Appendix A_TAMOXIFEN AND AROMATASE INHIBITOR Survey
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1 Article title: Patient-reported discontinuation of endocrine therapy and related side effects among women with early stage breast cancer Authors: Erin J. Aiello Bowles, Denise M. Boudreau, Jessica Chubak, Onchee Yu, Monica Fujii, Janet Chestnut, Diana S.M. Buist Corresponding author: Erin J. Aiello Bowles, MPH Group Health Research Institute 1730 Minor Ave, Suite 1600 Seattle, WA (ph), (fax)
2 A. Breast Cancer and Breast Cancer Treatment 1. Have you ever been diagnosed with breast cancer? (Thank you, please return the survey in the enclosed envelope) 2. How many times have you had breast cancer? Please count your first diagnosis, and any times that the cancer came back or recurred. 1 time 2 times 3 or more times Don t know how many times 3. Please mark the line below with an X at the point that shows your best guess about your chances of developing breast cancer again someday. Examples: 0% means you have no chance of having breast cancer again 50% means you may or may not have breast cancer again 100% means you think it is certain that you will have breast cancer again Did your health care provider ever recommended or prescribe tamoxifen or an aromatase inhibitor to treat your breast cancer? Tamoxifen may also be called: lvadex, Istubal, Valodex, Tamofen, Apo-tamox, vo-tamoxifen, PMS-tamoxifen, Gen-tamoxifen, Tamone, Soltamox (Brand names) Aromatase inhibitors include : anastrozole, letrozole, exemestane (generic names) and Arimidex, Femara, or Aromasin (brand names) (Go to question 5) (Go to Section H, Page 14) Don t know (Go to Section H, Page 14) 1
3 5. Which sources of information did you use when deciding to take these medication(s)? Please check or for each one. Source Doctors Other health care providers Family members Friends MyGroupHealth.com Other sources on the Internet TV, radio, magazines, newspapers Other 6. Check the box that best describes how you have used tamoxifen and/or aromatase inhibitors over your lifetime: I have taken only 1 aromatase inhibitor (Go to Section B on Page 3) I have switched between different aromatase inhibitors (Go to Section B on Page 3) I have taken both tamoxifen and aromatase inhibitors (Go to Question 6a below) I have taken only tamoxifen (Go to Section E on Page 8) I have never taken tamoxifen or aromatase inhibitors (Go to Section H on Page 14) I don t know (Go to Section H on Page 14) 6a. In what order did you take tamoxifen and aromatase inhibitor? I took tamoxifen then switched to an aromatase inhibitor(s) I took aromatase inhibitor(s) then switched to tamoxifen I switched back and forth between tamoxifen and aromatase inhibitor(s) more than once I don t know (Go to Section B on Page 3) 2
4 B. Aromatase Inhibitors Aromatase inhibitors include: anastrozole, letrozole, exemestane (generic names) and Arimidex, Femara, or Aromasin (brand names) 7. Think about all the times you have taken aromatase inhibitors up until today. Adding all those times together, how many total months or years have you taken aromatase inhibitors? Less than 6 months 6 to 11 months 12 to 23 months 2 years to less than 3 years 3 years to less than 4 years 4 years to less than 5 years 5 or more years Do not know 8. For how long did your health care provider recommend that you take aromatase inhibitors? Less than 6 months 6 to 11 months 12 to 23 months 2 years to less than 3 years 3 years to less than 4 years 4 years to less than 5 years 5 or more years Do not know 9. Did your health care provider talk to you or give you written information about why taking aromatase inhibitors is important? 10. Did your health care provider talk to you or give you written information about the possible side effects of aromatase inhibitors? 11. Please read the 3 statements below. Check the box that shows how strongly you agree or disagree with each one. We are interested in your opinion. There are no right or wrong answers. a. Using aromatase inhibitors reduces my chances of developing breast cancer again. Strongly agree Agree Neither agree nor disagree Disagree Strongly disagree 3
5 b. Using aromatase inhibitors reduces my chances of dying from breast cancer. Strongly agree Agree Neither agree nor disagree Disagree Strongly disagree c. Taking aromatase inhibitors reminds me of having breast cancer. Strongly agree Agree Neither agree nor disagree Disagree Strongly disagree 12. Below is a list of symptoms some people experience as side effects of aromatase inhibitors For each symptom, please check yes or no if you had it while taking aromatase inhibitors. Each time you check yes, check another box to the right to show whether or not you thought the symptom was a side effect of the aromatase inhibitors Side Effect, I did not have the symptom, I did have the symptom. (also check one of the columns to the right) Blood clot or thrombosis Feeling short of breath Stroke Headaches Cataracts or changes in your eyesight Feeling dizzy Aches or pain in your joints or muscles Osteoporosis or brittle bones Fracture or broken bone Incontinence (lack of bladder control) Retaining water Depression or changes in your mood Insomnia or other sleep problem Feeling tired Loss of appetite, upset stomach, or vomiting Weight gain Endometrial, ovarian, or uterine cancer I think the symptom was a side effect of the aromatase inhibitor I do not think the symptom was a side effect of the aromatase inhibitor 4
6 Side Effect, I did not have the symptom, I did have the symptom. (also check one of the columns to the right) Breast sensitivity or tenderness Hot flashes Vaginal bleeding, spotting, or discharge Vaginal dryness Sexual symptoms or loss of sex drive Hair thinning or loss If you had any side effects Go to question 13 If you checked no side effects Go to question 16 I think the symptom was a side effect of the aromatase inhibitor I do not think the symptom was a side effect of the aromatase inhibitor 13. Did you change how you used the aromatase inhibitor because of the side effect(s)? Go to question What changes did you make? I took less of the aromatase inhibitor I temporarily stopped taking the aromatase inhibitor I permanently stopped taking the aromatase inhibitor I switched to a different aromatase inhibitor (Arimidex, Femara, or Aromasin ) I switched to tamoxifen 15. Did you receive treatment for any side effects? I was hospitalized because of the side effect(s) The side effect(s) were treated with a medication Other treatment: treatment 16. Did your health care provider talk to you or give you written information about getting bone density tests while taking aromatase inhibitors? This is sometimes called BMD or bone mineral density. 5
7 17. Did you have a bone density test while you were taking aromatase inhibitors?, at a Group Health facility, at a non-group Health facility 18. Please check one box below and then move to the section listed at the right of your answer. I use aromatase inhibitors now (Go to Section C below) I have stopped taking aromatase inhibitors (Go to Section D on Page 7) C. For Women Using Aromatase Inhibitor w Aromatase include: anastrozole, letrozole, exemestane (generic names) and Arimidex, Femara, or Aromasin (brand names) 19. Many people have trouble taking medication as prescribed. Please answer each question below based on your experience taking aromatase inhibitor(s). We are interested in your experiences. There are no right or wrong answers. A. Do you ever forget to take your medicine? B. Are you careless at times about taking your medicine? C. When you feel your breast cancer is under control, do you sometimes stop taking your medicine? D. Sometimes if you feel worse when you take your medicine, do you stop taking it? 20. Please mark the line below with an X at the point that shows your best guess about how much of your aromatase inhibitor you have taken in the last month. For most people, this is less than 100% Examples: 0% means you have taken none 50% means you have taken half your aromatase inhibitor 100% means you have taken every single dose of your aromatase inhibitor 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 21. Have you ever used tamoxifen? YES (GO TO SECTION E ON PAGE 8) NO (GO TO SECTION H ON PAGE 14) 6
8 D. For Women Who Stopped Taking Aromatase Inhibitors Aromatase inhibitors include: anastrozole, letrozole, exemestane (generic names) and Arimidex, Femara, or Aromasin (brand names) 22. When did you stop taking aromatase inhibitors? Less than 1 month ago 1-6 months ago 7-12 months ago months ago More than 2 years ago 23. How did you decide to stop your aromatase inhibitor? I decided by myself to stop My health care provider decided I should stop My health care provider and I decided together that I should stop 24. What were the reasons you stopped taking your aromatase inhibitor? Please check yes or no for each reason. I completed the recommended course of therapy I did not like the side effects I did not think the aromatase inhibitor(s) were helping me I switched from an aromatase inhibitor to tamoxifen I had too many medications to take I developed a medical condition, and it was not safe for me to stay on aromatase inhibitors I began a treatment which made it unsafe for me to stay on the aromatase inhibitors (for example, chemotherapy or radiation) My medication(s) cost too much I was diagnosed with another case of breast cancer I was diagnosed with a different kind of cancer It decreased my quality of life 7
9 25. Do you plan to start taking aromatase inhibitors again? (Go to question 27) I am not sure (Go to question 27) 26. When do you plan to start taking aromatase inhibitors again? In the next 1 month In 1.1 to 3 months In 3.1 to 6 months In 6.1 to 12 months In 1.1 to 2 years In more than 2 years 27. Have you ever used tamoxifen? (GO TO SECTION E BELOW) (GO TO SECTION H ON PAGE 14) E. Tamoxifen Tamoxifen may also be called: lvadex, Istubal, Valodex, Tamofen, Apo-tamox, vo-tamoxifen, PMStamoxifen, Gen-tamoxifen, Tamone, Soltamox (Brand names) 28. Think about all the times you have taken tamoxifen up until today. Adding all those times together, how many total months or years have you taken tamoxifen? Less than 6 months 6 to 11 months 12 to 23 months 2 years to less than 3 years 3 years to less than 4 years 4 years to less than 5 years 5 or more years Do not know 29. For how long did your health care provider recommend that you take tamoxifen? Less than 6 months 6 to 11 months 12 to 23 months 2 years to less than 3 years 3 years to less than 4 years 4 years to less than 5 years 5 or more years Do not know 30. Did your health care provider talk to you or give you written information about why taking tamoxifen is important? 31. Did your health care provider talk to you or give you written information about the possible side effects of tamoxifen? 8
10 32. Please read the 3 statements below. Check the box that shows how strongly you agree or disagree with each one. We are interested in your opinion. There are no right or wrong answers. c. Using tamoxifen reduces my chances of developing breast cancer again. Strongly agree Agree Neither agree nor disagree Disagree Strongly disagree d. Using tamoxifen reduces my chances of dying from breast cancer. Strongly agree Agree Neither agree nor disagree Disagree Strongly disagree c. Taking tamoxifen reminds me of having breast cancer. Strongly agree Agree Neither agree nor disagree Disagree Strongly disagree 33. Below is a list of symptoms some people experience as side effects of tamoxifen For each symptom, please check yes or no if you had it while tamoxifen. Each time you check yes, check another box to the right to show whether or not you thought the symptom was a side effect of tamoxifen. Side Effect, I did not have the symptom, I did have the symptom. (also check one of the columns to the right) Blood clot or thrombosis Breast sensitivity or tenderness Cataracts or changes in your eyesight Depression or changes in your mood Feeling dizzy Endometrial, ovarian, or uterine cancer Feeling tired Retaining water Fracture or broken bone I think the symptom was a side effect of tamoxifen I do not think the symptom was a side effect of tamoxifen 9
11 Side Effect, I did not have the symptom, I did have the symptom. (also check one of the columns to the right) Aches or pain in your joints or muscles Hair thinning or loss Headaches Hot flashes Incontinence (lack of bladder control) Insomnia or other sleep problem Loss of appetite, upset stomach, or vomiting Osteoporosis or brittle bones Sexual symptoms or loss of sex drive Feeling short of breath Stroke Vaginal bleeding, spotting, or discharge Vaginal dryness Weight gain If you had any side effects Go to question 34 If you checked no side effects Go to question 37 I think the symptom was a side effect of tamoxifen I do not think the symptom was a side effect of tamoxifen 34. Did you change how you used tamoxifen because of the side effect(s)? Go to question What changes did you make? I took less of tamoxifen I temporarily stopped taking tamoxifen I permanently stopped taking tamoxifen I switched to an aromatase inhibitor (Arimidex, Femara, or Aromasin ) 36. Did you receive treatment for any side effects? I was hospitalized because of the side effect(s) The side effect(s) were treated with a medication 10
12 Other treatment: treatment 37. Did your health care provider talk to you or give you written information about getting bone density tests while taking tamoxifen? This is sometimes called BMD or bone mineral density. 38. Did you have a bone density test while you were taking tamoxifen?, at a Group Health facility, at a non-group Health facility 39. Please check one box below and then move to the section listed at the right of your answer. I use tamoxifen now (go to Section F on Page 12) I have stopped taking tamoxifen (go to Section G on Page 12) 11
13 F. For Women Using Tamoxifen w Tamoxifen may also be called: lvadex, Istubal, Valodex, Tamofen, Apo-tamox, votamoxifen, PMS-tamoxifen, Gen-tamoxifen, Tamone, Soltamox (Brand names) 40. Many people have trouble taking medication as prescribed. Please answer each question below based on your experience taking tamoxifen. We are interested in your experiences. There are no right or wrong answers. A. Do you ever forget to take your medicine? B. Are you careless at times about taking your medicine? C. When you feel your breast cancer is under control, do you sometimes stop taking your medicine? D. Sometimes if you feel worse when you take your medicine, do you stop taking it? 41. Please mark the line below with an X at the point that shows your best guess about how much of your tamoxifen you have taken in the last month. For most people, this is less than 100% Examples: 0% means you have taken none 50% means you have taken half your tamoxifen 100% means you have taken every single dose of your tamoxifen 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% GO TO SECTION H ON PAGE 14 G. For Women Who Stopped Taking Tamoxifen Tamoxifen may also be called: lvadex, Istubal, Valodex, Tamofen, Apo-tamox, votamoxifen, PMS-tamoxifen, Gen-tamoxifen, Tamone, Soltamox (Brand names) 42. When did you stop taking tamoxifen? Less than 1 month ago 1-6 months ago 7-12 months ago months ago More than 2 years ago 12
14 43. How did you decide to stop your tamoxifen? I decided by myself to stop My health care provider decided I should stop My health care provider and I decided together that I should stop 44. What were the reasons you stopped taking your tamoxifen? Please check yes or no for each reason. I completed the recommended course of tamoxifen therapy I did not like the side effects I did not think tamoxifen was helping me I switched from tamoxifen to an aromatase inhibitor I had too many medications to take I developed a medical condition, and it was not safe for me to stay on tamoxifen I began a treatment which made it unsafe for me to stay on tamoxifen (for example, chemotherapy or radiation) My medication(s) cost too much I was diagnosed with another case of breast cancer I was diagnosed with a different kind of cancer It decreased my quality of life 45. Do you plan to start taking tamoxifen again? (Go to Section H on Page 14) I am not sure (Go to Section H on Page 14) 46. When do you plan to start taking tamoxifen again? In the next 1 month In 1.1 to 3 months In 3.1 to 6 months In 6.1 to 12 months In 1.1 to 2 years In more than 2 years GO TO SECTION H ON PAGE 14 13
15 H. General Health 47. In general, would you say your health is. Excellent Very Good Good Fair Poor 48. Have you been told by a doctor or health care provider that you have osteoporosis or brittle bones? (Skip to question 51) I am not sure (Skip to question 51) 49. Were you first told this: Before your breast cancer was first diagnosed After your breast cancer was diagnosed 50. Were you told this: (check all that apply) During treatment with tamoxifen After treatment with tamoxifen During treatment with aromatase inhibitors After treatment with aromatase inhibitors N/A I was never treated with these medications 51. As of age 25, had you ever broken a bone that was not the result of a major/high impact accident or injury like an automobile accident? (Go to question 54) I am not sure (Go to question 54) 52. Did your first broken bone happen: Before your breast cancer was first diagnosed After your breast cancer was diagnosed 53. Did your first broken bone occur: (check all that apply) During treatment with tamoxifen After treatment with tamoxifen During treatment with aromatase inhibitors After treatment with aromatase inhibitors N/A I was never treated with these medications 14
16 54. Did your birth mother or father ever break, crush, or fracture a hip? Don t know 55. Did your health care provider talk to you or give you written information about ways to improve bone health (e.g., calcium, vitamin D, exercise)? 56. How often do you have a drink containing alcohol? Never (Go to 58) Monthly or less 2-4 times per month 2-3 times per week 4 or more times per week 57. How many drinks containing alcohol do you have on a typical day when you are drinking? Never drink 1 or 2 per day 3 or 4 per day 5 to 6 per day 7 to 9 per day 10 or more per day 58. Have you smoked at least 100 cigarettes (about 5 packs) in your entire life? One pack of cigarettes usually contains 20 cigarettes. (Go to Section I on page 16) Don t know 59. Do you now smoke cigarettes every day, some days, or not at all? Every day Some days t at all 60. Have you smoked a cigarette, even a puff, within the last 7 days? 15
17 I. Other Information 61. When you have a prescription, how often do you fill it at a Group Health pharmacy? Always Usually Rarely Never 62. How many miles do you live from the pharmacy where you fill most of your prescriptions? 1 mile or less 1.1 to 2 miles 2.1 to 5 miles miles Over 10 miles Mail order/online order 63. How would you describe the area where you live? Urban/City Suburban Rural/Country 64. On average, about how much do you spend per month (out of pocket) on all prescription medications that you take? $25 or less $26-$50 $51-$100 $101-$150 $151-$200 $201-$250 Over $ Considering all sources, what is your annual household income? $25,000 or less $25,001 $50,000 $50,001 $75,000 $75,001 $100,000 $100,001 - $150,000 Greater than $150,000 Prefer not to report We would like your permission to collect a limited amount of information from the group health automated records. We don t need to look at your entire medical record to get the information we need for this part of the study. We will use a computer to collect information on the medical care you use including doctor visits, lab tests, medications, and trips to the hospital. We will collect this information from the earliest of January 1, 2003 through June 30, Do we have your permission to collect this information? Please fill in today s date: / / MM / DD / YYYY 16
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