Study 1

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

Appendix C - Study 1 Questionnaire

Study 1

OMB: 0910-0885

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Oncology Indications Study 1 Questionnaire


[Screener and consent to be inserted]


INTRODUCTION


Thank you for agreeing to participate in this study today. We are going to show you an ad with information about 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.


//NEW SCREEN//


[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.


[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: overall survival, overall response rate, overall response rate with disclosure, progression-free survival, progression-free survival with disclosure]


[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]

[The audio claims to be tested were based on focus groups and may be refined during cognitive interviews. The audio claims are as follows:


Overall survival – solid tumor: In a clinical trial, patients taking Drug X lived an average of 4 months longer than patients on chemotherapy.


Overall response rate – solid tumor: In a clinical trial, 20% of patients taking Drug X had their tumors shrink or disappear, compared to 9% of patients on chemotherapy.


Progression-free survival – solid tumor: In a clinical trial, patients taking Drug X had an average of 4 months longer before their cancer grew or spread than patients on chemotherapy.


Overall survival – hematology: In a clinical trial, patients taking Drug Y in combination with dexamethasone lived an average of 4 months longer, compared to patients taking dexamethasone alone.


Overall response rate – hematology: In a clinical trial, 20% of patients taking Drug Y in combination with dexamethasone had a response such as fewer or no detectable cancer cells, compared to 9% of patients taking dexamethasone alone.


Progression-free survival – hematology: In a clinical trial, people taking Drug Y in combination with dexamethasone had an average of 4 months longer before their multiple myeloma got worse, compared to patients taking dexamethasone alone.


Disclosure: We currently do not know if [Drug X, Drug Y] helps people live longer.


//NEW SCREEN//

MANIPULATION CHECK


Question Type: Single Punch

Q1. Were you able to view the 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.”]


//NEW SCREEN//

UNDERSTANDING/RETENTION ITEMS


Question type: Text box

Q2. How can [Drug X, Drug Y] help people with [non-small cell lung cancer, multiple myeloma]?



[Open Field]


[Codes: cure, live longer but no cure, live longer, feel better/healthier, reduce symptoms, shrinks tumor/reduces cancer cells/improve response, extend interval between chemo, reduce cancer induced symptoms, reduce chemotherapy induced symptoms, remission, increases time without disease getting worse/cancer growing or spreading, healthier longer, less pain, other codes to be determined based on cognitive interviews and pretesting]


//NEW SCREEN//

Question Type: Grid

[Randomize order of Q3 A – F]

Q3. Based on the information in the ad, mark whether each of the statements below is true, false, or you don’t know:


Variable

Variable Text

Q3_A

[Drug X, Drug Y] can cure [non-small cell lung cancer, multiple myeloma].

Q3_B

[Drug X, Drug Y] can help people with [non-small cell lung cancer, multiple myeloma] live longer.

Q3_C

[Drug X, Drug Y] can help improve symptoms for people with [non-small cell lung cancer, multiple myeloma].

Q3_D

[Drug X, Drug Y] can help increase the amount of time before the [cancer grows or spreads, multiple myeloma gets worse].

Q3_E

[Drug X, Drug Y] can [help tumors shrink or disappear, help increase patients’ response to treatment, such as fewer or no detectable cancer cells].

Q3_F

[Drug X, Drug Y] can improve quality of life for people with [non-small cell lung cancer, multiple myeloma].


Value

Value Label

01

True

02

False

99

Don’t Know

-99

Refused


//NEW SCREEN//

DRUG RISKS AND BENEFITS


Question Type: Grid

[Randomize order: first (00) to last (02) or last to first]

Q4. Please select one response. Based on the information in the ad, which one of the following statements is true for people with [non-small cell lung cancer, multiple myeloma]?

Value

Value Label

00

On average, people who take [Drug X, Drug Y] live the same amount of time as people who do not take [Drug X, Drug Y].

01

On average, people who take [Drug X, Drug Y] live longer than people who do not take [Drug X, Drug Y].

02

We currently don’t know whether people who take [Drug X, Drug Y] live longer or not.

99

I don’t know

-99

Refused


[If Q4=02, ask Q5]


//NEW SCREEN//

Question type: Text Box (numbers, 3 separate fields)

Q5. You mentioned that [Drug X, Drug Y] would help people with [non-small cell lung cancer, multiple myeloma] live longer. On average, how much longer do you think people with [non-small cell lung cancer, multiple myeloma] who take [Drug X, Drug Y] would live? Your best guess is fine. (Please write a number in one of the spaces 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.)___ (There will be a dropdown box that people have to choose that has the following choices: weeks longer; months longer; years longer) [RANGE=0-100]



Value

Value Label

-99

Refused

-100

Valid skip



//NEW SCREEN//

QUALITY OF LIFE, SYMPTOM IMPROVEMENT, AND RISK


Question Type: Single Punch

Q6. The ad suggests that [Drug X, Drug Y] will:


Value

Value Label

01

1 Greatly reduce a person’s quality of life

02

2 Somewhat reduce a person’s quality of life

03

3 Somewhat improve a person’s quality of life

04

4 Greatly improve a person’s quality of life

05

The ad doesn’t suggest anything about quality of life.

-99

Refused


[Randomize order of Q7 – Q9]

Please indicate your level of agreement with the following statements.


//NEW SCREEN//

RISK-BENEFIT TRADEOFF

Question Type: Single Punch

Q7. The benefits of [Drug X, Drug Y] outweigh the side effects described in the ad.


Value

Value Label

01

1 Strongly disagree

02

2 Disagree

03

3 Somewhat disagree

04

4 Somewhat agree

05

5 Agree

06

6 Strongly agree

99

Don’t know

-99

Refused


RISK-BENEFIT TRADEOFF

Question Type: Single Punch

Q8. [Drug X, Drug Y] is more likely to harm than benefit someone with [non-small cell lung cancer, multiple myeloma].


Value

Value Label

01

1 Strongly disagree

02

2 Disagree

03

3 Somewhat disagree

04

4 Somewhat agree

05

5 Agree

06

6 Strongly

99

Don’t know

-99

Refused


RISK SEVERITY

Question Type: Single Punch

Q9. [Drug X, Drug Y] might have serious side effects.



Value

Value Label

01

1 Strongly disagree

02

2 Disagree

03

3 Somewhat disagree

04

4 Somewhat agree

05

5 Agree

06

6 Strongly

99

Don’t know

-99

Refused


//NEW SCREEN//

BEHAVIORAL INTENTIONS

Question Type: Single Punch


Q10a. 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 A little likely

03

3 Somewhat likely

04

4 Moderately likely

05

5 Very likely

06

6 Extremely

-99

Refused




//NEW SCREEN//

DISCLOSURE ATTENTION AND INTERPRETATION


Question Type: Single Punch

Q11 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:

We currently do not know if [Drug X, Drug Y] helps people live longer.


Value

Value Label

01

Yes, I think it was in the ad

02

No, I don’t think it was in the ad

03

I’m not sure if it was in the ad

-99

Refused


//NEW SCREEN//

Question type: Text Box

Q11b. What does this statement mean to you?


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


Statement:

We currently do not know if [Drug X, Drug Y] helps people live longer.


[Codes to be determined based on cognitive interviews and pretesting]


//NEW SCREEN//

FAMILIARITY WITH CONDITION


Question Type: Single Punch

Q12. 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

Q13. Have you ever been diagnosed as having cancer?


Value

Value Label

01

Yes

02

No (Skip to Q16)

-99

Refused


//NEW SCREEN//

Question Type: CHECKLIST

Q14. 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

Q15. 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//

Q16. 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//

TREATMENT ATTITUDES


Please indicate your level of agreement with the following statements.

[The next two questions were adapted from the Schedule of Attitudes toward Hastened Death (Rosenfeld et al., 2000). Included as a potential moderator.]


Question Type: Single Punch

Q17. If I was diagnosed with a life-threatening disease, I would want to continue living no matter how much pain or suffering my disease causes.


Value

Value Label

01

1 Strongly disagree

02

2 Disagree

03

3 Agree

04

4 Strongly agree

-99

Refused


Question Type: Single Punch

Q18. If I was diagnosed with a life-threatening disease, I would aggressively pursue all possible treatments because I’d do anything possible to continue living.


Value

Value Label

01

1 Strongly disagree

02

2 Disagree

03

3 Agree

04

4 Strongly agree

-99

Refused


//NEW SCREEN//

AD PERCEPTIONS

[Q20 targets ad perceptions, including feelings of hope, fear, worry and confusion. It was adapted from van der Meer, T. G., & Jin, Y. (2019). Seeking Formula for Misinformation Treatment in Public Health Crises: The Effects of Corrective Information Type and Source. Health communication, 1-16 and Nonnemaker, J. M., Choiniere, C. J., Farrelly, M. C., Kamyab, K., & Davis, K. C. (2014). Reactions to graphic health warnings in the United States. Health Education Research30(1), 46-56]


Question Type: Grid

[Randomize order of Q20A – I]

Q20. Think about the ad you just viewed. How much did the ad make you feel...?

Variable

Variable Text

Q20_B

Hopeful

Q20_C

Optimistic

Q20_E

Worried


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


//NEW SCREEN//

SELF-REPORTED ATTENTION


[Q21 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.]



//NEW SCREEN//

TELEVISION VIEWING


Q23. On a typical day, approximately how many hours do you spend watching television (including content streamed online)?


Question type: Single punch

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




//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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