Form 1 Lifestyle Questionnaire

Attachment 6: Questionnaire for Patients and Next-of-Kin OMB #: 0925-xxxx

Expiry Date: xx/xx/20xx

Public reporting burden for this collection of information is estimated to average 40 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.

Name of the Interviewer (Last Name, First Name)	________________________
DATE of Interview (DD/MM/YYYY)	|__||__|/|__||__|/|__||__||__||__|

Lifestyle Questionnaire for Cancer Patients or Next of Kin
A. Information on subject
A1. Identification number	|__| |__| |__||__||__||__|
A2. Sex	(1) Male |__| (2) Female |__|

Note: Please replace you with the patient’s name throughout interview for next of kin.

INTRODUCTION

Good morning/Good afternoon/Good evening.

My name is ....................... and first of all I would like to thank you for having accepted to participate in the previous interview and this follow-up study. We are conducting a follow-up study in .……. and in other countries of Central Europe in order to investigate the relationship between lifestyle and cancer prognosis. For this purpose, we will interview the patients, who participated in the parent study years ago. We really appreciate your participation again.

If you agree, I will ask you several questions and the answers will be recorded on this form.

I would like to reassure you that all that is said during the interview will be strictly confidential and that the information collected from several hundreds of people will only be used in scientific reports without any personal name or identifiers being mentioned.

Any likely benefits of the study for the well-being of the population rely on the accuracy of your answers. Therefore, if you do not understand the meaning of any of the questions, please don’t be afraid to ask.

At any time you may refuse to continue or to answer specific questions.

Before starting, I invite you to carefully read the enclosed acceptance form and to sign it. I will be happy to explain to you any detail regarding the study before you decide to sign the form. By signing the form, you accept to participate in this research: the acceptance as well as the refusal to participate, however, will have no consequence on the medical acts related to your current condition.

May we start now?

B. Cancer and Treatment Status for index primary cancer
B1. Please confirm your first cancer site
B2. Date or age at diagnosis	mm/yyyy |__||__|/|__||__||__||__| or age |__||__|
B3. Did you receive treatment for this cancer?	|__| Yes |__| No (Please skip to C1)
B4. Did you have surgery?	|__| Yes |__| No
B4a. If yes, when?	mm/yyyy |__||__|/|__||__||__||__| or age |__||__|
B5. Did you have radiotherapy?	|__| Yes |__| No
B5a. If yes, when?	mm/yyyy |__||__|/|__||__||__||__| or age |__||__|
B6. Did you have chemotherapy?	|__| Yes |__| No
B6a. If yes, when?	mm/yyyy |__||__|/|__||__||__||__| or age |__||__|
B7. When was all treatment completed?	mm/yyyy |__||__|/|__||__||__||__| or age |__||__|

C. Cancer and Treatment Status for tumour progression/recurrence (Recurrence implies first primary tumour had a complete response to treatment but came back and Metastasized. Progression means the tumour continued to grow and to spread.)
C1. Did you have any tumour progression/ recurrence?	|__| Yes |__| No (Please skip to D1)
C2. What was the site of progression/ recurrence? (text)
C3. Date or age at progression/recurrence	mm/yyyy |__||__|/|__||__||__||__| or age |__||__|
C4. Did you receive treatment for the progression/recurrence?	|__| Yes |__| No (Please skip to D1)
C5. Did you have surgery?	|__| Yes |__| No
C5a. If yes, when?	mm/yyyy |__||__|/|__||__||__||__| or age |__||__|
C6. Did you have radiotherapy?	|__| Yes |__| No
C6a. If yes, when?	mm/yyyy |__||__|/|__||__||__||__| or age |__||__|
C7. Did you have chemotherapy?	|__| Yes |__| No
C7a. If yes, when?	mm/yyyy |__||__|/|__||__||__||__| or age |__||__|

D. Cancer and Treatment information on Second Primary Cancer
D1. Did you develop a second primary tumour?	|__| Yes |__| No (Please skip to E1)
D2. Where was this second primary tumor? (text)
D3. When was the second tumor diagnosed?	mm/yyyy |__||__|/|__||__||__||__| or age |__||__|
D4. Did you receive treatment for the second primary?	|__| Yes |__| No (Please skip to E1)
D5. Did you have surgery?	|__| Yes |__| No
D5a. If yes, when?	mm/yyyy |__||__|/|__||__||__||__| or age |__||__|
D6. Did you have radiotherapy?	|__| Yes |__| No
D6a. If yes, when?	mm/yyyy |__||__|/|__||__||__||__| or age |__||__|
D7. Did you have chemotherapy?	|__| Yes |__| No
D7a. If yes, when?	mm/yyyy |__||__|/|__||__||__||__| or age |__||__|

E. Tobacco and Alcohol Habits: index primary cancer

Did you smoke cigarette, papirosi, cigar/cigarillos, or pipe…

Tobacco use	E1a. at the time of diagnosis of the first primary cancer?	E1b. during treatment of the first primary cancer?	E1c. after all treatment was completed?
(cigarette, papirosi, cigar/cigarillos)	|__| Yes |__| No	|__| Yes |__| No	|__| Yes |__| No
Alcohol use	E2a. Did you drink beer, wine, or liquor at diagnosis of the first primary cancer?	E2b. during treatment?	E2c. after all treatment was completed?
(beer, wine, liquor)	|__| Yes |__| No	|__| Yes |__| No	|__| Yes |__| No

F. Tobacco and Alcohol Habits: second primary cancer

Did you smoke cigarette, papirosi, cigar/cigarillos, or pipe…

Tobacco use (cigarette, papirosi, cigar/cigarillos, pipe)	F1a. at the time of diagnosis of the second primary cancer?	F1b. during treatment of the second primary cancer?	F1c. after all treatment was completed?
	|__| Yes |__| No	|__| Yes |__| No	|__| Yes |__| No
Alcohol use (beer, wine, liquor)	F2a. Did you drink beer, wine, or liquor at diagnosis of the second primary cancer?	F2b. during treatment?	F2c. after all treatment was completed?
	|__| Yes |__| No	|__| Yes |__| No	|__| Yes |__| No

G. For women only: The following section is only for women.

G. Information on reproductive history
G1. Have you ever had a menstrual period?	|__| Yes |__| No (Please skip to G2)
G1a. Age at first menstrual period	|__||__| years old |__| Don’t know
G2. Have you ever used birth control pills or other hormonal contraceptives	|__| Yes |__| No (Please skip to G4)
G3. In total, how many years had you taken birth control pills or hormones?	|__||__| Years |__| Don’t know
G4. How many children have you had?	|__||__| children |__| Don’t know
G5. How old were you when your first (live) child was born?	|__||__| years old |__| Don’t know
G6. Did you ever breastfeed a child for one month or more?	|__| Yes |__| No |__| Don’t know
G7. Have you had your menopause?	|__| Yes |__| No (Please skip to the remaining questions.) |__| Don’t know
G8. Age when menstrual period stopped	|__||__| years old |__| Don’t know
G9. Have you ever taken oestrogens, progesterone or other female hormones for menopause? (not including oral contraceptive (birth control) pills.)	|__| Yes |__| No |__| Don’t know
G10. In total for how many years did you take oestrogens, progesterone or other female hormones?	|__||__| Years |__| Don’t know

We have completed the interview. Thank you very much for your time and effort.

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