7 F154 Breast CA meds

Women's Health Initiative Observational Study (NHLBI)

F154 Breast CA meds

OS Participants

OMB: 0925-0414

⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0925-0414 can be found here:

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Ver. 1
OMB #0925-0414

Exp: XX/XXXX

Form 154 – Breast Health Supplement to the Medication Inventory
WHI Extension Study
-

Date Received:

- Affix label here-

(MM/DD/YY)

Participant ID: __ __

Reviewed By:

__ __ - ___ ___ ___ - __

First Name _______________________M.I._____

Last Name ________________________________

Contact Type:

1 Phone
2 Mail
8 Other

Visit Type:

3 Annual
4 Non-Routine

FCA
Language:

OUI

OU2

1 English 2 Spanish

OFFICE USE ONLY
Public reporting burden for this collection of information is estimated to average 5 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 (0925-0414). Do not
return the completed form to this address.

Instructions:
To help us learn about the health of WHI participants, we would like to know
more about some of the medications you may take.
As part of your participation in the Women’s Health Initiative, you previously
reported a diagnosis of breast cancer or breast cancer in situ. This form asks
about medications that you may have used to treat breast cancer.
If you would like to have a WHI staff member at the Clinical Coordinating
Center complete this form with you over the phone, please feel free to call
1-800-218-8415.

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WHI

Form 154 – Breast Health Supplement to the Medication Inventory
WHI Extension Study

Ver. 1

The first set of questions asks about medications known as SERMS (selective estrogen
receptor modulators). These medications include tamoxifen (Nolvadex®), raloxifene (Evista®),
and toremifene (Fareston®).
Since your breast cancer diagnosis:
1. Have you ever taken tamoxifen (Nolvadex®)?

0 No
1 Yes
9 Don’t know

1.1 How long did you take or have you taken tamoxifen?
(Use your best estimate; mark only one.)
1 Less than 1 month 4 1-2 years

2 1-5 months
3 6-11 months

5 3-4 years
6 5 or more years

2. Have you ever taken raloxifene (Evista®)?

0 No
1 Yes
9 Don’t know

2.1 How long did you take or have you taken raloxifene?
(Use your best estimate; mark only one.)
1 Less than 1 month 4 1-2 years

2 1-5 months
3 6-11 months

5 3-4 years
6 5 or more years

3. Have you ever taken toremifene (Fareston®)?

0 No
1 Yes
9 Don’t

know

3.1 How long did you take or have you taken toremifene?
(Use your best estimate; mark only one.)
1 Less than 1 month 4 1-2 years

2 1-5 months
3 6-11 months

Please go to next page
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5 3-4 years
6 5 or more years

WHI

Form 154 – Breast Health Supplement to the Medication Inventory
WHI Extension Study

Ver. 1

These next questions ask about medications known as anti-estrogen therapies or aromatase
inhibitors. These medications include anastrozole (Arimidex®), exemestane (Aromasin®), and
letrozole (Femara®).
Since your breast cancer diagnosis:
4. Have you ever taken anastrozole (Arimidex®)?

0 No
1 Yes
9 Don’t know

4.1 How long did you take or have you taken anastrozole?
(Use your best estimate; mark only one.)
1 Less than 1 month 4 1-2 years

2 1-5 months
3 6-11 months

5 3-4 years
6 5 or more years

5. Have you ever taken exemestane (Aromasin®)?

0 No
1 Yes
9 Don’t know

5.1 How long did you take or have you taken exemestane?
(Use your best estimate; mark only one.)
1 Less than 1 month 4 1-2 years

2 1-5 months
3 6-11 months

5 3-4 years
6 5 or more years

6. Have you ever taken letrozole (Femara®)?

0 No
1 Yes
9 Don’t know

6.1 How long did you take or have you taken letrozole?
(Use your best estimate; mark only one.)
1 Less than 1 month 4 1-2 years

2 1-5 months
3 6-11 months

Please go to next page
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5 3-4 years
6 5 or more years

WHI

Form 154 – Breast Health Supplement to the Medication Inventory
WHI Extension Study

Ver. 1

7. Have you ever taken any SERM or aromatase inhibitor that is not listed above, or that you
may not recall the name of?

0 No
1 Yes
9 Don’t know

7.1 How long did you take or have you taken this
medication? (Use your best estimate; mark only one.)
1 Less than 1 month 4 1-2 years

2 1-5 months
3 6-11 months

5 3-4 years
6 5 or more years

8. Have any of the following barriers prevented you from obtaining or taking the prescribed
breast cancer medications previously asked about (i.e., tamoxifen, raloxifene, toremifene,
anastrazole, exemestane, and letrozole)? (Please check all that apply.)

1 I did not experience any barriers to taking these medications.
2 I have never heard of these medications.
3 My health insurance would not cover these medications.
4 These medications or copayments cost too much.
5 It is a problem for me to get to my medical facility/physician.
6 Taking these medications would be inconvenient.
7 I was concerned about possible side effects or complications from these medications.
8 I was concerned about missing work due to taking these medications.
9 My family discouraged me from taking these medications.
10 My friends discouraged me from taking these medications.
11 I am taking too many medications.
12 I don’t like taking medications.
13 My physician did not recommend these medications for my particular type of breast disease.
14 Other:_________________________________________________
9. What is the date you finished answering this form?

Month

Day

Year

Thank you.
Please take a moment to review any questions you may have missed.
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WHI

Form 154 – Breast Health Supplement to the Medication Inventory
WHI Extension Study
Spanish translation underway

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Ver. 1

WHI Extension Study - Form 154 - Breast Cancer Prevention and Treatment Medications (Ver. 1)

Page 1

FORM:

154 – BREAST CANCER PREVENTION AND TREATMENT MEDICATIONS

Version:

1 – November, 2008

Description:

Self-administered or interviewer-administered; 3-page booklet; key-entered at the Clinical
Coordinating Center (CCC).

When used:

Collected one time as part of the annual contacts for Clinical Trial (CT) and Observational Study (OS)
participants enrolled in the WHI Extension Study who have indicated a previous breast biopsy or
diagnosis of breast cancer on WHI Form 33/33D.

Purpose:

To collect updated information on specific types of medications (SERMS and aromatase inhibitors)
currently being prescribed for the prevention and treatment of breast cancer.

GENERAL INSTRUCTIONS
1.

The form is printed in both English (Form 154) and Spanish (Form 154S) versions.

The Form 154 for WHI Extension Study participants will be labeled and mailed from the CCC directly to the
participant. Form is only mailed to participants with a previous breast biopsy or diagnosis of breast cancer.
•

The CCC mails the form to the participant and asks her to mail it back in a return envelope by a specified date.
Following the CCC mailing, if the participant does not return the Form 153 within 3 months of the first
mailing, it will be sent again. If the form is not returned within 2 months of the second mailing, the form will
be sent a third time. If the form is still not returned, CCC staff will contact the participants by telephone to
collect the information from willing participants. The CCC will data enter the forms.

In the event that this form is collected by FC staff, the form should be sent to the CCC for data entry.

I154V1.DOC 12/01/08

WHI Extension Study - Form 154 - Breast Cancer Prevention and Treatment Medications (Ver. 1)

Page 2

Item Instructions
1.

Tamoxifen (Nolvadex) –
Ever Taken

No/Yes/DK. Participants indicating “No” or “DK” skip to Q2.

1.1.

Tamoxifen – Duration