST] 
Question Type:  Single Punch  
[Randomize order of Q12 A – B] 
Q12. Based on the information on the website, mark whether each of the statements below is true, 
false, or you don’t know: … 
Variable 
Q12_A 
Q12_B 

Variable Text 
Currently, more data is needed to know whether [Drug X] helps people with 
acute lymphoblastic leukemia live longer. 
Currently, more date is needed to know whether [Drug X] helps people with 
acute lymphoblastic leukemia feel better. 

6

Value 
00 
01 
02 
‐99 

Value Label 
True 
False 
Don’t know 
Refused 

//NEW SCREEN// 
Question Type:  Multi‐Punch  
Q12alt. Researchers continue to study [Drug X] in clinical trials. What do you think are the main reasons 
additional clinical trials are needed? (check all that apply): 
Variable 
Q12alt_A 
Q12alt_B 

Q12alt_F 

Variable Text 
Because more data can help us learn even more about [Drug X]’s benefits. 
Because we don’t have enough data to know whether [Drug X] helps people 
with acute lymphoblastic leukemia live longer. 
Because we don’t have enough data to know whether [Drug X] helps people 
with acute lymphoblastic leukemia feel better. 
Because more data can help us learn even more about [Drug X]’s side 
effects. 
Because we don’t have enough data to know whether [Drug X] improves 
quality of life for people with acute lymphoblastic leukemia. 
Other reason, specify 

Q12alt_G 

None of the above. 

Q12alt_DK 

Don’t know 

Q12alt_C 
Q12alt_D 
Q12alt_E 

Value 
00 
01 
‐99 

Value Label 
Not checked 
Checked 
Refused 

//NEW SCREEN// 
Question Type:  MultiPunch  
Q13. If a loved one was diagnosed with acute lymphoblastic leukemia, I would suggest that they ask 
their doctor about… 
[Randomize order] 
Q13_A  Taking [Drug X] 
Q13_B  [Drug X]’s risks 
Q13_C  [Drug X]’s benefits 

7

Q13_D  [Drug X]’s FDA approval 
Value 
00 
01 
‐99 

Value Label 
No 
Yes 
Refused 

//NEW SCREEN// 
Question Type:  Grid  
[Randomize order of Q14 A – C] 
Q14. Please check how much you agree or disagree with the following statements about the website 
you saw.  
Q14_A  This website is a reliable source of information about the risks and benefits of [Drug X]. 
Q14_B  I feel I’ve been accurately informed after viewing this website. 
Q14_C  This website provides consumers with essential information for deciding whether to ask a 
doctor about [Drug X]. 
Value 
01 
02 
03 
04 
05 
‐99 

Value Label 
Strongly disagree 
Disagree 
Neither 
Agree 
Strongly Agree 
Refused 

//NEW SCREEN// 
Question Type:  Single Punch  
Q15a. The following statement may or may not have been on the website you saw.  
Did you see this statement on the website?  
Study 1 – condition 1, 2 display: An improvement in survival or disease‐related symptoms has not been 
established. Continued approval for this indication may be contingent upon verification of clinical 
benefit in subsequent trials. 
Study 1 – condition 3, 4 display: In a clinical trial, [Drug X] returned blood counts to normal. However, 
we currently do not know if [Drug X] helps people live longer or feel better. We continue to study [Drug 
X] in clinical trials to learn more about [Drug X]’s benefits.
Study 1 – condition 5 ‐ control condition: randomize displaying either physician labeling or consumer‐
friendly disclosure condition. 

8

[Study 2: Unknown outcomes statement] 
Study 2 – condition 1, 2, 3, 4 display: However, we currently do not know if [Drug X] helps people live 
longer or feel better.  
Statement: [Display the disclosure that matches the programming notes above] 
Value 
01 
00 
‐99 

Value Label 
Yes, I saw it on the website  
No, I did not see it on the website 
Refused 

//NEW SCREEN// 
[Keep the text below on screen for Q16a and Q17a:  
Please read the statement below. 
Study 1 – condition 1, 2 display: An improvement in survival or disease‐related symptoms has not been 
established. Continued approval for this indication may be contingent upon verification of clinical 
benefit in subsequent trials. 
Study 1 – condition 3, 4 display: In a clinical trial, [Drug X] returned blood counts to normal. However, 
we currently do not know if [Drug X] helps people live longer or feel better. We continue to study [Drug 
X] in clinical trials to learn more about [Drug X]’s benefits.
Study 1 – condition 5 ‐ control condition: randomize displaying either physician labeling or consumer‐
friendly disclosure condition. 
[Study 2: Display unknown outcomes statement] 
Study 2 – condition 1, 2, 3, 4: However, we currently do not know if [Drug X] helps people live longer or 
feel better.  
Statement: [Display the disclosure that matches the programming notes above] 
Question Type:  Grid  
Q16a. In my opinion, the statement is… 
[RANDOMIZE ORDER OF ITEMS Q16a_1 to Q16a_4] 
1 

2 

3 

4 

5 

6 

Q16a_1  Confusing 

 

 

 

 

 

 

Clear 

Q16a_2  Complex 

 

 

 

 

 

 

Straightforward 

Q16a_3  Unimportant 

 

 

 

 

 

 

Important 

Q16a_4  Misleading 

 

 

 

 

 

 

Honest 

9

//NEW SCREEN// 
Question type: Text Box 
Q17a. What does the statement mean to you?  

[Open Field]   
[Codes to be determined based on cognitive interviews and pretesting] 
//NEW SCREEN// 
[Show Q15b only in Study 2] 
Question Type:  Single Punch  
Q15b. The following statement may or may not have been on the website you saw.  
Did you see this statement on the website?  
Study 2 condition 1, 2, 3, 4: We continue to study [Drug X] in clinical trials to learn more about [Drug X]’s 
benefits.  
Statement: [Display the disclosure that matches the programming notes above] 
Value 
01 
00 
‐99 

Value Label 
Yes, I saw it on the website  
No, I did not see it on the website 
Refused 

//NEW SCREEN// 
[Keep the text below on screen for Q16b and Q17b:  
Please read the statement below. 
[Study 2: Display confirmatory trials statement] 
Study 2 condition 1, 2, 3, 4 display: We continue to study [Drug X] in clinical trials to learn more about 
[Drug X]’s benefits.  
Statement: [Display the disclosure that matches the programming notes above] 
[Show Q16b only in Study 2] 
Question Type:  Grid  

10

Q16b. In my opinion, the statement is… 
[RANDOMIZE ORDER OF ITEMS Q16b_1 to Q16b_4] 
1 

2 

3 

4 

5 

6 

Q16b_1  Confusing 

 

 

 

 

 

 

Clear 

Q16b_2  Complex 

 

 

 

 

 

 

Straightforward 

Q16b_3  Unimportant 

 

 

 

 

 

 

Important 

Q16b_4  Misleading 

 

 

 

 

 

 

Honest 

//NEW SCREEN// 
[Show Q17b only in Study 2] 
Question type: Text Box 
Q17b. What does the statement mean to you?  

[Open Field]   
[Codes to be determined based on cognitive interviews and pretesting] 
//NEW SCREEN// 
[ASK Q18 IF PRETEST OR MAIN STUDY] 
Question Type: Single Punch  
Q18. How often do you need to have someone help you when you read instructions, pamphlets, or 
other written material from your doctor or pharmacy? 
Value 
01 
02 
03 
04 
05 
‐99 

Value Label 
Never 
Rarely 
Sometimes 
Often 
Always 
Refused 

//NEW SCREEN// 
[ASK Q19 IF PRETEST OR MAIN STUDY] 

11

Question Type:  Single Punch  
Q19. How familiar were you with treatments for acute lymphoblastic leukemia before today? 
Value 
01 
02 
03 
04 
05 
‐99 

Value Label 
Not at all 
A little bit 
Somewhat 
Quite a bit 
Extremely 
Refused 

//NEW SCREEN// 
Q20. On average, how likely would a person diagnosed with acute lymphoblastic leukemia be to live 
more than 5 years?  
Value 
01 
02 
03 
04 
‐99 

Value Label 
Not at likely 
Somewhat likely 
Moderately likely 
Very likely 
Refused 

[CANCER SURVIVORS ONLY] 
Question Type:  Multi‐Punch  
Q21s. What type(s) of cancer treatment did you receive for your cancer? (check all that apply) 
Q21s_A 
Q21s_B 
Q21s_C 
Q21s_D 
Q21s_E 
Q21s_F 

Value 
00 
01 
‐99 

Surgery  
Radiation  
Chemotherapy (pills or infusions) 

Immunotherapy, hormone therapy, or targeted therapy  

Stem cell or bone marrow transplant 
Other cancer treatments 

Value Label 
Not checked 
Checked 
Refused 

[CANCER CAREGIVERS ONLY] 
Question Type:  Multi‐Punch  

12

Q21c. Thinking about the person you provided cancer‐related care for, what type(s) of cancer treatment 
have they received for their cancer? (check all that apply) 
Q21c_A 
Q21c_B 
Q21c_C 
Q21c_D 
Q21c_E 
Q21c_F 
Q21c_G 

Value 
00 
01 
‐99 

Surgery  
Radiation  
Chemotherapy (pills or infusions) 

Immunotherapy, hormone therapy, or targeted therapy  

Stem cell or bone marrow transplant 
Other cancer treatments 
Don’t know 

Value Label 
Not checked 
Checked 
Refused 

//NEW SCREEN// 
Question Type: Single Punch 
Q22. Have you ever heard of the term “accelerated approval” as it relates to prescription drugs and the 
Food and Drug Administration? 
Value 
01 
02 
03 
‐99 

Value Label 
Yes 
No  
Don’t know  
Refused 

//NEW SCREEN// 
Question Type: Single Punch  
[If Q22=01, ask Q23] 
Q23. How familiar are you with the topic of accelerated approval of prescription drugs? 
Value 
01 
02 
03 
‐99 

Value Label 
A little familiar 
Somewhat familiar 
Very familiar  
Refused 

//NEW SCREEN// 

13

[CANCER CAREGIVERS ONLY] 

Question Type: Single Punch  

Q24c. Think about the individual for whom you are currently providing or have provided cancer‐related 
care. What is your relationship to that person? They are my:  

Value  Value Label 
01 
Spouse/partner 
02 
Child 
03 
Parent 
04 
Sibling 
05 
Friend 
06 
Other, specify 

//NEW SCREEN// 

[CANCER CAREGIVERS ONLY] 

Question Type: Single Punch  

Q25c. Think about the individual for whom you are currently providing or have provided cancer‐related 
care. About how long have you provided care for this person? 

Value  Value Label 
01 
Less than 30 days 
02 
1 to 6 months 
03 
7 months to 2 years 
04 
3 to 5 years 
05 
More than 5 years 

//NEW SCREEN// 

[ASK Q26 IF PRETEST OR MAIN STUDY] 

Question Type: Single Punch  
Q26. How much do you trust information provided by pharmaceutical companies about prescription 
drugs?  
Value 
01 
02 
03 
04 

Value Label 
Not at all 
A little 
Some 
A lot 

//NEW SCREEN// 

14

[PRETEST ONLY] 
Question Type: Single Punch  
Q27. How similar was the website for [DRUG X] to websites that you have seen for other prescription 
drugs? 
Value 
01 
02 
03 
04 
98 
‐99 

Value Label 
Not at all similar 
Somewhat similar 
Very similar 
Extremely similar 
Don’t know 
Refused 

//NEW SCREEN// 
The purpose of this study is to learn about reactions to prescription drug information. To get a real‐life 
reaction, we used a pretend product in this study. While [Drug X] is not a real product and is not 
available for sale, your participation in this important study helps FDA better understand how to 
communicate the benefits and risks of prescription drugs to consumers clearly and usefully. Your 
responses will help make prescription drug information clearer.  Please see your health care professional 
for questions about acute lymphoblastic leukemia. 
You have been very helpful. Thank you very much for your participation! 
[PRETEST ONLY] 
Question Type: Text box  
Q30. Please share any additional thoughts you had about the website or this survey. 

[Open Field]   

15

APPENDIX D:
Pretest and Main Study Recruitment Email

Hello [FIRSTNAME],

You’re so close to your next reward, [FIRSTNAME]

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fast track you to your next reward, [FIRSTNAME].
Take this survey now for the chance to collect more LPs and get
closer to your next reward.

Hurry! Use the button below to
take your next survey now.

GO NOW!

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Kantar owned company). Our members complete surveys to
earn virtual points (LPs) that can be redeemed for e-gift cards
and PayPal.

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