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Pretests 1 and 2

ICR 202007-0910-004 · OMB 0910-0885 · Object 102560101.

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application/vnd.openxmlformats-officedocument.wordprocessingml.document
Pretests 1 and 2
Sullivan, Helen W (CDER)
Writer
2019-11-21
2026-09-15
complete

Extracted Text

Oncology Indication Study 2 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 television ad for a prescription drug that treats a kind of cancer and then ask you some questions about it.

The survey will take about 20 minutes to complete. We ask you to complete the survey in one sitting (without taking any breaks) to avoid distractions. Your input is extremely valuable.


[Display appropriate questionnaire and stimuli based on study: non-small cell lung cancer or multiple myeloma conditions]

//NEW SCREEN//

[Non-small cell lung cancer conditions]

We’d like to start by telling you a bit about a kind of cancer. It’s called non-small cell lung cancer. 

Lung cancer starts when cells of the lung become abnormal and begin to grow out of control. 

As more cancer cells develop, they can form into a tumor and spread to other areas of the body.

Lung cancer is the leading cause of cancer death in the United States for both men and women. 

There are 2 main types of lung cancer:

•	About 80% to 85% of lung cancers are non-small cell lung cancer.
•	About 10% to 15% are small cell lung cancer

[Multiple myeloma conditions]

We’d like to start by telling you a bit about a kind of cancer. It’s called multiple myeloma. 

Cancer starts when cells begin to grow out of control. Cells in nearly any part of the body can become cancer, and can spread to other areas.

Multiple myeloma is a cancer of plasma cells. Normal plasma cells are found in the bone marrow and are an important part of the immune system. 

In general, when plasma cells become cancerous and grow out of control, this is called multiple myeloma. It can lead to complications such as low red blood cells (anemia), more frequent infections, kidney damage, and bone pain/fractures. 

While some patients may not have symptoms of multiple myeloma, for other patients the symptoms of the disease can be severe and can lead to death.  

//NEW SCREEN//

[insert audio check question]
[Participants will be required to pass the audio check—indicating they are able to play videos and hear audio on their device/computer before proceeding]
//NEW SCREEN//

    • Next, we will show you the TV ad. 

    • While you watch it, imagine that someone close to you has [non-small cell lung cancer, multiple myeloma] and you would like to learn more about their treatment options. Do your best to remember details about the ad.  

    • Please make sure the sound on your computer, tablet or mobile phone is turned on and your volume is turned up.

    • The ad may take 15-30 seconds to start playing.

    • Once you finish viewing the ad, please click the Continue button.

[Display appropriate stimuli based on randomized experimental condition: material information in superimposed text only, material information in audio only, material information in superimposed text and audio, or material information not in superimposed text or audio]

[Suppress “Continue” button until ad finishes playing] 
We would like you to watch the ad a second time. Please click the Continue button to view the ad.
[Display assigned ad again] [Suppress “Continue” button until ad finishes playing] 


MANIPULATION CHECK

Question Type:  Single Punch 
Q1. Were you able to view the TV ad? 

Value
Value Label
01
Yes 
00
No
-99
Refused

[If Q1=00 OR Q1=-99, Terminate and show “We’re sorry, but you are not eligible for this study. Thank you for your interest in this study and for taking the time to answer our questions today.”]

UNDERSTANDING/RETENTION ITEMS

[We will use cognitive interviews to determine which retention items to include and the order in which to present them]

Question type: Text box
Q2. Who is [Drug X, Drug Y] for?


 [Open Field] 

[Non-small cell lung cancer codes: non-small cell lung cancer/NSCL, lung cancer, cancer, previously treated with platinum-based chemotherapy, previously treated in general, people who have a certain type of ALK gene, based on genetics generally, certain people generally, adults, other codes to be determined based on cognitive interviews and pretesting]

[Multiple myeloma codes: multiple myeloma, cancer, in combination with dexamethasone, with other drugs generally, people who have received at least three prior medicines, adults, received prior treatment generally, other codes to be determined based on cognitive interviews and pretesting]

Question type: Single punch
Q2B. What does [Drug X, Drug Y] treat?
Value
Value Label
01
Non-small cell lung cancer 
02
Chronic obstructive pulmonary disease 
03
Multiple myeloma
04
Fibromyalgia
99
Don’t know
-99
Refused [Skip Q4]

//NEW SCREEN//

Question type: Single punch
Q3. Can anyone with [non-small cell lung cancer, multiple myeloma] take [Drug X, Drug Y]? 

Value
Value Label
01
Yes [Skip Q4] 
00
No [Ask Q4] 
99
Don’t know [Skip Q4]
-99
Refused [Skip Q4]

//NEW SCREEN//

Question type: Text box
Q4. Who can take [Drug X, Drug Y]?



[Open Field] 

[Non-small cell lung cancer codes: non-small cell lung cancer/NSCL, lung cancer, cancer, previously treated with platinum-based chemotherapy, previously treated in general, people who have a certain type of ALK gene, based on genetics generally, certain people generally, adults, other codes to be determined based on cognitive interviews and pretesting]

[Multiple myeloma codes: multiple myeloma, cancer, in combination with dexamethasone, with other drugs generally, people who have received at least three prior medicines, received prior treatment generally, adults, other codes to be determined based on cognitive interviews and pretesting]

//NEW SCREEN//

Question type: Single punch
Q5. Is [Drug X, Drug Y] used in combination with another cancer treatment? 

Value
Value Label
01
Yes [Ask Q6]
00
No [Skip Q6]
99
Don’t know [Skip Q6]
-99
Refused [Skip Q6]

//NEW SCREEN//

Question type: Single punch
Q6. Drug Y is used in combination with: (Select one). [multiple myeloma conditions only]

Value
Value Label
01
dexamethasone
02
platinum-based chemotherapy
03
radiation
99
Don’t know
-99
Refused

//NEW SCREEN//
Question type: Single punch
Q7. Can [Drug X/Drug Y] be used before trying other cancer treatments? 

Value
Value Label
01
Yes [Skip Q8]
00
No [Ask Q8]
99
Don’t know [Skip Q8]
-99
Refused [Skip Q8]

//NEW SCREEN//
Question type: Single punch
Q8. [Drug X, Drug Y] is used after trying: (Select one).

Value
Value Label
01
at least three prior medicines
02
platinum-based chemotherapy
03
radiation
99
Don’t know
-99
Refused

//NEW SCREEN//
Question type: Single punch
[Randomize order of Q9-Q11]

Variable
Non-small cell lung cancer conditions
Multiple myeloma conditions
Q9.
Michael (age 49) was recently diagnosed with non-small cell lung cancer and has not been treated for it yet. Is he a good candidate for taking Drug X?
Michael (age 49) was recently diagnosed with multiple myeloma and has not been treated for it yet. Is he a good candidate for taking Drug Y?
Q10. 
Kara (age 42) has non-small cell lung cancer, but hasn’t had a genetic test. She previously treated her cancer with platinum-based chemotherapy. Is she a good candidate for taking Drug X?
Kara (age 42) has multiple myeloma. She’s allergic to dexamethasone. Is she a good candidate for taking Drug Y?
Q11.
Janelle (age 57) has non-small cell lung cancer. Her doctor told her she has a certain type of ALK gene. She’s previously treated her cancer with platinum-based chemotherapy. Is she a good candidate for taking Drug X?
Janelle (age 57) has multiple myeloma. She’s previously tried three different medicines to treat it. Is she a good candidate for taking Drug Y?

Value
Value Label
01
Yes
02
No
99
Don’t Know
-99
Refused


//NEW SCREEN//
Question Type:  Single Punch 
 [Randomize order of Q12 responses; last response should always appear last.]

Q12. Who would [Drug X, Drug Y] be appropriate for? Select one response.

Variable
Non-small cell lung cancer conditions
Multiple myeloma conditions
Q12_A
All adults with non-small cell lung cancer.
All adults with multiple myeloma.
Q12_B
Adults with non-small cell lung cancer, but only if they’ve previously been treated with platinum-based chemotherapy.
Adults with multiple myeloma, but only if they’ve received at least three prior medicines to treat it.
Q12_C
Adults with non-small cell lung cancer, but only if they have a certain type of ALK gene.
Adults with multiple myeloma who can take it in combination with dexamethasone.
Q12_D
Adults with non-small cell lung cancer, but only if they’ve previously been treated with platinum-based chemotherapy and have a certain type of ALK gene.
Adults with multiple myeloma, but only if they’ve received at least three prior medicines to treat it and can take it in combination with dexamethasone.
Q12_E
Don’t know.
Don’t know.

//NEW SCREEN//
Question type: Single punch
Q12B. One criterion for taking [Drug X, Drug Y] is that you have to have a certain type of ALK gene. 

Value
Value Label
01
True
02
False
99
Don’t know
-99
Refused

//NEW SCREEN//
BEHAVIORAL INTENTIONS
Q101a. If a loved one was diagnosed with [non-small cell lung cancer, multiple myeloma], how likely are you to mention [Drug X, Drug Y] to him/her?

Value
Value Label
01
1 Not at all likely
02
2 Slightly likely
03
3 Somewhat likely
04
4 Very likely  
-99
Refused

//NEW SCREEN//
 [If Q101a>01, ask Q101b]
Q101b. If a loved one was diagnosed with [non-small cell lung cancer, multiple myeloma], I would suggest that they ask their doctor about (check all the apply):

[Randomize order]
Value
Value Label
00
Taking [Drug X, Drug Y]
01
[Drug X, Drug Y]’s risks
02
[Drug X, Drug Y]’s benefits
-99
Refused

//NEW SCREEN//
Question Type:  Single Punch 
Q13. Did you see or hear this statement in the ad? 

Statement: [Display this statement in non-small cell lung cancer conditions]
Drug X is for adults with advanced non-small cell lung cancer previously treated with platinum-based chemotherapy, who have a certain type of ALK gene.

Statement: [Display this statement in multiple myeloma conditions]
Drug Y is used to treat multiple myeloma in combination with dexamethasone, in adults who have received at least three prior medicines to treat multiple myeloma.

Value
Value Label
01
Yes 
02
No 
99
Don’t know 
-99
Refused

//NEW SCREEN//

Question type: Text Box
Pretest Q1. What does this statement mean to you? 

Statement: [Display this statement in non-small cell lung cancer conditions]
Drug X is for adults with advanced non-small cell lung cancer previously treated with platinum-based chemotherapy, who have a certain type of ALK gene.

Statement: [Display this statement in multiple myeloma conditions]
Drug Y is used to treat multiple myeloma in combination with dexamethasone, in adults who have received at least three prior medicines to treat multiple myeloma.

[Non-small cell lung cancer codes: not for everyone with non-small cell lung cancer/limited/restrictions, non-small cell lung cancer/NSCL, lung cancer, cancer, previously treated with platinum-based chemotherapy, previously treated in general, people who have a certain type of ALK gene, based on genetics generally, certain people generally, other codes to be determined based on cognitive interviews]

[Multiple myeloma codes: not for everyone with multiple myeloma/limited/restrictions, multiple myeloma, cancer, in combination with dexamethasone, with other drugs generally, people who have received at least three prior medicines, received prior treatment generally, other codes to be determined based on cognitive interviews]

//NEW SCREEN//
FAMILIARITY WITH CONDITION
Question Type:  Single Punch 
Q14. How familiar were you with treatments for [lung cancer, multiple myeloma] before today?

Value
Value Label
01
1 Not at all
02
2 A little bit
03
3 Somewhat
04
4 Quite a bit
05
5 Extremely
-99
Refused

Question Type: Single Punch 
Q15. Have you ever been diagnosed as having cancer?

Value
Value Label
01
Yes 
02
No (Skip to Q18)
-99
Refused

//NEW SCREEN//
Question Type: CHECKLIST 
Q16. What type of cancer did you have? (check all that apply) 
    • Bladder cancer
    • Bone cancer
    • Breast cancer
    • Cervical cancer
    • Colon cancer
    • Endometrial cancer
    • Head/neck cancer
    • Leukemia
    • Liver cancer
    • Lung cancer
    • Lymphoma (either Hodgkin’s or Non-Hodgkin’s)
    • Melanoma
    • Multiple Myeloma
    • Ovarian cancer
    • Pancreatic cancer
    • Pharyngeal cancer
    • Prostate cancer
    • Rectal cancer
    • Renal cancer
    • Skin cancer
    • Stomach cancer
    • Other cancer

Question Type: Single Punch 
Q17. Did you take one or more prescription drugs for your cancer?

Value
Value Label
01
Yes
02
No 
99
Don’t know
-99
Refused

//NEW SCREEN//
Q18. Are you currently caring for or making health care decisions for someone with cancer?

Value
Value Label
01
Yes 
02
No
-99
Refused

//NEW SCREEN//

SELF-REPORTED ATTENTION
[Q19 was adapted from Ju, I., Ohs, J. E., & Park, J. S. (2019). Consumer’s Regulatory Knowledge of Prescription Drug Advertising and Health Risk Awareness: The Moderating Role of Risk Information Prominence. Health Communication, 1-11.]

Question Type:  Single Punch 
Q19. How much attention did you pay to the information about who can take [DRUG X, DRUG Y]?

Value
Value Label
01
1 No attention
02
2 Very little attention
03
3 Some attention 
04
4 A great deal of attention
-99
Refused

//NEW SCREEN//
AD CONFUSION
[Randomize order of Q20-Q21]

Question Type:  Single Punch 
Q20. The information in the ad was easy to understand.

Value
Value Label
01
1 Strongly disagree
02
2 Disagree
03
3 Agree
04
4 Strongly agree
-99
Refused

Question type: Single punch
Q21. The information in the ad was confusing.

Value
Value Label
01
1 Strongly disagree
02
2 Disagree
03
3 Agree
04
4 Strongly agree
-99
Refused

//NEW SCREEN//
TELEVISION VIEWING

Question type: Single punch
Q22a. In a typical week, how many hours of television do you watch?

__­­__ Hours

[If Q22a>00, ask Q22b]
Question type: Single punch
Q22b. Do you watch the commercials when you watch TV?

Value
Value Label
01
Yes, always
02
Yes, sometimes 
03
No, I change the channel
04
No, I don’t pay attention to commercials
05
No, I don’t watch TV with commercials
-99
Refused

[If Q22b>02, ask Q22c]
Question type: Single punch
Q22c. Where are you most likely to watch advertisements? Choose the best response. 

Value
Value Label
01
While watching something on broadcast television stations (for example, NBC, ABC, CBS, FOX, PBS)
02
While watching something on cable television stations (for example, ESPN, MSNBC, HBO, E!) 
03
While watching shows through streaming services (for example, Netflix, Hulu, Amazon Prime Streaming, Sling)
-99
Refused

//NEW SCREEN//

DEBRIEF
 
[Drug X, Drug Y] is not a real product and is not available for sale. 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. Please see your health care professional for questions about [lung cancer, multiple myeloma].


You have been very helpful. Thank you very much for your participation!