Active tasks (eg, chores, exercise, swimming, lifting) activities) Choice of clothes (eg, color) Annoyance/anger. Psychological impact.

Transcription

1 How Do Breast Pain and Breakthrough Bleeding Associated With Hormonal Treatments for Menopausal Symptoms Impact Postmenopausal Women s Lives: Qualitative Interviews With Postmenopausal Women in the USA, China, Mexico, and Italy Abraham L, 1, * Arbuckle R, 2 Dennerstein L, 3 Humphrey L, 2 Maguire L, 2 Mirkin S, 4 Simon JA, 5 Symonds T, 1 Walmsley S 2 1 Pfizer Ltd, Tadworth, Surrey, United Kingdom; 2 Mapi Values Ltd, Bollington, Cheshire, United Kingdom; 3 University of Melbourne, Parkville, VIC, Australia; 4 Pfizer Inc, Collegeville, PA, USA; 5 George Washington University, Washington, DC, USA. *Presenting author. B A C K G R O U N D Estrogen plus progestin therapies (EPT) represent the current standard of care for postmenopausal women with a uterus for the treatment of symptoms associated with menopause While estrogens have shown success for treating climacteric symptoms, the presence of progestin is necessary to prevent endometrial proliferation Progestins contained in EPT are associated with side effects such as breast pain/tenderness and vaginal spotting/bleeding 1 and breast pain/tenderness are the most common reasons women permanently discontinue EPT and explain some of the observed decreases in overall quality of life scores when starting EPT 2 However, the particular aspects of postmenopausal women s health-related quality of life (HRQoL) that are ed by these side effects have not been explored indepth and require further research O B J E C T I V E S The objective of this study was to conduct qualitative interviews with postmenopausal women to better understand women s experience of breast pain and vaginal bleeding symptoms associated with EPT and to assess the of these symptoms on postmenopausal women s HRQoL M E T H O D S Study Sample 59 postmenopausal women taking EPT (aged years) were interviewed in the USA (n = 14), China (n = 15), Mexico (n = 15), and Italy (n = 15; Table 1) All had experienced breast pain and/or vaginal spotting/bleeding due to EPT in the previous 4 weeks, with 47 women experiencing both symptoms Table 1. Study Sample Characteristics USA (n = 14) China (n = 15) Mexico (n = 15) Italy (n = 15) Age of interviewee, y Mean Min, Max 41, 61 41, 58 47, 63 40, 54 Any children, n (%) Yes 11 (79) 15 (100) 13 (87) 11 (73) No 3 (21) 0 2 (13) 4 (27) Highest education level, n (%) High school diploma or GED 5 (36) 6 (40) 3 (20) 6 (40) Some years of college 4 (29) 0 2 (13) 0 Junior college degree 0 8 (53) 0 0 Certificate program (20) 1 (7) University/professional degree 5 (36) 1 (7) 6 (40) 7 (47) Secretarial skills education (7) 0 Junior high (7) Work status, n (%) Working full- or part-time 12 (86) 7 (47) 14 (93) 14 (93) Looking for work 1 (7) Full-time homemaker 1 (7) 0 1 (7) 1 (7) Retired 0 8 (53) 0 0 GED, general educational development. Study Design Interviews began with open-ended questions about the women s experience of taking EPT, and then moved to more focused discussion on the symptoms of breast pain/tenderness and vaginal spotting/bleeding due to EPT and any on HRQoL All interviews were audio recorded, transcribed verbatim, and translated to English where necessary Analysis Thematic analysis 3 of verbatim transcripts was conducted to identify concepts describing the experiences of the participants using ATLAS.ti software 4 R E S U LT S In all 4 countries, breast sensations experienced while taking EPT included pain and tenderness, breasts feeling swollen, and sensitivity to touch/contact. Vaginal spotting and bleeding were commonly described in terms of frequency, volume, color, and consistency Women described a variety of ways in which breast sensations and vaginal spotting/bleeding associated with EPT ed on their HRQoL. In particular, the domains of activities of daily living, psychological well-being, and sex life were ed (Figures 1 and 2) CONCEPT Active tasks (eg, driving, movement, exercise, housework, shopping) Sedentary tasks (eg, sleeping, watching TV, lying down) Choice of clothes/underwear Worry/anxiety/fear/concern Low self-esteem Sexual foreplay involving breasts, frequency of sexual activity, partner Figure 1. Conceptual framework of HRQoL s of breast sensations. CONCEPT Impact on Daily Life While some felt their symptoms of breast pain/tenderness and vaginal spotting/bleeding had no on their daily life, others detailed how their daily activities were affected by these symptoms The ability to carry out domestic activities involving lifting and bending was ed for some as these activities caused physical strain that induced bleeding, while one woman explained that she was unable to do domestic chores because bleeding left her feeling weak The ability to exercise was also ed, with some avoiding exercise when bleeding because of tiredness/fatigue or worry that the blood may leak causing embarrassment Enjoyment of social life was also ed for some: enjoying good times with your friends and your family, or you re out somewhere where you re probably watching a movie or something, and all of a sudden here comes oh, my God, here it comes, no, no, no Spotting and bleeding also ed choice of clothing and in particular the color of clothing selected: I liked to wear white pants a lot and since I take these kind of pills, and I started bleeding, well, I don t wear them Active tasks (eg, chores, exercise, swimming, lifting) Choice of clothes (eg, color) Worry/anxiety Depression Frequency of sexual activity, partner Figure 2. Conceptual framework of HRQoL s of vaginal spotting/bleeding. Breast sensations limited the ability to carry out active tasks (eg, driving, movement, exercise, housework, shopping) and also more sedentary tasks such as sleeping and watching TV. For example, in terms of driving, several women stated that the specific action of turning the steering wheel caused their breasts to move, which was a trigger for pain: Moving the steering wheel was just moving them. So I couldn t drive. Additionally, sedentary tasks such as sitting down to watch TV or lying down to sleep were affected either because relaxing brought greater awareness of breast pain: I was watching TV. And then I felt uncomfortable I couldn t keep watching TV or because some positions aggravated feelings of breast pain and tenderness. For instance, some women mentioned that they are not able to sleep on their sides or front, as the pressure on their breasts could trigger pain: And even lying on my side, if I m like that and putting pressure on, it will hurt Social life was ed for some women as they generally didn t feel like going out when in pain. One woman explained that her social life was affected because she preferred not to wear a bra when experiencing pain, yet did not feel she could leave the house without one: Well, I don t want to wear a bra, I don t want to so I would have to wear a bra to go outside. However, others described a refusal to allow the pain to their social activities, believing instead that it should be tolerated Some women with breast pain/sensitivity found that clothing could rub against breasts and nipples, triggering or exacerbating breast sensations. Bras in particular could feel tight and uncomfortable ing choice of bra worn: The bra bothers me a lot. I always want to loosen the bra, although I always choose the larger one Impact on Well-being s included feelings of anxiety/worry, annoyance, embarrassment, self-consciousness, anger, low self-esteem, and depression While some reported that they felt worried or anxious that they may have an accident in public, others were concerned it signaled something was wrong. Three women specifically mentioned that they were concerned spotting might be a sign of cancer:...do I have tumors or something? with several seeking reassurance from clinicians or by undergoing medical tests. One woman reported being so anxious about her bleeding that she experienced anxietyrelated rapid heart beats Some women reported feeling annoyed or angry because they felt too old to be bleeding or because of the hassle of having to use sanitary protection Conversely, a couple of women actually felt positive about their vaginal bleeding, saying it made them feel normal/youthful: Called the old friend in Shanghai dialect, menses give me a cheering message that I won t get old A range of feelings were evoked in the women, varying from annoyance and low self-esteem to worry and anger: It makes me feel so just very low selfesteem because I don t want to have to tell you that you can t touch me because I don t want my relationship to fall apart because I m having all these medical issues with my body Like vaginal bleeding, breast pain also caused concern that there might be something more serious wrong: What s wrong with me? Maybe I my two aunts died in one year of breast cancer, so I say maybe I have cancer. Again, several women had sought reassurance from their physicians to help alleviate their concerns: I had my breasts mammogram checked because of that because I thought I had some kind of tumor or something and no. Thank God I was normal Impact on Sex Life In terms of on sex life, several women spoke about avoiding intercourse when spotting/bleeding for several reasons, including feeling dirty, concern about making their spotting/bleeding worse, worry about the potential mess and embarrassment it might cause them, or because they weren t in the mood: Basically, I just don t really want to be intimate it s just extra messy and feeling a little bit bloated and not quite the best Bleeding had more on sexual activity than spotting, with 2 women stating that spotting does not stop them from having sex with their partners The sex lives and relationships of many of the women were directly influenced by their breast sensations and included problems engaging in sexual foreplay, reduced or no sexual activity, and concerns about the that this might have on their partners Six women stated that they were unable to engage in any sexual foreplay that involved their breasts: They want to touch you. They want to feel on you. They want to kiss it, suck it, whatever they want to do to it, and you can t let them do that because of the pain that you re in. Others suggested foreplay was still possible, but they had to be touched much more gently: I ask for the touch to be gentle; nothing aggressive or sudden Sexual activity was reduced or avoided by some women, either because the pain made intimacy difficult or because the pain affected desire for sex: I just think it affects your sex life it affects your sex life because you don t want to do it if you re in pain As with spotting and bleeding, several women were concerned about what their breast sensations had for their partners and their overall relationship: It affects the relationship with my husband because he lives it badly as if I am refusing him, so this is bad it affects the relationship with my husband, the intimacy C O N C L U S I O N S Utilizing an extensive interview process and a geographically and culturally diverse sample has revealed how breast pain and bleeding associated with taking EPT can several domains of HRQoL The of these side effects of EPT on postmenopausal women s HRQoL should be a consideration when reviewing treatment options for menopausal symptoms in the future References 1. Barnabei VM, et al. Obstet Gynecol. 2005;105(5 Pt 1): Welton AJ, et al. BMJ. 2008;337:a Ezzy D. Qualitative Analysis: Practice and Innovation. London, UK: Routledge; ATLAS.ti GmbH [computer program]. Version P O S T E R P R E S E N T E D A T T H E 2 2 N D A N N U A L M E E T I N G O F T H E N O R T H A M E R I C A N M E N O P A U S E S O C I E T Y ( N A M S ), S E P T E M B E R , , W A S H I N G T O N, D C.

2 B A C K G R O U N D Estrogen plus progestin therapies (EPT) represent the current standard of care for postmenopausal women with a uterus for the treatment of symptoms associated with menopause While estrogens have shown success for treating climacteric symptoms, the presence of progestin is necessary to prevent endometrial proliferation Progestins contained in EPT are associated with side effects such as breast pain/tenderness and vaginal spotting/bleeding 1 and breast pain/tenderness are the most common reasons women permanently discontinue EPT and explain some of the observed decreases in overall quality of life scores when starting EPT 2 However, the particular aspects of postmenopausal women s health-related quality of life (HRQoL) that are ed by these side effects have not been explored indepth and require further research O B J E C T I V E S The objective of this study was to conduct qualitative interviews with postmenopausal women to better understand women s experience of breast pain and vaginal bleeding symptoms associated with EPT and to assess the of these symptoms on postmenopausal women s HRQoL M E T H O D S Study Sample 59 postmenopausal women taking EPT (aged years) were interviewed in the USA (n = 14), China (n = 15), Mexico (n = 15), and Italy (n = 15; Table 1) All had experienced breast pain and/or vaginal spotting/bleeding due to EPT in the previous 4 weeks, with 47 women experiencing both symptoms Table 1. Study Sample Characteristics USA (n = 14) China (n = 15) Mexico (n = 15) Italy (n = 15) Age of interviewee, y Mean Min, Max 41, 61 41, 58 47, 63 40, 54 Any children, n (%) Yes 11 (79) 15 (100) 13 (87) 11 (73) No 3 (21) 0 2 (13) 4 (27) Highest education level, n (%) High school diploma or GED 5 (36) 6 (40) 3 (20) 6 (40) Some years of college 4 (29) 0 2 (13) 0 Junior college degree 0 8 (53) 0 0 Certificate program (20) 1 (7) University/professional degree 5 (36) 1 (7) 6 (40) 7 (47) Secretarial skills education (7) 0 Junior high (7) Work status, n (%) Working full- or part-time 12 (86) 7 (47) 14 (93) 14 (93) Looking for work 1 (7) Full-time homemaker 1 (7) 0 1 (7) 1 (7) Retired 0 8 (53) 0 0 GED, general educational development.

3 Study Design Interviews began with open-ended questions about the women s experience of taking EPT, and then moved to more focused discussion on the symptoms of breast pain/tenderness and vaginal spotting/bleeding due to EPT and any on HRQoL All interviews were audio recorded, transcribed verbatim, and translated to English where necessary Analysis Thematic analysis 3 of verbatim transcripts was conducted to identify concepts describing the experiences of the participants using ATLAS.ti software 4 R E S U LT S In all 4 countries, breast sensations experienced while taking EPT included pain and tenderness, breasts feeling swollen, and sensitivity to touch/contact. Vaginal spotting and bleeding were commonly described in terms of frequency, volume, color, and consistency Women described a variety of ways in which breast sensations and vaginal spotting/bleeding associated with EPT ed on their HRQoL. In particular, the domains of activities of daily living, psychological well-being, and sex life were ed (Figures 1 and 2) CONCEPT Active tasks (eg, driving, movement, exercise, housework, shopping) Sedentary tasks (eg, sleeping, watching TV, lying down) Choice of clothes/underwear Worry/anxiety/fear/concern Low self-esteem Sexual foreplay involving breasts, frequency of sexual activity, partner Figure 1. Conceptual framework of HRQoL s of breast sensations.

4 CONCEPT Active tasks (eg, chores, exercise, swimming, lifting) Choice of clothes (eg, color) Worry/anxiety Depression Frequency of sexual activity, partner Figure 2. Conceptual framework of HRQoL s of vaginal spotting/bleeding. Impact on Daily Life While some felt their symptoms of breast pain/tenderness and vaginal spotting/bleeding had no on their daily life, others detailed how their daily activities were affected by these symptoms The ability to carry out domestic activities involving lifting and bending was ed for some as these activities caused physical strain that induced bleeding, while one woman explained that she was unable to do domestic chores because bleeding left her feeling weak The ability to exercise was also ed, with some avoiding exercise when bleeding because of tiredness/fatigue or worry that the blood may leak causing embarrassment Enjoyment of social life was also ed for some: enjoying good times with your friends and your family, or you re out somewhere where you re probably watching a movie or something, and all of a sudden here comes oh, my God, here it comes, no, no, no Spotting and bleeding also ed choice of clothing and in particular the color of clothing selected: I liked to wear white pants a lot and since I take these kind of pills, and I started bleeding, well, I don t wear them Breast sensations limited the ability to carry out active tasks (eg, driving, movement, exercise, housework, shopping) and also more sedentary tasks such as sleeping and watching TV. For example, in terms of driving, several women stated that the specific action of turning the steering wheel caused their breasts to move, which was a trigger for pain: Moving the steering wheel was just moving them. So I couldn t drive. Additionally, sedentary tasks such as sitting down to watch TV or lying down to sleep were affected either because relaxing brought greater awareness of breast pain: I was watching TV. And then I felt

5 uncomfortable I couldn t keep watching TV or because some positions aggravated feelings of breast pain and tenderness. For instance, some women mentioned that they are not able to sleep on their sides or front, as the pressure on their breasts could trigger pain: And even lying on my side, if I m like that and putting pressure on, it will hurt Social life was ed for some women as they generally didn t feel like going out when in pain. One woman explained that her social life was affected because she preferred not to wear a bra when experiencing pain, yet did not feel she could leave the house without one: Well, I don t want to wear a bra, I don t want to so I would have to wear a bra to go outside. However, others described a refusal to allow the pain to their social activities, believing instead that it should be tolerated Some women with breast pain/sensitivity found that clothing could rub against breasts and nipples, triggering or exacerbating breast sensations. Bras in particular could feel tight and uncomfortable ing choice of bra worn: The bra bothers me a lot. I always want to loosen the bra, although I always choose the larger one Impact on Well-being s included feelings of anxiety/worry, annoyance, embarrassment, self-consciousness, anger, low self-esteem, and depression While some reported that they felt worried or anxious that they may have an accident in public, others were concerned it signaled something was wrong. Three women specifically mentioned that they were concerned spotting might be a sign of cancer:...do I have tumors or something? with several seeking reassurance from clinicians or by undergoing medical tests. One woman reported being so anxious about her bleeding that she experienced anxietyrelated rapid heart beats Some women reported feeling annoyed or angry because they felt too old to be bleeding or because of the hassle of having to use sanitary protection Conversely, a couple of women actually felt positive about their vaginal bleeding, saying it made them feel normal/youthful: Called the old friend in Shanghai dialect, menses give me a cheering message that I won t get old A range of feelings were evoked in the women, varying from annoyance and low self-esteem to worry and anger: It makes me feel so just very low selfesteem because I don t want to have to tell you that you can t touch me because I don t want my relationship to fall apart because I m having all these medical issues with my body Like vaginal bleeding, breast pain also caused concern that there might be something more serious wrong: What s wrong with me? Maybe I my two aunts died in one year of breast cancer, so I say maybe I have cancer. Again, several women had sought reassurance from their physicians to help alleviate their concerns: I had my breasts mammogram checked because of that because I thought I had some kind of tumor or something and no. Thank God I was normal

6 Impact on Sex Life In terms of on sex life, several women spoke about avoiding intercourse when spotting/bleeding for several reasons, including feeling dirty, concern about making their spotting/bleeding worse, worry about the potential mess and embarrassment it might cause them, or because they weren t in the mood: Basically, I just don t really want to be intimate it s just extra messy and feeling a little bit bloated and not quite the best Bleeding had more on sexual activity than spotting, with 2 women stating that spotting does not stop them from having sex with their partners The sex lives and relationships of many of the women were directly influenced by their breast sensations and included problems engaging in sexual foreplay, reduced or no sexual activity, and concerns about the that this might have on their partners Six women stated that they were unable to engage in any sexual foreplay that involved their breasts: They want to touch you. They want to feel on you. They want to kiss it, suck it, whatever they want to do to it, and you can t let them do that because of the pain that you re in. Others suggested foreplay was still possible, but they had to be touched much more gently: I ask for the touch to be gentle; nothing aggressive or sudden Sexual activity was reduced or avoided by some women, either because the pain made intimacy difficult or because the pain affected desire for sex: I just think it affects your sex life it affects your sex life because you don t want to do it if you re in pain As with spotting and bleeding, several women were concerned about what their breast sensations had for their partners and their overall relationship: It affects the relationship with my husband because he lives it badly as if I am refusing him, so this is bad it affects the relationship with my husband, the intimacy C O N C L U S I O N S Utilizing an extensive interview process and a geographically and culturally diverse sample has revealed how breast pain and bleeding associated with taking EPT can several domains of HRQoL The of these side effects of EPT on postmenopausal women s HRQoL should be a consideration when reviewing treatment options for menopausal symptoms in the future References 1. Barnabei VM, et al. Obstet Gynecol. 2005;105(5 Pt 1): Welton AJ, et al. BMJ. 2008;337:a Ezzy D. Qualitative Analysis: Practice and Innovation. London, UK: Routledge; ATLAS.ti GmbH [computer program]. Version