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Questionnaire

Volunteer ID
Women's Cancer Risk Questionnaire
FORECEE is a new clinical research programs, which aim to develop individualised
risk predictions and entire new prevention strategies for the four most common types of We would be very grateful if you could answer the following questions. If you are not
sure about exact details/dates, an approximate answer is better than none.
Your answers will be treated as strictly confidential and will only be used for medical
research. Thank you for agreeing to take part in our study.
Section 1: INTRODUCTION

1.1 Today's Date

1.2 Operator

1.2 Location


1.2 Volunteer ID
1.2 Volunteer ID


1.4 Month/Year of Birth

FORECEE -- Female cancer prediction using cervical omics to individualise screening and prevention
Version 3 (22 December 2015) Section 2: PERSONAL INFORMATION
2.1 What qualification do you have from school, college or the equivalent?

"O" level or equivalent "A" level or equivalent Clerical or commercial qualification (e.g secretarial) College/University degree
2.2 What is your marital status?

Single, never married Cohabiting Married Widowed Separated/divorced 2.3 What is your height?
cm or ft inches

2.4 What is your current weight?
a. What was your approximate weight in your twenties? b. If applicable, what was your approximate weight in your thirties? c. If applicable, what was your approximate weight in your forties? d. If applicable, what was your approximate weight in your fifties? e. If applicable, what was your approximate weight in your sixties? 2.5 What is your current skirt size (UK)?
2.6 Have you ever smoked cigarettes?
If ‘No', skip to 2.8
FORECEE -- Female cancer prediction using cervical omics to individualise screening and prevention
Version 3 (22 December 2015) 2.7 If ‘yes', please answer the following:
How many cigarettes per day do you smoke currently?

a. Approximately how many cigarettes did you smoke in your twenties? b. If applicable, approximately how many cigarettes per day did you smoke in your c. If applicable, approximately how many cigarettes per day did you smoke in your d. If applicable, approximately how many cigarettes per day did you smoke in your e. If applicable, approximately how many cigarettes per day did you smoke in your sixties?

2.8 How many units of alcohol (=one small glass wine, half a pint of beer, a
measure of spirits) do you drink per week

a. Approximately how many units of alcohol did you drink per week in your twenties? b. If applicable, approximately how many units of alcohol did you drink per week in c. If applicable, approximately how many units of alcohol did you drink per week in d. If applicable, approximately how many units of alcohol did you drink per week in e. If applicable, approximately how many units of alcohol did you drink per week in FORECEE -- Female cancer prediction using cervical omics to individualise screening and prevention
Version 3 (22 December 2015) 2.9 How many minutes per week do you engage in mild (gardening, walking
outside the house), moderate (fast walking, light gym class) or intense (ballgame,
running, prolonged swimming) physical activity?

a. Approximately, how many minutes per week did you engage in the following types of physical activity in your twenties? Mild activity Moderate activity Intense activity
b. If applicable, approximately how many minutes per week did you engage in the
following types of physical activity in your thirties? Mild activity Moderate activity Intense activity
c. If applicable, approximately how many minutes per week did you engage in the
following types of physical activity in your forties? Mild activity Moderate activity Intense activity
d. If applicable, approximately how many minutes per week did you engage in the
following types of physical activity in your fifties? Mild activity Moderate activity Intense activity
e. If applicable, approximately how many minutes per week did you engage in the
following types of physical activity in your sixties? Mild activity Moderate activity Intense activity

2.10 Which ethnic group do you belong to?

Pakistani
Bangladeshi
Black-Other
FORECEE -- Female cancer prediction using cervical omics to individualise screening and prevention
Version 3 (22 December 2015)
Section 3: FAMILY HISTORY OF CANCER
3.1 If you have no knowledge of your natural family, tick here and go to Section 4

3.2
With regard to your parents, brothers and sisters, please can you complete:
If alive If deceased, If the person has If the person has had
current age at

had cancer, the
cancer, age at diagnosis
type of cancer
Brother 1

3.3 Among children, grandparents and aunts or uncles, have any cancers been
diagnosed?
(Please specify relative affected) If anyone has had more than one cancer,
please enter the person again.
Relation
Indicate if mother or
Age cancer
father's side
diagnosed
e.g. Grandfather
List of cancers: Brain, Head & Neck, Throat, Lung, Stomach, Liver, Pancreas, Kidney,
Bowel, Bladder, Prostate, Bone, Blood, Melanoma, Non-Melanoma Skin Cancer, Other

3.4 Have you been seen /referred to a Cancer Genetics clinic?

FORECEE -- Female cancer prediction using cervical omics to individualise screening and prevention
Version 3 (22 December 2015) 3.5 Have you ever been diagnosed with any of the following genetic mutations?
BRCA1 BRCA2 Lynch Syndrome mutation (e.g, MLH1, MSH2, MSH6, PMS2, or EPCAM) Location of mutation:. Other gene mutation (e.g, PALPB2, RAD51C) Location of mutation:. Unknown
3.6 Do you know the specific position of the mutation based on the letter from your
geneticist?


3.7 Would you give your consent for the research team to contact your clinical
geneticist to provide us with details of any genetic mutations?


3.8 If known, please provide their contact details below.
FORECEE -- Female cancer prediction using cervical omics to individualise screening and prevention
Version 3 (22 December 2015) Section 4:
GYNAECOLOGICAL HISTORY
4.1 How old were you when you had your first period?

4.2 Have your periods ever temporarily stopped for more than three months – for
instance, because of a medical condition, an eating disorder, athletic training, gymnastics,
ballet or modelling (excluding pregnancy or breastfeeding)?
If ‘No', skip to Q4.10

4.3 For how long did you not have a period?

a. Approximately how many years did your periods temporarily stop in your twenties? b. If applicable, approximately how many years did your periods temporarily stop in c. If applicable, approximately how many years did your periods temporarily stop in d. If applicable, approximately how many years did your periods temporarily stop in e. If applicable, approximately how many years did your periods temporarily stop in your sixties?
4.4 Have your periods stopped completely? (That is, have you gone at least 6
months without having a period and you are not pregnant or on the contraceptive pill)
No Don't know as I started to take HRT before my periods had stopped If ‘No' or ‘Don't know', go to 4.8

4.5 If Yes, how old were you when your periods stopped completely?

FORECEE -- Female cancer prediction using cervical omics to individualise screening and prevention
Version 3 (22 December 2015) 4.6 What was the reason your periods stopped?
Natural menopause Surgery (e.g. hysterectomy/removal of ovaries) Chemotherapy, radiation or other treatment Mirena Coil Don't know Other (please specify)
4.7 Do you think or have you been told by a doctor that you have reached
menopause?

4.8 Please indicate below whether your periods are regular (you have a period
every month and can predict within 5 days when it will start) or irregular (unable to
predict
within 5 days when it will start and may skip 1-3 months), and please state the
average length of your cycle (e.g., 28 days)
a. Currently (if applicable)?
b. In your teens?
c. In your twenties?
d. In your thirties?
e. In your fourties?

4.9 If you are still having menstrual cycles, how long was it since the start of your
last menstrual period?


4.10 Have you ever taken Hormone Replacement Therapy (HRT)?
If ‘No', skip to Section 5

4.11 At what ages did you take HRT?

FORECEE -- Female cancer prediction using cervical omics to individualise screening and prevention
Version 3 (22 December 2015) 4.12 Please select the type of HRT you used and please estimate the number of
years/months you used the preparation?
Oestrogen-only HRT

(e.g, Bedroll, Climaval, Elleste Solo, Elleste Solo MX, Estraderm, Estradot, Evorel,
FemSeven, Hormonin, Oestrogel, Premarin, Progynova, Progynova TS, Sandrena,
Zumenon)
Cyclical/Sequential HRT
(may be either monthly or three-monthly; contains both oestrogen and progestogen; e.g,
Climagest, Clinorette, Cyclo-progynova, Elleste Duet, Evorel Sequi, Femoston,
FemSeven Sequi, Novofem, Prempak-C, Tridestra, Trisequens)
Continuous combined HRT Years
(e.g, Angeliq, Climes, Elleste Duet Conti, Evorel Conti, Femoston Conti, FemSeven
Conti, Indiana, Kliofem, Kliovance, Nuvelle Continuous, Premique Low Dose, Premise)
4.13 If you have been diagnosed with breast or cervical cancer, please indicate
whether your cancer was detected during routine screening (i.e. as a result of a
smear or mammogram).

Detected during routine screening FORECEE -- Female cancer prediction using cervical omics to individualise screening and prevention
Version 3 (22 December 2015) Section 5: GYNAECOLOGICAL AND SURGICAL HISTORY
5.1 Have you had the Human Papilloma Virus (HPV) Vaccine?


5.2 Have you ever had a cervical smear?


5.3 If so, when was your last smear?


5.4 Have you ever had an abnormal smear result?
(If No, go to 5.7)

5.5 If abnormal, what was the initial diagnosis?

Mild (CIN1) Moderate (CIN2) Severe (CIN3) Borderline or mild cell changes (low grade dyskaryosis) Moderate or severe cell changes (high grade dyskaryosis) Don't know Other 5.6 As a result of your smear, did you have any of the following procedures?

Repeat smear Biopsy of your cervix Loop Diathermy/LLETZ/LEEP Cryo-Cautery Cone Biopsy Hysterectomy Don't know Other FORECEE -- Female cancer prediction using cervical omics to individualise screening and prevention
Version 3 (22 December 2015) 5.7 Have you ever had an abnormal mammogram? (If no, go to 5.9)

5.8 Did you have any of the following procedures?

Breast ultrasound Breast biopsy Breast surgery
5.9 Have you been diagnosed with:
(Please tick)
Benign (non-cancerous) ovarian cyst Fibroids of the uterus (womb) Pelvic infection (PID) Polycystic ovaries Precancerous lesion of the cervix Microcalcifications of the breast Benign (non-cancerous) breast lump Any other non-cancerous ovarian or womb disease Any other disease of the breast/gynaecological organs
5.10 Have you ever had an operation on your ovaries, breast, cervix or uterus
(womb)?

If ‘No', skip to Section 6
FORECEE -- Female cancer prediction using cervical omics to individualise screening and prevention
Version 3 (22 December 2015) 5.11 If Yes, what surgical operations have you had? (Tick as many as apply)
Both ovaries removed Only one ovary removed Total removal of your womb and cervix (total hysterectomy) or only body of your uterus (womb) Removal of Fallopian tubes Removal of one Fallopian tube Curettage of the uterus (womb) Removal of (part of) the cervix (i.e., cone biopsy or loop excision) Breast biopsy Breast reduction Breast removal (mastectomy) Breast augmentation Tubal ligation (sterilisation) Other FORECEE -- Female cancer prediction using cervical omics to individualise screening and prevention
Version 3 (22 December 2015) Section 6: BIRTH CONTROL, PREGNANCY AND BREAST FEEDING
6.1 Have you ever used birth control pills either for contraception or for regulation
of a menstrual problem?

If 'No', skip to Q6.4

6.2 If yes, are you currently using birth control pills?

6.3 As best you can, estimate how many years you used birth control pills during
each of the following age categories
Progestin only
(mini pill, implants, injection)
a. Currently?
b. In your teens?
c. In your twenties?
d. In your thirties?
e. In your fourties?

Hormonal combined
(pill, injection, patch, vaginal ring)
a. Currently?
b. In your teens?
c. In your twenties?
d. In your thirties?
e. In your fourties?

Barrier or chemical
(condom, diaphragm, sponge, spermicide, cervical cap, etc.)
a. Currently?
b. In your teens?
c. In your twenties?
d. In your thirties?
e. In your fourties?
FORECEE -- Female cancer prediction using cervical omics to individualise screening and prevention
Version 3 (22 December 2015)
IUD non-medicated
(copper Intra-Uterine Device/IUD)
a. Currently?
b. In your teens?
c. In your twenties?
d. In your thirties?
e. In your fourties?

IUD medicated
(containing hormone)
a. Currently?
b. In your teens?
c. In your twenties?
d. In your thirties?
e. In your fourties?


6.4 If applicable, how many years in total have you used the following methods of
contraception?

If ‘None' skip to Q6.5
No. of years
Injection Patches Coil (intrauterine device) Rhythm Condom Diaphragm Sponge Spermicides Cervical cap Implant under your skin Withdrawal method Other FORECEE -- Female cancer prediction using cervical omics to individualise screening and prevention
Version 3 (22 December 2015)
6.6 Have you ever been pregnant?


If ‘No', skip to Section 7


6.7 If yes, please fill in the details for each time you have been pregnant

Order of pregnancy
Outcome of pregnancy
Single live born infant Twins, both live born Twins, one live born Twins, neither live born Triplets or higher order of birth Miscarriage/Termination Ectopic pregnancy Number of weeks of breast feeding FORECEE -- Female cancer prediction using cervical omics to individualise screening and prevention
Version 3 (22 December 2015) Section 7: FERTILITY PROBLEMS
7.1 Did you ever consult a physician about a fertility problem?

If ‘No', skip to Section 8
7.2 If yes, what was the fertility problem?
Never investigated No problem found I did not ovulate regularly I had a hormone imbalance Blocked tubes Endometriosis Partner had low sperm count or other problem Don't know
7.3 Have you ever had any treatment for a fertility problem?

If ‘No', skip to Section 8

7.4 If yes, please complete
Type of treatment

No of cycles
Fertility drugs alone Artificial insemination Surgery for blocked tubes FORECEE -- Female cancer prediction using cervical omics to individualise screening and prevention
Version 3 (22 December 2015) 7.5 If you have had fertility drugs or hormones to help you conceive, please
specify what type and for how long?

No of cycles
Name of drug
Clomid or clomiphene Pergonal Don't know the name of the drug Other (please specify) FORECEE -- Female cancer prediction using cervical omics to individualise screening and prevention
Version 3 (22 December 2015) Section 8: OTHER MEDICAL HISTORY
8.1 Have you ever been diagnosed with any of the following conditions?

Condition
Age diagnosed
Gallstones or gallbladder disease
Heart disease e.g. heart attack, angina
High blood pressure (not with pregnancy)
High cholesterol
Thyroid disease
Diabetes (not during a pregnancy)
Hip fracture
Stroke
Osteoarthritis
Osteoporosis
Rheumatoid arthritis
Ulcerative colitis/Crohn's Disease
Other autoimmune diseases (SLE,
sarcoidosis, scleroderma)
8.2 Have you ever been diagnosed with any type of cancer other than
breast/ovarian/cervical or womb/fallopian tube?

If ‘No', skip to Q8.4
FORECEE -- Female cancer prediction using cervical omics to individualise screening and prevention
Version 3 (22 December 2015) 8.3 If ‘Yes', please complete
Type of cancer
Age when Did you have
Did you have
Did you have
diagnosed
Brain Head & Neck Throat Lung Stomach Liver Pancreas Kidney Bowel Bladder Prostate Bone Blood Melanoma Non-Melanoma Skin Cancer Other cancer (please specify below) FORECEE -- Female cancer prediction using cervical omics to individualise screening and prevention
Version 3 (22 December 2015) 8.4 Have you ever used any medication containing the drugs mentioned below on a
regular basis
(meaning every day or almost every day for 6 months or longer)
Product
Total no of years
Using currently

Vaginal pessary
(e.g, for vaginal prolapse)

Hormones to stop periods
(Zoladex,
Buserelin, Suprecur, Synarel, Nafarelin)

Aspirin


Warfarin


Folic acid or folate


Anti-hypertensives
(ACE-i, Betablockers,
Calcium channel antagonists, Diuretics)

Statins
(or other medications to lower
cholesterol)

Tamoxifen
(Soltamox, Nolvadex-D,
Tamofen)

Raloxifine
(Evista)

Non-steroidal anti-inflammatories
(NSAIDs, Ibuprofen, Naproxen, Voltarol)

Anti-arthritis medication
(e.g, Orencia,
Humira, Kineret, Enbrel, Remicade, Rituxan,
Sampan, Cimzia, Actemra)

Anti-diabetic medications
(e.g, Metformin,
Insulin)

Medications to prevent heart failure

(Digoxin)

Asthma medications (inhaled steroids)

(Broncodilators)

Systemic immunosuppressants
(azathioprine, cyclosporine, daclizumab,
mycophenolate, prednisolone, sirolimus,
tacrolimus)
FORECEE -- Female cancer prediction using cervical omics to individualise screening and prevention
Version 3 (22 December 2015) Glucocorticoids (cortisone, prednisolone,
hydrocortisone)

Vitamin D


Progestin
(oral, depot preparations)

Aromatase inhibitors
(letrozole, anastrozole,
exemestane)

Thyroid medication
(thyroxine, carbimazole,
methimazole propylthiouracil)

Retinoids
(retinol, retinal,
tretinoin/retinoic acid,
etretinate/acitretin,
tazarotene, bexarotene,
adapalenel)

Glucocorticoids
(cortisone, prednisolone,
hydrocortisone)

Other medications
(specify which)

9.5 We would like if possible to contact you by email or telephone if we have any
queries. Would you be happy for us to contact you about your responses to this
questionnaire?

Thank you for completing the questionnaire
FORECEE -- Female cancer prediction using cervical omics to individualise screening and prevention
Version 3 (22 December 2015)

Source: http://forecee.info/Questionnaire.pdf

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Research Article Pharmacovigilance and drug safety in Calabria (Italy): 2012 adverse events analysis Chiara Giofrè, Francesca Scicchitano, Caterina Palleria, Carmela Mazzitello, Miriam Ciriaco, Luca Gallelli, Laura Paletta, Giuseppina Marrazzo, Christian Leporini, Pasquale Ventrice, Claudia Carbone, Patanè, Stefania Esposito, Felisa Cilurzo, Orietta Staltari, Emilio Russo, Giovambattista De Sarro, and the UNIVIGIL CZ GroupDepartment of Science of Health, School of Medicine, University of Catanzaro, Italy and Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Catanzaro, Italy