Study 2

Study of Oncology Indications in Direct-to-Consumer Television Advertising

Appendix D - Study 2 Questionnaire

Study 2

OMB: 0910-0885

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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 showWe’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!


19


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AuthorSullivan, Helen W (CDER)
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File Created2021-01-14

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