Focus Groups on Oncology Indications

Focus Groups Screening Questionnaire

Prescription Drug Perspectives

	St. Louis, MO (Midwest)	Atlanta, GA (South)	Philadelphia, PA (East)	Los Angeles, CA (West)
Endpoint Disclosure Groups	1 group of 9 with 13 recruits (cancer diagnosis)	1 group of 9 with 13 recruits (general public)	1 group of 9 with 13 recruits (cancer diagnosis)	1 group of 9 with 13 recruits (general public)
Clinical Endpoint Terminology Groups	1 group of 9 with 13 recruits (general public)	1 group of 9 with 13 recruits (cancer diagnosis)	1 group of 9 with 13 recruits (general public)	1 group of 9 with 13 recruits (cancer diagnosis)

SCRIPT

Hello, this is _____________ from [RECRUITMENT FIRM NAME], a market research firm. May I please speak to_____________?

Hello. We are working with RTI International, a nonprofit research organization on a research study with [INSERT SEGMENT] and would like to include your opinions. This research is being conducted on behalf of the U.S. Food and Drug Administration (FDA). The focus groups are about the ways that cancer treatments are talked about.

We are holding a focus group on [DATE]. The focus group starts at [TIME] and will last about 60 minutes. The discussion will be audio recorded, and project team members may observe the discussion in person or remotely (via live-streaming). You will be given $75 as a token of appreciation for taking part in this study.

Can I ask you a few questions now to see if you qualify?

Yes – Continue.

No – Thank and end call.

1. Have you ever been diagnosed with cancer?

Yes  Continue to 1B.

No  CONTINUE FOR GENERAL PUBLIC GROUP AND GO TO 2

1B. What type of cancer have you been diagnosed with? ________ Do not read the list out loud. Review the list below and code the response based on what the screening respondent says.

Skin cancer

• Skin cancer  TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]

• Basal cell carcinoma  TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]

• Kaposi's sarcoma  Assign to Solid Tumor group and continue to 1C

• Melanoma  Assign to Solid Tumor group and continue to 1C

• Merkel cell carcinoma  TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]

• Nonmelanoma skin cancer  TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]

• Squamous cell carcinoma  TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]

Other Common solid tumor cancers

• Bladder cancer

• Breast cancer

• Bone cancer

• Cervical cancer

• Colon & rectal

• Endometrial cancer

• Kidney cancer

• Lip & oral cancer

• Liver cancer

• Lung cancer

• Mesothelioma

• Non-small cell lung cancer

• Oral cancer

• Ovarian cancer

• Pancreatic cancer

• Prostate cancer

• Sarcoma

• Small cell lung cancer

• Thyroid Cancer

Blood or hematologic cancer

• Leukemia, includes Acute myeloid leukemia (AML)

• Chronic myeloid leukemia (CML)

• Acute lymphocytic (or lymphoblastic) leukemia (ALL)

• Chronic lymphocytic leukemia (CLL)

• Lymphoma, includes non-Hodgkin lymphoma, Hodgkin lymphoma Multiple myeloma

• Rule of thumb: If the participant selects anything other than the blood and hematologic types, assume they fall under solid tumor. But if you are unsure whether it classifies as a cancer or whether to place in solid tumor or hematologic group, write down the participant’s response and call RTI.

• If someone has been diagnosed with more than one type of cancer, place in whichever group—solid tumor or hematologic—has fewer confirmed recruits.

1C. Are you currently receiving treatment for your cancer? [If necessary, clarify that the respondent should have completed all treatment for his/her cancer, and not have any future treatments planned. Treatment may include chemotherapy, medication, and/or radiation therapy.]

Yes – TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]

No – CONTINUE FOR CANCER DIAGNOSIS GROUP AND RECRUIT MIX OF SOLID TUMOR AND BLOOD

1D. Did you ever participate in a clinical trial for your cancer?

• Yes  Continue

• No  Continue

2. Have you ever worked for …? [READ LIST]

Any office, division, or agency within the Department of Health and Human Services (HHS) TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]

A pharmaceutical company  TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]

A marketing or market research company  TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]

A healthcare company or in the healthcare field  TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]

3. When was the last time you participated in an interview or focus group? [READ LIST]

Never  Continue

More than 3 months ago  Continue

In the past 3 months  TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]

4. What is your gender? [RECRUIT A MIX]

Male

Female

Prefer No to Answer

5. Are you Hispanic, Latino/a, or of Spanish origin? [RECRUIT A MIX]

No

Yes

6. What is your race? [READ LIST IF NECESSARY AND RECRUIT A MIX]

White

Black or African American

Asian

Native Hawaiian or Other Pacific Islander

American Indian or Alaskan Native

[DON’T READ] Prefer Not to Answer

7. What is the highest level of education that you have completed? [READ LIST AND RECRUIT A MIX]

High school graduate, GED or less  Continue and recruit 6/15 for each group [this will be best effort for consumers diagnosed with cancer; if recruiting 12 or 13, aim to recruit 5 for each group]

Some college or 2-year degree  Continue

College degree  Continue

Postgraduate degree  Continue

8. On a scale of 1-5, with 1 being “not at all comfortable” and 5 being “extremely comfortable”, how comfortable are you with asking your doctor to explain something that you are confused about?

1-3  TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]

4-5  Continue

9. During the focus group discussion, you will be asked to review written materials and offer your opinions; therefore, I need to ask whether you have a medical or nonmedical condition that affects your ability to read and/or understand written materials in English.

Yes  TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]

No  Continue

10. For study purposes, if you participate, the focus group will be audio recorded and the video will be live streamed to study team members. Are you okay with us audio recording and live streaming the focus group?

Yes  Continue

No  TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]

Closing Scripts

Ineligible - Closing Script

I’m sorry, but you are not eligible for this study. There are many possible reasons why people are not eligible. These reasons were decided earlier by the researchers. However, thank you for your interest in this study and for taking the time to answer our questions today.

Eligible – Closing Script

Great! You qualify for our study. The discussion group will be held on [DATE] at [TIME] and will last about 60 minutes. You will receive $75 at the end of the focus group for your time and travel expenses.

Would you like to participate in the group discussion at [TIME] on [DATE]?

Yes – Continue to scheduling script.

No – Thank and end call.

Eligible – Scheduling script

May I please have your mailing and/or e-mail address and telephone number to send you a confirmation letter with directions for attending the focus group on [DATE/TIME]? We will use this information to send you a reminder letter and to call and remind you of the focus group. We will destroy all contact information at the conclusion of the focus groups. [Verify contact information]

Follow-up

**NOTE** THIS PAGE MUST BE STORED SEPARATELY FROM THE SCREENER AND DATA. PLEASE DESTROY UPON COMPLETION OF FOCUS GROUPS.

NAME: ____________________________________________________________

ADDRESS: ________________________________________________________

CITY: _________________________________________________

ZIP CODE: _________________________________________________

E-MAIL_______________________________________________________

What is the best time to reach you? What is the best telephone number to reach you at that time?

BEST TIME TO BE REACHED: ________________________________________

BEST PHONE NUMBER: ________________________________________

Is there another time and number we can try if we miss you?

ALTERNATE TIME:

ALTERNATE PHONE NUMBER:

Thank you. That’s all the questions I have today. If you have any questions or find that you are unable to attend, please call [recruiter’s phone number] as soon as possible. Thank you again for your time. We look forward to seeing you at [TIME] on [DATE].

Confirmation Email

Recipients: Recipients who agree to participate

Subject: You have been scheduled for a study – Confirmation

Body:

Dear <NAME>:

Thank you for signing up for a focus group about the ways that cancer treatments are talked about.

We really appreciate it. You have been scheduled for the following time slot: <Insert Study Time><Insert Study Date>

The study takes place at <Insert study location>. (See below for directions)

If you find you cannot attend or need to reschedule, please notify us immediately at <Insert facility phone number> or by email at <Insert facility email>.

We look forward to speaking with you then.

Kind regards,

<RECRUITER’S NAME>

<Signature line with phone number and email>

Directions to facility:

<Give direction to facility for location>

Confirmation Call Script

This is <RECRUITER’S NAME> calling from <NAME COMPANY/LOCAL FACILITY> and I’m trying to reach <PARTICIPANT NAME>. I am calling to you confirm your appointment with us for <Study Time> <Study Date>. Thank you for your time, and we’ll see you on <Study Date>.

OMB Control #0910-0677 Expires 05/31/2020