Cognitive Interviews

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

Appendix D - Study 2 Questionnaire

Cognitive Interviews

OMB: 0910-0885

Document [docx]
Download: docx | pdf





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.


Please complete the survey in one sitting (without taking any breaks) to avoid distractions. If you leave the survey prior to finishing it, you will not be able to return to it. 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 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.


One of the 2 main types of lung cancer is called non-small cell lung cancer.

About 80% to 85% of lung cancers are non-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//


Before beginning the survey, please complete a brief audio and video test. Make sure your computer or tablet audio is on with the volume turned up, then click the Next button to start the audio and video test.


//NEW SCREEN//


[SINGLE PUNCH]

VIDCHECK Were you able to see the video we just showed you?

Value

Value Label

01

Yes

02

No [Terminate]


[SINGLE PUNCH]

AUDIOCHECK Which of the following sounds did you hear in the video?

Value

Value Label

01

Car horn honking [Terminate]

02

Birds chirping [Terminate]

03

Music playing

04

None of the above [Terminate]


//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.


  • 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


Question type: Single punch

Q2B. What does [Drug X, Drug Y] treat?

Value

Value Label

01

Lung cancer

02

Rheumatoid arthritis

03

Multiple myeloma

04

Bladder cancer

99

Don’t know

-99

Refused [Skip Q4]


//NEW SCREEN//


Question type: Single punch

Q3. Based on the ad for [Drugx/Drug Y], can any patient with [non-small cell lung cancer, multiple myeloma] take this drug?


Value

Value Label

01

Yes, any patient with {non-small cell lung cancer / multiple myeloma} can take it. [Skip Q4]

00

No, only patients with {non-small cell lung cancer / multiple myeloma} who meet certain guidelines can take it. [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]?


(Please be as detailed and specific as possible when entering your answer in the space provided.)


Only {non-small cell lung cancer / multiple myeloma} patients who… 




[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//



[RANDOMIZE WHETHER SOMEONE IS SHOWN Q12 FIRST AND THEN Q9-11 OR Q9-11 FIRST AND THEN Q12]


//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 62) has non-small cell lung cancer, but a genetic test found she does not have an ALK gene. 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 and she is not allergic to dexamethasone. 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

Q13. This statement may or may not have been in the ad you viewed. Do you think this statement was in the ad you viewed?


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, I think it was in the ad

02

No, I don’t think it was in the ad

99

I’m not sure if it was in the ad

-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//


//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. On a typical day, approximately how many hours do you spend watching television (including content streamed online)?


Value

Value Label

01

Less than 1 hour

02

1 to 2 hours

03

3 to 4 hours

04

5 hours or more

99

Don’t know

98

Refused



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



//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!


16


File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorSullivan, Helen W (CDER)
File Modified0000-00-00
File Created2021-04-06

© 2024 OMB.report | Privacy Policy