Form 4 Liver Supplement

Resource for the Collection and Evaluation of Human Tissues and Cells from Donors with an Epidemiology Profile (NCI)

Attach 8 - Liver Study Questionnare - No.3

Liver Supplement

OMB: 0925-0623

Document [doc]
Download: doc | pdf

ID# __ - __ - ___ ___ ___ ___ ___ ___






LIVER CANCER STUDY


CASE AND HIGH RISK CASES QUESTIONNARE











National Cancer Institute

Building 37, Third Floor

Bethesda, Maryland 20892

Phone (301) 496-2048 Fax (301) 496-0497


University of Maryland School of Medicine

Bressler Building, Third Floor, Suite 3-006-C

655 West Baltimore Street

Baltimore, Maryland 21201-1509

Phone (410) 706-5129 Fax (410) 706-5173

__________________________________________________________________________

OMB# 0925-XXXX

Expiration Date: XX / XX / XXXX

Attachment # 8: Liver Case-Control Questionnaire

BURDEN STATEMENT:

Public reporting burden for this collection of information is estimated to average 30 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-XXXX). Do not return the completed form to this address.


PRIVACY STATEMENT:

Statement Of Privacy Act Applicability

You will be asked to participate in the research study “Resource Collection and Evaluation of Human Tissues from Donors with an Epidemiological Profile for NCI Contract # NO2-RC-2010-00117”. The study will collect and use health information that can identify you. The authority to collect this information is under 42 USC 285 for the National Cancer Institute, National Institutes of Health. The Privacy Act from 1974 applies to the information collection.

Federal laws require researchers to protect the privacy of your health information. The collection of health information by this study “Resource Collection and Evaluation of Human Tissues from Donors with an Epidemiological Profile for NCI Contract # NO2-RC-2010-00117” is covered by the Privacy Act and is in compliance with the Privacy Act System of Records Notice (SORN) # 09-25-0200 http://oma.od.nih.gov/ms/privacy/pa-files /0200, which covers clinical, basic, and population-based research studies of the National Cancer Institute and the National Institutes of Health








TABLE OF CONTENTS



A. IDENTIFIER SHEET………………………………………………………...


4

B. MEDICAL HISTORY …………………………………………...…………..


5

C. FAMILY HISTORY…………………………………………………………


7

D. ALCOHOL HISTORY……………………………………………………….


9

  1. TOBACCO HISTORY……………………………………………………….

11


E. REPRODUCTIVE HISTORY………………………………………………


13

G. GENERAL INFORMATION………………………………………………..


15

H. ADMINISTRATIVE INFORMATION…………………………………...


23

I. INTERVIEWER REMARKS………………………………………………...


23












All the information & the data collected in this study are confidential & will not be used except for scientific research.



  1. Date of interview: __ __ / __ __ / __ __ __ __


  1. Interviewer’s name: ___________________________ Interviewer’s ID __ __


  1. Hospital: ____________________________________


  1. Doctor’s Name: _______________________________


  1. Patient’s Medical Record #: _________________________________


  1. Patient’s Ethnicity: ( )1 Hispanic/Latino ( )2 Not Hispanic/Latino


  1. Patient’s Race: ( )1 White

( )2 Black/African American

( )3 Asian

( )4 Native Hawaiian/Other Pacific Islander

( )5 American Indian/Alaska Native


  1. Patient’s Gender: ( )1 Male

( )2 Female

  1. Time Started: __ __ : __ __ ( )1 AM

( )2 PM


__________________________________________________________________________


OFFICE USE ONLY


Review


Reviewer’s initials: __ __ __ Date Reviewed: __ __ / __ __ / __ __ __ __


Coding and Editing


Coder’s initials: __ __ __ Date Coded: __ __ / __ __ / __ __ __ __


Data Entry


First Entry Initials: __ __ __ Date Entered: __ __ / __ __ / __ __ __ __


Second Entry Initials: __ __ __ Date Entered: __ __ / __ __ / __ __ __ __


Revisions


Revisor’s initials: __ __ __ Date Revised: __ __ / __ __ / __ __ __ __

__________________________________________________________________________


A. IDENTIFIER SHEET


Now I would like to ask you some general information about you.



  1. What is your name? _________________/________________/_____________

First Middle Last

  1. What is your date of birth? __ __ / __ __ / __ __ __ __


  1. What is your address:



__________________________________________________________________

Street Apt. No.


_______________________ ___ ___ __ __ __ __ __ - __ __ __ __

City State Zip Code



  1. What is your telephone number? Home: (__ __ __) __ __ __ - __ __ __ __


Work: (__ __ __) __ __ __ - __ __ __ __


Ext. __ __ __ __


  1. Do you consider yourself Hispanic/Latino or Not Hispanic/Latino? ( )1 Hispanic/Latino ( )2 Not Hispanic/Latino


  1. Do you consider yourself to be: ( )1 White/Caucasian

( )2 Black/African American

( )3 Asian

( )4 Native Hawaiian/Other Pacific Islander

( )5 American Indian/Alaska Native

7. What is your age?

( )0 18-24 years ( )9 65-69 years

( )1 25-29 years ( )10 70-74 years

( )2 30-34 years ( )11 75-79 years

( )3 35-39 years ( )12 80-84 years

( )4 40-44 years ( )13 85-90 years

( )5 45-49 years

( )6 50-54 years

( )7 55-59 years

( )8 60-64 years


8. What is the name, address and telephone number of a person who can help us contact you in the future, or your next-of-kin (or person who was interviewed if other than patient)?

Name: _________________/________________/_____________

First Middle Last


Relationship to Patient: ( )0 Spouse

( )1 Parent

( )2 Child

( )3 Brother or Sister

( )4 Friend

( )5 Other -Specify ______________


Address:


__________________________________________________________________

Street Apt. No.


_______________________ ___ ___ __ __ __ __ __ - __ __ __ __

City State Zip Code



Home telephone number: (__ __ __) __ __ __ - __ __ __ __

TYPE OF STUDY PARTICIPANT: ( )0 Liver Cancer Case

( )1 High Risk patient/Hospital Control









B. MEDICAL HISTORY

Now I would like to ask some questions about your medical history and your health.


  1. Have you ever had a blood transfusion?

( )0 No (Skip to B.4)

( )1 Yes

( )8 Don’t know


  1. How many times have you had a blood transfusion in your life?

( )1 One time

( )2 2-4 times

( )3 5 times or more

( )8 Don’t know


  1. When was the last time you had a blood transfusion?


Year ___ ___ ___ ___

(calculate if he/she said how many years ago or age)

Fill 8’s for Don’t know

  1. Have you ever donated blood?

( )0 No (Skip to B.7)

( )1 Yes

( )8 Don’t know


  1. How many times have you donated your blood?

( )1 One time

( )2 2-4 times

( )3 5 times or more

( )8 Don’t know


  1. When was the last time you donated your blood?

Year ___ ___ ___ ___

(calculate if he/she said how many years ago or age)

Fill 8’s for Don’t know


  1. Did any doctor ever tell you that you have diabetes (too high or too low sugar level)?

( )0 No (Skip to B.9)

( )1 Yes

( )8 Don’t know


  1. Do you need any insulin for diabetes?

( )0 No (Skip to B.9)

( )1 Yes

( )8 Don’t know


  1. What is your height?

___ feet ___ ___ inches



  1. What is your current weight?

___ ___ ____ pounds



11. Interviewer will ask: I would now like to measure your waist circumference.


Waist circumference (cm)


First Second Difference Tolerance Third

|__|__|__|.|__| |__|__|__|.|__| |__|__|__|.|__| 2.0 |__|__|__|.|__|



12. Interviewer will ask: I would now like to measure your hip circumference.


Hip circumference (cm)


First Second Difference Tolerance Third

|__|__|__|.|__| |__|__|__|.|__| |__|__|__|.|__| 2.0 |__|__|__|.|__|






MEDICAL HISTORY ( )1 Very good ( )2 Good ( )3 Fair ( )4 Poor








C. FAMILY HISTORY


Now, I would like to learn more about the members of your family. First, I need to get some background about the structure of your family?



  1. How many children have you had? Please include only those children that are related to you by blood.

___ ___

# of children


  1. Were you adopted?

( )0 No

( )1 Yes (Skip to Section D)


( )8 Don’t know


  1. Counting only the brothers and sisters related to you by blood, how many brothers and sisters have you had? Please include half brothers and sisters.


___ ___ ___ ___

# of brothers # of sisters



  1. Counting only the aunts and uncles related to you by blood, how many aunts and uncles have you had? Please include half brothers and sisters.


___ ___ ___ ___

# of uncles # of aunts




  1. Has anyone in your family that is related to you by blood, ever been told they have cancer, include children, parents, grandparents, brothers, sisters, great grandparents, cousins or immediate aunts and uncles? (Include description of maternal or paternal relative)

( )0 No (Skip to Section D)

( )1 Yes

( )8 Don’t know







6. Which relative?

First name

Where did the cancer start? DK=888

How old were they when they were diagnosed?

a.





( )1 <20

( )2 20-29

( )3 30-39

( )4 40-49

( )5 50-59

( )6 60-69

( )7 >70

( )8 Don’t Know


b.





( )1 <20

( )2 20-29

( )3 30-39

( )4 40-49

( )5 50-59

( )6 60-69

( )7 >70

( )8 Don’t Know


c.





( )1 <20

( )2 20-29

( )3 30-39

( )4 40-49

( )5 50-59

( )6 60-69

( )7 >70

( )8 Don’t Know


d.





( )1 <20

( )2 20-29

( )3 30-39

( )4 40-49

( )5 50-59

( )6 60-69

( )7 >70

( )8 Don’t Know


e.





( )1 <20

( )2 20-29

( )3 30-39

( )4 40-49

( )5 50-59

( )6 60-69

( )7 >70

( )8 Don’t Know


f .





( )1 <20

( )2 20-29

( )3 30-39

( )4 40-49

( )5 50-59

( )6 60-69

( )7 >70

( )8 Don’t Know


g.





( )1 <20

( )2 20-29

( )3 30-39

( )4 40-49

( )5 50-59

( )6 60-69

( )7 >70

( )8 Don’t Know


h.





( )1 <20

( )2 20-29

( )3 30-39

( )4 40-49

( )5 50-59

( )6 60-69

( )7 >70

( )8 Don’t Know




FAMILY HISTORY ( )1 Very good ( )2 Good ( )3 Fair ( )4 Poor






D. ALCOHOL HISTORY


Now, I would like to ask you some questions about any alcoholic beverages you may drink on a regular basis.


  1. In your entire life, have you ever consumed more than 12 alcoholic beverages per year, such as beer, wine, wine coolers or liquor?

( )0 No (Skip to D.3)

( )1 Yes

( )8 Don’t know


  1. Tell me about the types of alcohol and when you were drinking them.

Period

1

2

3

4

5

6

7

a. At what age did you first start to drink/when you next began to drink?

__ __

__ __

__ __

__ __

__ __

__ __

__ __

b. How many cans, bottles

__ __

__ __

__ __

__ __

__ __

__ __

__ __

or 12 oz of beer did/do you

( )1 Per day

( )1 Per day

( )1 Per day

( )1 Per day

( )1 Per day

( )1 Per day

( )1 Per day

drink?

( )2 Per wk.

( )2 Per wk.

( )2 Per wk.

( )2 Per wk.

( )2 Per wk.

( )2 Per wk.

( )2 Per wk.


( )3 Per mo.

( )3 Per mo.

( )3 Per mo.

( )3 Per mo.

( )3 Per mo.

( )3 Per mo.

( )3 Per mo.


( )4 Per yr.

( )4 Per yr.

( )4 Per yr.

( )4 Per yr.

( )4 Per yr.

( )4 Per yr.

( )4 Per yr.

c. How many 4 oz glasses

__ __

__ __

__ __

__ __

__ __

__ __

__ __

of wine did/do you drink?

( )1 Per day

( )1 Per day

( )1 Per day

( )1 Per day

( )1 Per day

( )1 Per day

( )1 Per day


( )2 Per wk.

( )2 Per wk.

( )2 Per wk.

( )2 Per wk.

( )2 Per wk.

( )2 Per wk.

( )2 Per wk.


( )3 Per mo.

( )3 Per mo.

( )3 Per mo.

( )3 Per mo.

( )3 Per mo.

( )3 Per mo.

( )3 Per mo.


( )4 Per yr.

( )4 Per yr.

( )4 Per yr.

( )4 Per yr.

( )4 Per yr.

( )4 Per yr.

( )4 Per yr.

d. How many 1 ½ oz. shots

__ __

__ __

__ __

__ __

__ __

__ __

__ __

of liquor, by itself or in a

( )1 Per day

( )1 Per day

( )1 Per day

( )1 Per day

( )1 Per day

( )1 Per day

( )1 Per day

drink did/do you drink?

( )2 Per wk.

( )2 Per wk.

( )2 Per wk.

( )2 Per wk.

( )2 Per wk.

( )2 Per wk.

( )2 Per wk.


( )3 Per mo.

( )3 Per mo.

( )3 Per mo.

( )3 Per mo.

( )3 Per mo.

( )3 Per mo.

( )3 Per mo.


( )4 Per yr.

( )4 Per yr.

( )4 Per yr.

( )4 Per yr.

( )4 Per yr.

( )4 Per yr.

( )4 Per yr.











Period

1

2

3

4

5

6

7

e. Have you ever stopped

( )0 No (D3)

( )0 No (D3)

( )0 No (D3)

( )0 No (D3)

( )0 No (D3)

( )0 No (D3)

( )0 No (D3)

drinking or changed your

( )1 Stopped

( )1 Stopped

( )1 Stopped

( )1 Stopped

( )1 Stopped

( )1 Stopped

( )1 Stopped

patterns for more than 12

( )2 Changed

( )2 Changed

( )2 Changed

( )2 Changed

( )2 Changed

( )2 Changed

( )2 Changed

months?

pattern

pattern

pattern

pattern

pattern

pattern

pattern

f. What age did you stop








drinking or change your

__ __

__ __

__ __

__ __

__ __

__ __

__ __

patterns for more than 12








months?










  1. Have you had any alcoholic beverages such as beer, wine or liquor in the last 7 days?

( )0 No (Skip to Section E)

( )1 Yes

( )8 Don’t know


4.

In the last seven days, how much did you drink of the

Number:


following?:


a.

Cans, bottles or 12 oz. glass of beer

__ __ __


b.

4 oz. glasses of wine

__ __ __

c.

1 ½ oz. shots of hard liquor or drinks containing a

shot of hard liquor

__ __ __



ALCOHOL HISTORY ( )1 Very good ( )2 Good ( )3 Fair ( )4 Poor






E. TOBACCO HISTORY

Next, I would like to ask you some questions about any smoking history you may have.


  1. Have you ever smoked more than 100 cigarettes, which is equivalent to five packs, in your life?

( )0 No (Skip to Section F)

( )1 Yes

( )8 Don’t know


  1. Please tell me about your smoking history. I will be asking you about any times you may have stopped or changed your patterns.


Period

1

2

3

4

5

6

a.

In what year did you start smoking cigarettes or change your patterns?

__ __ __ __

__ __ __ __

__ __ __ __

__ __ __ __

__ __ __ __

__ __ __ __

b.

What was the average

__ __ __ __

__ __ __ __

__ __ __ __

__ __ __ __

__ __ __ __

__ __ __ __


number of cigarettes or packs per day you smoked during this time?

( )1cigarettes

( )2 packs

( )1cigarettes

( )2 packs

( )1cigarettes

( )2 packs

( )1cigarettes

( )2 packs

( )1cigarettes

( )2 packs

( )1cigarettes

( )2 packs

c.

After starting, did you change your patterns or stop smoking for more

than 6 months?

( )0 No (E3)

( )1 Stopped

smoking

( )2 Changed

pattern

( )0 No (E3)

( )1 Stopped

smoking

( )2 Changed

pattern

( )0 No (E3)

( )1 Stopped

smoking

( )2 Changed

pattern

( )0 No (E3)

( )1 Stopped

smoking

( )2 Changed

pattern

( )0 No (E3)

( )1 Stopped

smoking

( )2 Changed

pattern

( )0 No (E3)

( )1 Stopped

smoking

( )2 Changed

pattern



d.

In what year did you stop

smoking or change your

patterns for more than six months?

__ __ __ __

If this is a change of pattern, skip to

E2a

__ __ __ __

If this is a change of pattern, skip to

E2a

__ __ __ __

If this is a change of pattern, skip to

E2a

__ __ __ __

If this is a change of pattern, skip to

E2a

__ __ __ __

If this is a change of pattern, skip to

E2a

__ __ __ __

If this is a change of pattern, skip to

E2a

e.

Did you start smoking

( )0 No (E3)

( )0 No (E3)

( )0 No (E3)

( )0 No (E3)

( )0 No (E3)

( )0 No (E3)


again?

( )1Yes (E2a)

( )1Yes (E2a)

( )1Yes (E2a)

( )1Yes (E2a)

( )1Yes (E2a)

( )1Yes (E2a)

If R stopped smoking more than 6 months ago, Skip to Section F


  1. Have you increased or decreased your amount of cigarette smoking in the last 6 months?

( )0 No (Skip to E6)

( )1 Yes

( )8 Don’t know



Period

1

2

3

4.

How long ago did you change your level of smoking?


__ __

( )1 weeks

( )2 months


__ __

( )1 weeks

( )2 months


__ __

( )1 weeks

( )2 months

5a.

Since then, what is the average amount of cigarettes you smoked per day?


__ __

( )1 cigarettes

( )2 packs


__ __

( )1 cigarettes

( )2 packs


__ __

( )1 cigarettes

( )2 packs

5b.

Did you change your level of smoking again?

( )0 No (E6)

( )1 Yes (E4)

( )0 No (E6)

( )1 Yes (E4)

( )0 No (E6)

( )1 Yes (E4)


6. How many cigarettes have you smoked in the last 48 hours?

__ __ __



7. Have you ever smoked at least one cigar a month for more than 6 months?

( )0 No

( )1 Yes

( )8 Don’t know


8. Have you ever smoked a pipe on a daily basis for more than 6 months?

( )0 No

( )1 Yes

( )8 Don’t know



TOBACCO HISTORY ( )1 Very good ( )2 Good ( )3 Fair ( )4 Poor



















F. REPRODUCTIVE HISTORY (IF MALE SKIP TO SECTION G)

This next set of questions may seem personal, but remember that your answers are very important to us.


  1. Have you ever been pregnant?

( )0 No (Skip to question F.7)

( )1 Yes

( )8 Don’t know


  1. How many times have you been pregnant? __ __



1

2

3

4

5

6

7

8

9

10

11

12

3. How old were you when you became pregnant? (Should be chronological)














4. What was the outcome of this pregnancy? (Check one for each pregnancy)

01 Single live birth













02 Multiple live birth, any living













03 Multiple birth, none living













04 Stillbirth













05 Miscarriage













06 Induced Abortion













07 Ectopic or tubal













08 Currently pregnant













09 Other (specify) ______













If R had no live births, Skip to Section G


1

2

3

4

5

6

7

8

9

10

11

12

5. Did you breast feed any of these babies for at least two weeks or longer?

( )0 No (Skip to Section G)

( )1 Yes

( )8 Don’t know

6. For how many weeks did you breast feed these babies, until you stopped all together?















7. Have you had a menstrual period in the last 6 weeks? ( )0 No ( )1 Yes( )8 Don’t know


8. Are you still menstruating? ( )0 No ( )1 Yes (Skip to H) ( )8 Don’t know


9. At what age was your last menstrual period? ____ ____


10. What was the reason that your menstrual periods stopped?

( )1 Change of life or natural Menopause

( )2 Hysterectomy, still has ovaries

( )3 Hysterectomy, ovaries removed

( )4 Hysterectomy, don’t know whether ovaries removed

( )5 Currently pregnant

( )6 Other reason (specify why): _______________________________


11. Has a doctor or other health professional ever told you that you had completed menopause or the change in life? ( )0 No ( )1 Yes ( )8 Don’t know


12. Have you ever used hormonal medications just before, during or after menopause, such as pills, vaginal creams, shots, suppositories or skin patches?

( )0 No (Skip to Section H)

( )1 Yes

( )8 Don’t know




At what age did you start to use them?

Total number of years used? 77= still using

a. Estrogen pills (Premarin, Estrace, Estratab, Ogen)


( )0 No ( )1 Yes

__ __

__ __

b. Progresteron pills (Progestins, Provera, Megace)


( )0 No ( )1 Yes

__ __

__ __

c.Estrogen and progesterone pills (Prempo)


( )0 No ( )1 Yes

__ __

__ __

d. Estrogen and testerone (Estratest)


( )0 No ( )1 Yes

__ __

__ __


e. Estrogen vaginal cream

( )0 No ( )1 Yes

__ __

__ __


f. Estrogen shots

( )0 No ( )1 Yes

__ __

__ __


g. Estrogen skin patches (Estraderm)

( )0 No ( )1 Yes

__ __

__ __


h. Estrogen patch and progesterone pills

( )0 No ( )1 Yes

__ __

__ __


i. Suppository

( )0 No ( )1 Yes

__ __

__ __


j. Other _________________

( )0 No ( )1 Yes

__ __

__ __



REPRODUCTIVE HISTORY ( )1 Very good ( )2 Good ( )3 Fair ( )4 Poor















H. GENERAL HISTORY


  1. Are you having surgery in the near future?

( )0 No (Skip to ”Ask Liver Cases ONLY” or “Ask High

Risk Hospital Control ONLY” dependent on patient type)

( )1 Yes

( )8 Don’t know


  1. What kind of surgery are you having?


__________________________________ .



  1. When are you having this surgery?


__ __ / __ __ / __ __ __ __



ASK LIVER CANCER CASES ONLY (High Risk Cases, Skip to H.13)


  1. Are you currently receiving treatment?

( )0 No (Skip to H.7)

( )1 Yes

( )8 Don’t know


  1. What type(s) of treatment are you currently receiving?


a. TACE (chemotherapy through blood vessels)

( )0 No ( )1 Yes ( )8 DK

b. RFA (Tumor burning with radio waves)

( )0 No ( )1 Yes ( )8 DK

c. IFN (Interferon)

( )0 No ( )1 Yes ( )8 DK

d. Sorafenib (Nexavar)

( )0 No ( )1 Yes ( )8 DK

e. Other (please specify) ______________

  


( )0 No ( )1 Yes ( )8 DK













  1. How many treatment sessions have you received in your current treatment cycle and how long did you receive this/these treatment(s)?



Treatment Session

Treatment Name

First

Treatment

(Duration)

Second Treatment

(Duration)

Third

Treatment

(Duration)

Keep repeating until last treatment documented

(Duration)

TACE (chemotherapy through blood vessels)


( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __


( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __


( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __


( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __


RFA (Tumor burning with radio waves)



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __


IFN (Interferon)



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __


Sorafenib (Nexavar)



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __


Other


( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __





  1. Did you have any prior surgeries related to this cancer?

( )0 No (Skip to H.10)

( )1 Yes

( )8 Don’t know


  1. What kind of surgery did you have?


__________________________________ .



  1. When did you have this surgery?


__ __ / __ __ / __ __ __ __




  1. Have you had any treatment in the past (before this treatment or treatment cycle)?

( )0 No (Skip to H.17)

( )1 Yes

( )8 Don’t know


  1. What type of treatment did you receive?


a. TACE (chemotherapy through blood vessels)

( )0 No ( )1 Yes ( )8 DK

b. RFA (Tumor burning with radio waves)

( )0 No ( )1 Yes ( )8 DK

c. IFN (Interferon)

( )0 No ( )1 Yes ( )8 DK

d. Sorafenib (Nexavar)

( )0 No ( )1 Yes ( )8 DK

e. Other (please specify) ______________

  


( )0 No ( )1 Yes ( )8 DK



  1. How many treatment sessions did you receive in the past and how long did you receive this/these treatment(s)?



Treatment Session

Treatment Name

First

Treatment

(Year)

(Duration)

Second Treatment

(Year)

(Duration)

Third Treatment

(Year)

(Duration)

Keep repeating until last treatment documented

(Duration)

TACE (chemotherapy through blood vessels)


( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __


( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __


( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __


( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __


RFA (Tumor burning with radio waves)


( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __


( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __


( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __


( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __


IFN (Interferon)



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __


( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __


( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __


Sorafenib (Nexavar)



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __


Other


( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



)0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __


ASK HIGH RISK PATIENTS ONLY (Liver Cases Skip to question H.14)


  1. What type of chronic liver disease have you been diagnosed with?

a. Hepatitis C Virus Infection


( )0 No ( )1 Yes ( )8 DK

b. Hepatitis B Virus Infection

( )0 No ( )1 Yes ( )8 DK

c. Alcoholic Liver Disease

( )0 No ( )1 Yes ( )8 DK

d. Hemochromatosis (Iron Overload Disease)

( )0 No ( )1 Yes ( )8 DK

e. Primary Biliary Cirrhosis

( )0 No ( )1 Yes ( )8 DK

f. Wilson’s Disease (Copper Overload Disease)

( )0 No ( )1 Yes ( )8 DK

g. Autoimmune Hepatitis

( )0 No ( )1 Yes ( )8 DK

h. Nonalcoholic steatosis

( )0 No ( )1 Yes ( )8 DK

i. Other ___________________

( )0 No ( )1 Yes ( )8 DK


  1. Are you currently receiving treatment for chronic liver disease?

( )0 No (Skip to H.20)

( )1 Yes

( )8 Don’t know



  1. What type of treatment are you currently receiving?

a. IFN (Interferon)

( )0 No

( )1 Yes

( )8 Don’t Know

b. IFN(interferon)+ Ribavarin

( )0 No

( )1 Yes

( )8 Don’t Know

c. Lamivudin

( )0 No

( )1 Yes

( )8 Don’t Know


d. Adefovir

( )0 No

( )1 Yes

( )8 Don’t Know

e. Entecavir

( )0 No

( )1 Yes

( )8 Don’t Know


f. Telbivudine

( )0 No

( )1 Yes

( )8 Don’t Know

g. Phlebotomy (Blood letting)

( )0 No

( )1 Yes

( )8 Don’t Know

h. Chelation

( )0 No

( )1 Yes

( )8 Don’t Know

i. Ursodeoxycholic acid

( )0 No

( )1 Yes

( )8 Don’t Know

j. Mthotraxate

( )0 No

( )1 Yes

( )8 Don’t Know

k. Colchicine

( )0 No

( )1 Yes

( )8 Don’t Know

l. Penicillamine

( )0 No

( )1 Yes

( )8 Don’t Know

m. Trientine

( )0 No

( )1 Yes

( )8 Don’t Know

n. Oral zinc

( )0 No

( )1 Yes

( )8 Don’t Know

o. Amminium tetrathiomolybdate

( )0 No

( )1 Yes

( )8 Don’t Know

p. Prednisone

( )0 No

( )1 Yes

( )8 Don’t Know

q. Azathioprine

( )0 No

( )1 Yes

( )8 Don’t Know

r. Mercaptopurine

( )0 No

( )1 Yes

( )8 Don’t Know

s. Other

( )0 No

( )1 Yes

( )8 Don’t Know













16. How many treatment sessions have you received (of each treatment) in your current treatment cycle and how long did you receive this/these treatment(s)?



Treatment Session

Treatment Code (list treatment from question H.15 and write letter)

First

Treatment

(Duration)

Second Treatment

(Duration)

Third Treatment

(Duration)

Keep repeating until last treatment documented

(Duration)



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __




( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __




( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __





( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __




( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __




( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __




( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __




( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



)0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __




17. Have you had any treatment for chronic liver disease in the past?

( )0 No (Skip to H.20)

( )1 Yes

( )8 Don’t know















18. What type of treatment did you receive?

a. IFN(interferon)

( )0 No

( )1 Yes

( )8 Don’t Know

b. IFN(interferon)+ Ribavarin

( )0 No

( )1 Yes

( )8 Don’t Know

c. Lamivudin

( )0 No

( )1 Yes

( )8 Don’t Know

d. Adefovir

( )0 No

( )1 Yes

( )8 Don’t Know

e. Entecavir

( )0 No

( )1 Yes

( )8 Don’t Know

f. Telbivudine

( )0 No

( )1 Yes

( )8 Don’t Know

g. Phlebotomy (Blood letting)

( )0 No

( )1 Yes

( )8 Don’t Know

h. Chelation

( )0 No

( )1 Yes

( )8 Don’t Know


i. Ursodeoxycholic acid

( )0 No

( )1 Yes

( )8 Don’t Know

j. Mthotraxate

( )0 No

( )1 Yes

( )8 Don’t Know

k. Colchicine

( )0 No

( )1 Yes

( )8 Don’t Know

l. Penicillamine

( )0 No

( )1 Yes

( )8 Don’t Know

m. Trientine

( )0 No

( )1 Yes

( )8 Don’t Know

n. Oral zinc

( )0 No

( )1 Yes

( )8 Don’t Know

o. Amminium tetrathiomolybdate

( )0 No

( )1 Yes

( )8 Don’t Know

p. Prednisone

( )0 No

( )1 Yes

( )8 Don’t Know

q. Azathioprine

( )0 No

( )1 Yes

( )8 Don’t Know

r. Mercaptopurine

( )0 No

( )1 Yes

( )8 Don’t Know

s. Other

( )0 No

( )1 Yes

( )8 Don’t Know





19. How many treatment sessions did you receive (of each treatment) and how long did you receive this/these treatment(s)?



Treatment Session

Treatment Code (list treatment from question H.18 and write letter)

First

Treatment

(Duration)

Second Treatment

(Duration)

Third Treatment

(Duration)

Keep repeating until last treatment documented

(Duration)



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __


( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __


( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __




( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __




( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __





( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __




( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __





( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



)0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



( )0 Days __ __ __

( )1 Weeks __ __ __

( )2 Months __ __ __



________________________________________________________________________


ASK ALL PARTICIPANTS


20. May we contact you again later if we need to clarify any of the information you have provided? ( )0 No

( )1 Yes



18. Time ended: __ __ : __ __ ( )1 AM

( )2 PM




This completes our interview. I would like to now take the blood and urine sample. I want to thank you very much for the time you have spent in answering my questions today.



First get specimens and then provide reimbursement of $25.00.


Blood Specimen Collected


Urine Specimen Collected



H. ADMINISTRATIVE INFORMATION


  1. Date form completed: __ __ / __ __ / __ __ __ __


  1. Name of Interviewer: ___________________________________________________


  1. Interviewer ID number: __ __


  1. Interviewer’s Signature: _________________________________________________



I. INTERVIEWER REMARKS


  1. Interview was conducted:

( )1 Home

( )2 Hospital – inpatient (specify) _____________________

( )3 Hospital – outpatient (specify) ____________________

( )4 Non-residential, non-hospital location

(specify) __________________________

( )5 One of the Study Offices

( )6 Other (specify)_______________________


  1. Respondent’s cooperation was: ( )1 Very good

( )2 Good

( )3 Fair

( )4 Poor


  1. The overall quality of the interview was: ( )1 Very good

( )2 Good

( )3 Fair

( )4 Poor


  1. Did any of the following occur during the interview?


a. R did not know enough information regarding the topics

( )0 No ( )1 Yes

b. R did not want to be more specific

( )0 No ( )1 Yes

c. R did not understand or speak English well

( )0 No ( )1 Yes

d. R was upset or depressed

( )0 No ( )1 Yes

e. R had poor hearing or speech

( )0 No ( )1 Yes

f. R was confused by frequent interruptions

( )0 No ( )1 Yes

g. R was emotionally unstable

( )0 No ( )1 Yes

h. Others helped with the answers

( )0 No ( )1 Yes

i. Patient was reserved

( )0 No ( )1 Yes

k. R was physically ill

( )0 No ( )1 Yes

l. Other, specify ______________________________

( )0 No ( )1 Yes





  1. Comments/Remarks:

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________








8

Case/high risk questionnaire version 1.0

12-3-2009

File Typeapplication/msword
File TitleA research form about liver’s disease and cancers
AuthorChristina Frank
Last Modified ByVivian Horovitch-Kelley
File Modified2010-11-20
File Created2010-03-17

© 2024 OMB.report | Privacy Policy