8 Attach 20B BEEA CATI Screen for RANDOM Group

Attachment 20B: BEEA CATI for Recently Exposed Participants

Study of Biomarkers of Exposures and Effects in Agriculture

C

OMB #: 0925-0406

Expiration date: 10/31/2011

Public reporting for this collection of information is estimated to average twenty minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. 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. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0406). Do not return the completed form to this address.

ATI Eligibility Screener Script (Recent Exposed Group)

Hello, I am trying to reach (APPLICATOR’S FIRST, MIDDLE INITIAL, LAST, SUFFIX).

IF THE PESTICIDE APPLICATOR IS NOT AVAILABLE NOW, ASK ABOUT AND RECORD A BETTER TIME TO REACH HIM.

IF ASKED “WHO IS CALLING?” BEFORE YOU GET TO THE RESPONDENT:

This is _________________. I am calling from a health study. This number is the number Mr. (First/Last Name) gave us to use to contact him. Is he there? Thank you very much.

TO RESPONDENT:

Am I speaking to (APPLICATOR’S FIRST, MIDDLE INITIAL, LAST, SUFFIX)?

Hello, my name is _________________. I am calling from the Agricultural Health Study (at the University of Iowa). You should have received a letter from (Dr. Charles Lynch/Mr. Charles Knott), Study Director in (Iowa/North Carolina) recently, to let you know that I would be calling. Do you recall seeing that in your mail? (PAUSE FOR RESPONSE)

Do you have a moment now to talk with me about that project?

CALL BACK: Record better day and better time.

TOO BUSY: This initial phone call will take only about 10 minutes. We can schedule for a better time (NOTE TIME). Or if you would like, we could get started and see how it goes. You could stop me at any time. Would that be OK?

REFUSING: (Try to respond to concerns.)

NOTE: CATI TO START HERE – INTERVIEWER WILL FIRST INDICATE IN CATI WHETHER RESPONDENT IS STILL REFUSING OR IS ALLOWING THE CONTACT TO CONTINUE.

S TILL REFUSING: Go to Additional Questions (Direct Refusal).

IF CONTINUING CONTACT:

Thank you. First let me make certain that I have reached the correct individual.

C1. Is your name (First/Last Name) and is your date of birth (Birthdate)?

1. Y es Go to Eligibility Questions

2. No

C2. What is your correct date of birth? ______/_______/________

MM DD YYYY

C3. [INTERVIEWER] IS IT POSSIBLE THAT THE NUMBERS IN THE DATE OF BIRTH FROM OUR RECORDS (BIRTHDATE), COMPARED TO THE BIRTHDATE GIVEN (RESPONDENT BIRTHDATE) COULD HAVE BEEN TRANSPOSED, MISREAD, OR ARE REVERSED?

1. Y ES Go to Eligibility Questions

2. NO

3. N OT SURE THANK YOU FOR YOUR HELP. I’LL PROVIDE THIS INFORMATION TO MY SUPERVISOR.

C4. Does another person with a similar name but a different date of birth live there?

1. Yes

2. No (QC5)

C4a. May I please speak to the other (FULL NAME)?

1. Y es THANK INITIAL/INCORRECT RESPONDENT; WAIT TO RECORD “YES” WHEN THE RESPONDENT IS ON THE PHONE.

2. No

C4b. Do you know a better time when we can reach the other (FULL NAME)?

________________________________________

Record information on how to reach (collect phone and best time to reach); then go to Closings.

C5. Do you know how we can reach the other (FULL NAME)?

________________________________________

Record information on how to reach (collect phone and best time to reach); then go to Closings.

ELIGIBILITY QUESTIONS

Thank you. I’m calling you today about a new project with the Agricultural Health Study. This part of the Agricultural Health Study is designed to directly measure biologic effects that may be related to various farming activities and exposures, would involve several visits to your farm during the year by people who specialize in this type of research. I’m happy to tell you that we do have some money to pay you for your participation.

To determine if you are eligible, I need to learn more about you and your plans for farming and applying pesticides this year. Again, please know that your answers are confidential, and that you may refuse to answer any particular question.

E1. Before we go any further, how likely is it that a chemical or product containing diazinon, either alone or in mixtures, will be applied to your crops during this year? Some pesticide brands that contain diazinon are Basudin and Spectracide. Is it:

1. Certain that it will be applied,

2. Possible that it will be applied, or

3. U nlikely or absolutely won't be applied?

4. D k Go to E4 (RANDOM SELECT GROUP)

5. Refused

E2. When using diazinon, do you usually mix, load, or apply the pesticide yourself?

1. Yes

2. N o

3. D k Go to E4 (RANDOM SELECT GROUP)

4. Ref

E3. In what month do you think you will (apply/make a decision about applying) diazinon?

1. Month |___|___|

2. DK

3. Ref

E4. According to your birthdate that we have on record, you should be (see age of AHS private pesticide applicator on front of call sheet) years old. Is this accurate?

1. Y es Go to E6

2. No

3. Dk

4. Ref

E5. What is your current age? ___________

IF less than 50 years old, go to INELIGIBLE 1 statement. IF 50 years old or older, continue:

E6. Do you have a blood clotting disorder such as hemophilia?

1. Y es Go to Ineligible 2

2. No

3. Dk

4. Ref

E7. In the last three years, other than non-melanoma skin cancer, have you been diagnosed by a doctor with any type of cancer?

1. Yes

2. N o

3. D k Proceed to END OF ELIGIBILITY INTERVIEW

4. Ref

E8. In what organ or part of the body did your cancer start? (If you are not sure of the answer, please give me your best guess.)

_____________________________ ____________________________

E9. In what year were you first diagnosed by a doctor with this cancer?

YEAR: |___|___|___|___|

Go to Ineligible 3

END OF ELIGIBILITY INTERVIEW

IF “ELIGIBLE FOR RECENT EXPOSURE GROUP”: Based on your answers, you are eligible for this part of the Agricultural Health Study. Did you have a chance to read the study fact sheet that was enclosed with the letter you received from [Dr. Lynch/Mr. Knott]? Do you have any questions about this study? [IF NOT, OR IF SUBJECTS HAS QUESTIONS; READ INFORMATION FROM FACT SHEET]

Would you be willing to participate in this study?

1. Yes

2. No

Refusing: Do you have any questions or concerns about the study that you would like to speak to one of the researchers about? [TRY TO ALLEVIATE CONCERNS OR SCHEDULE TIME TO TALK TO NCI RESEARCHERS]

S till Refusing Go to Additional Questions (Participating/Ineligible/Indirect Refusal)

IF “YES”: Thank you. This study involves a series of three visits to your home: one in the off-season, one within a day after you complete diazinon use, and one about three weeks after you complete diazinon use. Can I schedule a time during (MONTH) or (MONTH) for the first visit?

Record date and time of visit: Date: ___/___/_____ Time: ______am or pm

A1. Let me verify your street address. Is it (READ ADDRESS, CITY, STATE, AND ZIP CODE)?

1. Y es Go to Additional Questions (Participating/Ineligible/Indirect Refusal)

2. No

A2. What is the address of your current residence?

__________________________________________________________________________________________________________________________________________________________________________________________________________________

P roceed to Additional Questions (Participating/Ineligible/Indirect Refusal)

IF ELIGIBLE FOR RANDOM SELECT GROUP: Based on your answers, you are eligible for this part of the Agricultural Health Study. Did you have a chance to read the study fact sheet that was enclosed with the letter you received from [Dr. Lynch/Mr. Knott]? Do you have any questions about this study?[IF NOT, OR IF SUBJECTS HAS QUESTIONS; READ INFORMATION FROM FACT SHEET]

Would you be willing to participate in this study?

1. Yes

2. No

Refusing: Do you have any questions or concerns about the study that you would like to speak to one of the researchers about? [TRY TO ALLEVIATE CONCERNS OR SCHEDULE TIME TO TALK TO NCI RESEARCHERS]

S till Refusing Go to Additional Questions (Participating/Ineligible/Indirect Refusal)

IF “YES”: Thank you. This study would involve a visit to your home on a date that is convenient for you. Can I schedule a time during (MONTH) or (MONTH) for the visit?

Record date and time of visit: Date: ___/___/_____ Time: ______am or pm

B1. Let me verify your street address. Is it (READ ADDRESS, CITY, STATE, AND ZIP CODE)?

3. Y es Go to Additional Questions (Participating/Ineligible/Indirect Refusal)

4. No

B2. What is the address of your current residence?

__________________________________________________________________________________________________________________________________________________________________________________________________________________

P roceed to Additional Questions (Participating/Ineligible/Indirect Refusal)

INELIGIBLE 1: I apologize. Our records indicated that you were within the age range we are including in the study. However, based on this updated information on your age, you are not eligible for this part of the Agricultural Health Study. Go to Additional Questions (Participating/Ineligible/Indirect Refusal).

INELIGIBLE 2: Unfortunately, you are not eligible for this part of the Agricultural Health Study: we are looking for a group of men who are able to provide blood samples. Go to Additional Questions (Participating/Ineligible/Indirect Refusal).

INELIGIBLE 3: Unfortunately, you are not eligible for this part of the Agricultural Health Study: we are looking for a group of men who have never been diagnosed with cancer. Go to Additional Questions (Participating/Ineligible/Indirect Refusal).

ADDITIONAL QUESTIONS

Direct REFUSAL:

Thank you, I understand. Would you have time to answer a few quick questions about health screening for us? It will take about two minutes of your time, if that.

R EFUSAL: Go to Closings

IF ”YES”, continue:

Thank you. First let me make certain that I have reached the correct individual.

C1. Is your name (Full Name) and is your date of birth (Birthdate)?

1. Y es Go to Additional Questions Intro

2. No

C2. What is your correct date of birth? ______/_______/________

MM DD YYYY

C3. [INTERVIEWER] IS IT POSSIBLE THAT THE NUMBERS IN THE DATE OF BIRTH, HAVE BEEN TRANSPOSED, MISREAD, OR ARE REVERSED?

1. Y ES Go to Eligibility Questions

2. NO

3. N OT SURE THANK YOU FOR YOUR HELP. I’LL PROVIDE THIS INFORMATION TO MY SUPERVISOR.

C4. Does another person with a similar name but a different date of birth live here?

3. Y es Ask to speak to correct individual and/or how to reach him (collect phone and best time to reach); then go to Closings.

4. No

C5. Do you know how we can reach him? ________________________________________

1. Y es Ask to speak to correct individual and/or how to reach him (collect phone and best time to reach); then go to Closings.

2. N o Go to Closings

PARTICIPATING OR INELIGIBLE OR INDIRECT REFUSAL:

Before we finish, would you have time to answer three more quick questions about health screening for us? It will take about two minutes of your time, if that.

R EFUSAL Go to Closings

IF ”YES”, continue:

ADDITIONAL QUESTION INTRO:

These questions are aimed toward improving our understanding of cancer screening practices among participants in the Agricultural Health Study, and they are a separate part of the sub-study. As always, your answers are confidential, and you may refuse to answer any particular question.

1. Have you ever had a blood test for prostate cancer, for example PSA? Would you say:

1. Never,

2. Once, or

3. More than once?

4. DK

5. REF

2. Have you ever had a digital rectal examination of the prostate? Would you say:

1. Never,

2. Once, or

3. More than once?

4. DK

5. REF

3. Have you ever had a colonoscopy or sigmoidoscopy to examine the colon and rectum?

1. Never,

2. Once, or

3. More than once?

4. DK

5. REF

CLOSINGS

ELIGIBLE, WILLING TO PARTICIPATE:

Thank you. Those are all the questions I have for you today. About four weeks before your home visit, we will mail an appointment confirmation letter and materials for you to review and prepare for the visit. Meanwhile, please contact us at (800-217-1954/800-424-7883) if you have any questions about this study. We sincerely appreciate all of your help with our research.

INELIGIBLE:

Thank you for your time today and thanks again for taking part in the Agricultural Health Study.

REFUSAL:

Thank you for your time today and thanks again for taking part in the Agricultural Health Study.

RECORD REASON FOR REFUSAL.

____________________________________________________________________________________________________________________________________________________________________________________________________________________________________

NOT CORRECT RESPONDENT:

I’m sorry for the confusion. That is all the questions I have for you at this time. Thank you for speaking with me today.

Recently Exposed Group Intro/Eligibility Script 17 v. 3-31-2010