1. Department of Obstetrics & Gynaecology University of British Columbia Vancouver, BC, Canada Integrating quantitative and qualitative methods in the development of a p cancer survivors Integrating quantitative and qualitative methods in the development of a psychoeducational treatment for sexual dysfunction in female cancer survivors Lori A. Brotto, Ph.D. ©Brotto, 2005

2. Psychological treatments and female sexual dysfunction Heiman (2002) Arch Sex Beh Heiman (2002) Arch Sex Beh Efficacious psychological treatment for Female Orgasmic Disorder Efficacious psychological treatment for Female Orgasmic Disorder Some indication of efficacious psychological treatments for Hypoactive Sexual Desire Disorder and Dyspareunia Some indication of efficacious psychological treatments for Hypoactive Sexual Desire Disorder and Dyspareunia No available data testing efficacy of a psychological treatment for Sexual Arousal Disorder No available data testing efficacy of a psychological treatment for Sexual Arousal Disorder ©Brotto, 2005

3. Sexual arousal disorder Most of the evidence does not support efficacy of sildenafil or other vasoactive medications for FSAD Most of the evidence does not support efficacy of sildenafil or other vasoactive medications for FSAD Desire difficulties Orgasm difficulties Arousal difficulties Gynaecologic cancer survivors ©Brotto, 2005

4. BIOLOGICAL medication hysterectomy radiotherapy chemotherapy oophorectomy fatigue stress PSYCHOLOGICAL acute/chronic stress body image intimate relationship depression self-esteem sexual-esteem loss of reproduction SOCIOCULTURAL/ INTERPERSONAL culture religiosity social support roles relationships sexual function ©Brotto, 2005

5. Specific sexual concerns in gyn cancer survivors From 36-60% of women undergoing radical hysterectomy for cervical cancer acquire distressing sexual arousal difficulties Bergmark, 1999; 2002 Impaired genital response on vaginal photoplethysmography Maas et al., 2002 Represents one of the most distressing side effects of cancer treatment reported by women ©Brotto, 2005

6. Goals of this study To establish the components of a psychoeducational treatment targeted to sexual arousal complaints To establish the components of a psychoeducational treatment targeted to sexual arousal complaints To test the efficacy and feasibility of this treatment in gynecologic cancer survivors To test the efficacy and feasibility of this treatment in gynecologic cancer survivors To integrate quantitative with qualitative methods of assessment to determine efficacy To integrate quantitative with qualitative methods of assessment to determine efficacy Funded by a Sexuality Research Fellowship from the Social Science Research Council ©Brotto, 2005

7. Psychoeducational Intervention (PED) Psychoeducation Cognitive challenging Behavioural exercises Well-established treatment for female orgasmic disorder (Becoming Orgasmic, 1988) Progressive Relaxation Mindfulness training (Miracle of Mindfulness, 1976) Relationship and communication skills (Seven principles for making marriage work, 1999) ©Brotto, 2005

8. Participants Recruited from University of Washington Medical Center & Seattle Cancer Care Alliance Recruited from University of Washington Medical Center & Seattle Cancer Care Alliance 22 women with history of cervical or endometrial cancer, in remission 22 women with history of cervical or endometrial cancer, in remission Treated 1-5 years earlier by radical hysterectomy Treated 1-5 years earlier by radical hysterectomy Female Sexual Arousal Disorder (DSM-IV-TR) Female Sexual Arousal Disorder (DSM-IV-TR) Currently involved in a relationship Currently involved in a relationship Excluded: major depression, primary hypoactive sexual desire disorder Excluded: major depression, primary hypoactive sexual desire disorder ©Brotto, 2005

9. Procedures Session # 1 2 34 Orientation to lab Questionnaires Sexual Arousal Assessment Segment 1 PED Female Sexual Function Inventory (past 4 weeks) Segment 2 PED 1 month Female Sexual Function Inventory (past 4 weeks) Segment 3 PED 1 month Sexual Arousal Assessment Questionnaires Semi-structured Interview 1 month ©Brotto, 2005

10. Sexual Arousal Assessment Vaginal Pulse Amplitude (VPA) Vaginal Pulse Amplitude (VPA) Moment-to-moment changes in vaginal peripheral blood vessels Moment-to-moment changes in vaginal peripheral blood vessels Self-reported Arousal  perceived genital arousal  subjective sexual arousal  perceived autonomic arousal  positive and negative affect ©Brotto, 2005

11. Semi-structured interview Semi-structured in-depth interviews on the woman’s experience of her sexuality during cancer and during/after the PED Semi-structured in-depth interviews on the woman’s experience of her sexuality during cancer and during/after the PED Thematic analyses of transcripts Thematic analyses of transcripts Why include qualitative assessment? Why include qualitative assessment? ©Brotto, 2005

12. VariableMean SDScale maximum Age 49.4 (26-68)- FSFI Desire 2.40 0.886.0 FSFI Arousal 3.38 1.966.0 FSFI Lubrication 3.67 2.276.0 FSFI Orgasm 3.42 2.196.0 FSFI Satisfaction 3.83 1.666.0 FSFI Pain 3.76 2.316.0 DAS 100.0 22.7160.0 FSDS 21.82 11.8148.0 BDI 9.70 7.7863.0 Participant Characteristics 13 had early-stage cervical cancer 9 had early-stage endometrial cancer 17 also had bilateral salpingo-oophorectomy 7 also had external beam radiation therapy ©Brotto, 2005

13. Characteristics of women at pre-PED Depression Scores Lower overall FSFI r = -.429 More FSFI Pain r =.556 Poorer Relationship Adjustment r = -.462 Poorer Social Functioning r = -.817 Less Energy r = -.557 More sexual distress r =.585 Not associated with Ca type, BSO, radiation, or Not associated with Ca type, BSO, radiation, or time since surgery ©Brotto, 2005

14. Film Scale SubscaleNeutral stimulus Mean SD Erotic stimulus Mean SD VPA (x 10 -2 mV)* 5.24 2.91 7.85 5.41 Perception of genital arousal* 6.91 2.02 14.09 6.21 Subjective sexual arousal 7.82 1.10 9.82 2.04 Autonomic arousal* 8.90 3.88 13.38 4.07 Positive affect* 9.18 3.14 14.77 6.70 Negative affect 13.09 3.44 12.20 2.59 Anxiety* 2.45 1.18 1.55 0.60 Effects of erotic stimuli at pre-PED ©Brotto, 2005

15. Effects of PED on sexuality measures Pre-PED Post-PED DesireArousalLubricationOrgasmSatisfactionPain * ** FSFI *p <.01 * ©Brotto, 2005

16. Pre-PED Post-PED Effects of PED Relationship satisfaction (DAS) Emotional well-being (SF-36) p =.07 p <.01 Sexual Distress (FSDS) Depression (BDI) p <.001p <.01 ©Brotto, 2005

17. Effects of PED on VPA Pre-PEDPost-PED VPA % increase d = 0.39 20 40 60 80 ©Brotto, 2005

18. Interview feedback “ Whereas before I was thinking that I didn’t have any genital feelings…now I’m being able to focus on them and see that its not quite like it was before, like the tingling isn’t there, but there is feeling, and I just need to focus a little more.” “The part about reminding yourself that…yes you are still a woman. Yes, you do still have all of your woman parts and yes, they are still yours and they do still work.” “The mindfulness thing. I found that I can do it anytime…to be present in what you are doing.” “In general I feel more hopeful about my sexuality. And that’s what I wanted…but it looks like its going to take some work on my part and I wanted a simpler solution. “The mindfulness was one of the most important things…making myself really focus and be aware, and to focus a little bit more inward and to those areas that you feel badly about” ©Brotto, 2005

19. Qualitative themes Encouraged women to move beyond a sole cancer explanation for sexual difficulties Encouraged women to move beyond a sole cancer explanation for sexual difficulties Sexual response is not all-or-none Sexual response is not all-or-none Genital arousal response stronger after PED Genital arousal response stronger after PED Mindfulness most helpful component Mindfulness most helpful component ©Brotto, 2005

20. Conclusions Brief psychoeducational intervention shows promise for improving sexual response (subjective and physiological), relationship satisfaction, mood, and quality of life Brief psychoeducational intervention shows promise for improving sexual response (subjective and physiological), relationship satisfaction, mood, and quality of life Self-help format appealing to women Self-help format appealing to women Mindfulness training and exercises most beneficial Mindfulness training and exercises most beneficial ©Brotto, 2005

21. Unanswered questions Pilot project of PED in early-stage cervical & endometrial cancer survivors with sexual arousal problems What role do hormones play in the efficacy of the PED? Canadian Institutes of Health Research, Michael Smith Foundation for Health Research, UBC Faculty of Medicine, Department of Obstetrics & Gynaecology Is the PED efficacious and more cost-effective in a group format? What role do ethno- cultural variables play in the response to the PED? Is the PED effective in later-stage disease where palliative and end- of-life issues compound the concerns about sexual function? What are the mechanisms by which the PED works? Doesn’t work? Can the PED be efficacious in an entirely self-help format, perhaps with instructional DVD or telephone support, or is the “therapist” necessary? ©Brotto, 2005