Study of Comparative Effectiveness of Disease Education Messaging

WebMD Assessment Tool

Celebrity Test/Study of Comparative Effectiveness of Disease Education, V4

Paperwork Reduction Act

No. 0910-0847

Expiration Date: 11/30/2020

Paperwork Reduction Act Statement

Public reporting burden for this collection of information is estimated to be 10 minutes, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden, to PRAStaff@fda.hhs.gov.  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.

Your participation/nonparticipation is completely voluntary, and your responses will not have an effect on your eligibility for receipt of any FDA services. In instances where respondent identity is needed (e.g., for follow-up of non-responders), this information collection fully complies with all aspects of the Privacy Act and data will be kept private to the fullest extent allowed by law.

Screening Questions

1. What is your age? Enter number.

____ age in years RANGE 1-100; TERMINATE IF <18

2. What is your gender?

ROTATE

1. Male

2. Female

3. Which of the following statements best describes you? Please select one.

1. I had/have been diagnosed with cancer

2. I am responsible for the care of someone who had/has been diagnosed with cancer

3. A loved one, friend, or relative had/has been diagnosed with cancer

4. None of the above (QUOTA, N=100)

PIPE IN PHRASE ON LEFT IF “DIAGNOSED” IN S3, PHRASE ON RIGHT IF “CAREGIVER” OR “LOVED ONE” IN S3.

4. Which of the following type(s) of cancer [have you/has your loved one] been diagnosed with?

1. Bladder cancer

2. Brain tumor

3. Breast cancer

4. Cervical cancer

5. Colon cancer

6. Gastric (stomach) cancer

7. Kidney cancer

8. Leukemia

9. Lung cancer

10. Lymphoma

11. Multiple myeloma

12. Ovarian cancer

13. Pancreatic cancer

14. Skin cancer

15. Thyroid cancer

16. Other type of cancer not listed above

5. How long ago [were you/was your loved one] diagnosed with INSERT FROM S4?

1. Less than 6 months ago

2. 6 months to less than 1 year

3. 1 to less than 2 years

4. 2 to less than 5 years

5. 5 to less than 10 years

6. 10 years or more

6. According to your physician, at what stage is [your/your loved one’s] INSERT FROM S4?

1. Stage 0

2. Stage I

3. Stage II

4. Stage III

5. Stage IV/Metastatic

6. In remission

7. Don’t know

ASK S7 IF S3=”DIAGNOSED”

7. Please rate how confident you feel about each of the following statements as it relates to [your/your loved one’s] cancer treatment, where “1” is not at all confident and “7” is extremely confident.

SHOW SCALE

Not at all confident						Extremely confident
1	2	3	4	5	6	7

ROTATE

1. [I am/My loved one is] receiving the best care right now

2. I can work with doctors to make important treatment decisions for [myself/my loved one]

3. [I/My loved one] can keep the disease-induced emotional distress from interfering with relationships

4. [I have/My loved one has] the knowledge to choose the best treatment

5. [I/My loved one] can do things other than just taking medication to reduce side effects

6. [I/My loved one] can talk to my doctor about clinical trials

NEXT SCREEN

Clinical Trial Experience

In this section of the tool we will ask you some questions about clinical trials. For the purposes of this study, clinical trials are:

Research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people. Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment.

1. Which of the following best describes [your/your loved one’s] experience with clinical trials for cancer treatment? Please select one.

SINGLE-PUNCH

1. Have participated in a clinical trial for cancer treatment

2. Have been referred to a clinical trial for cancer, but did not participate

3. Have discussed clinical trials for cancer with doctors or other healthcare professionals, but did not participate

4. Have heard of clinical trials for cancer, but not familiar with them

5. Not at all familiar with clinical trials for cancer

NEXT SCREEN

Behaviors and Participation Intent

ASK B1 TO “EXPOSED GROUP” ONLY

1. Which of the following topics do you recall viewing on WebMD?

ROTATE; MULTI-PUNCH

1. Clinical trials

2. Cancer treatments

3. Immunotherapies

4. Diet and weight management

5. Cold and flu remedies

6. Medication side-effects

7. Other ANCHOR

2. How knowledgeable are you about clinical trials for cancer treatment?

SHOW SCALE

Not at all knowledgeable						Extremely knowledgeable
1	2	3	4	5	6	7

ASK B3 TO “DIAGNOSED” (S3=A)

3. How willing would you be to participate in a clinical trial for cancer treatment?

SHOW SCALE

Extremely unwilling			Neither willing nor unwilling			Extremely willing
1	2	3	4	5	6	7

ASK B4 TO B3>4

4. Which of the following statement(s) best explains why you would be willing to participate in clinical trials? Please select all that apply.

ROTATE, MULTI-PUNCH

1. I want to help find a cure or a better treatment

2. My current treatment is ineffective

3. I might have access to treatment or medication that isn’t available yet

4. I might get better attention and care from doctors and other healthcare professionals

5. I might get medication that is free or low cost

6. I might receive monetary compensation

7. Other ANCHOR; DO NOT FORCE ANSWER

8. None of the above ANCHOR; EXCLUSIVE

ASK B5 TO B3<5

5. Which of the following statement(s) best explains why you would be unwilling to participate in clinical trials? Please select all that apply.

ROTATE

1. I am satisfied with my current treatment

2. I am concerned about the potential risks if I participate in an experimental treatment

3. It is inconvenient for me to travel

4. I do not have the time to participate

5. I do not know enough about what’s involved in a clinical trial

6. I am unsure of the costs involved in participating in a clinical trial

7. Other ANCHOR; DO NOT FORCE ANSWER

8. None of the above ANCHOR; EXCLUSIVE

ASK B5 TO S3=B OR C

6. How likely are you to recommend participation in a clinical trial for cancer to your loved one diagnosed with cancer?

SHOW SCALE

Extremely unlikely			Neither likely nor unlikely			Extremely likely
1	2	3	4	5	6	7

ASK B6 TO EVERYONE

7. How likely are you to talk to your doctor or other healthcare professional about clinical trials for cancer treatment?

SHOW SCALE

Extremely unlikely			Neither likely nor unlikely			Extremely likely
1	2	3	4	5	6	7

8. Which of the following best describes your understanding of clinical trials for cancer treatment? Select all that apply.

ROTATE

1. Clinical trials can find treatments that are better than what’s currently available

2. Clinical trials can help find ways to prevent and detect cancer

3. Clinical trials can help improve the quality of life for people during and after cancer treatment

4. You can still learn from clinical trials, even if clinical trial results show that the clinical trial drug is not more effective than standard treatments

5. Clinical trials are only for people who have advanced cancer that is not responding to treatment

6. Very few cancer patients participate in clinical trials

7. Everyone responds the same way to a drug or treatment in a clinical trial

8. None of the above ANCHOR; EXCLUSIVE

ASK CONTENT EVALUATION TO “EXPOSED GROUP” ONLY

NEXT SCREEN

Content Evaluation

PIPING BASED ON WHETHER RECRUITED FROM VIDEO OR ARTICLE

1. Do you recall [watching a video / viewing an article] about clinical trials for cancer treatment on WebMD?

ROTATE

1. Yes

2. No SKIP TO DEMOGRAPHICS

2. To the best of your knowledge, who presented the information in the [video / article] you just viewed about clinical trials for cancer treatment?

_____ OPEN-END; FORCE ENTRY

3. How would you describe the person who presented the information in the [video / article] you just viewed?

ROTATE, SINGLE-PUNCH

1. They were a celebrity

2. They were a scientist

3. They were a government expert

4. Not sure ANCHOR

4. To what extent did you like or dislike the person presenting the information in the [video / article] you viewed about clinical trials for cancer treatment?

SHOW SCALE

Disliked very much			Neither liked nor disliked			Liked very much
1	2	3	4	5	6	7

5. Thinking about the content presented in the [video / article] you just viewed about clinical trials for cancer treatment, which of the following words do you associate most with the content? Select all that apply.

ROTATE

1. Attention-getting

2. Appealing

3. Authoritative

4. Boring

5. Clear

6. Convincing

7. Genuine

8. Informative

9. Inspiring

10. Irritating

11. Memorable

12. Offensive

13. Persuasive

14. Relatable

15. Unique

6. Thinking about the person who presented the content in the [video / article] you just viewed about clinical trials for cancer treatment, which of the following words do you associate most with the person? Select all that apply.

ROTATE

1. Attention-getting

2. Appealing

3. Authoritative

4. Boring

5. Clear

6. Convincing

7. Genuine

8. Informative

9. Inspiring

10. Irritating

11. Memorable

12. Offensive

13. Persuasive

14. Relatable

15. Unique

7. How likely are you to share the information you viewed about clinical trials with a loved one, friend or relative?

SHOW SCALE

Extremely unlikely			Neither likely nor unlikely			Extremely likely
1	2	3	4	5	6	7

8. To what extent, if any, has your understanding of clinical trials improved after viewing this information on WebMD?

SHOW SCALE

Not at all improved						Significantly improved
1	2	3	4	5	6	7

Respondent Demographics

1. Are you of Hispanic or Latino background? (Select one)

1. Yes

2. No

3. Prefer not to answer

2. How would you describe your race? (Select one)

ROTATE

1. Black/African American

2. Native American/American Indian/Alaskan Native

3. Asian

4. White/Caucasian

5. Native Hawaiian or Pacific Islander

6. Mixed race ANCHOR

7. Prefer not to answer ANCHOR

3. Which of the following best describes the highest level of education you have completed?

1. Some high school or less

2. High school graduate/GED

3. Technical/vocational school

4. Some college

5. College graduate

6. Post graduate

4. What is your approximate household income before taxes?

1. Less than $50,000

2. $50,000 to $74,999

3. $75,000 to $99,999

4. $100,000 to $199,999

5. $200,000 or more

6. Decline to answer

5. In which state or U.S. territory do you live?

[Please include drop down of 50 states plus District of Columbia and “other--u.s. territory or proctectorate” and code into the categories below.]

1. Northeast (ME, NH, VT, MA, CT, RI)

2. Mid Atlantic (WV, VA, DE, MD, DC, NC, PA, NY, NJ)

3. Great Lakes (OH, MI, IN, IL, WI, MN)

4. Southeast (SC, GA, FL, AL, MS, LA, TN, KY)

5. South Central (TX, OK, AR)

6. Southwest (AZ, UT, CO, NM, NV)

7. North Central (IA, MO, KS, NE, SD, ND)

8. Northwest (MT, WY, ID, OR, WA)

9. West (CA, AK, HI)

10. Other—U.S. territory or protectorate