1. Susan M Cohen, DSN, FAAN 1 Susan Sereika, PhD 1, Margaret Stubbs, PhD 2, Kathleen Spadaro, PhD 2 Catherine Bender, PhD, FAAN 1 Carol Greco, PhD 1 1 University of Pittsburgh, 2 Chatham College Funded by NIH R21 CA106336 Society for Menstrual Cycle Research June 2011

3. Introduction Whether as a consequence of breast cancer treatment or naturally aging process the onset of menopause and its related symptoms (hot flashes) can contribute to the disruption of usual activities, alteration in sleep and decreased quality of life. Non hormonal self care approaches such as meditation hold promise for hot flash reduction. CANS 2012

4. Specific Aims Explore the treatment benefit of mindfulness meditation for menopausal symptom relief using changes in frequency and severity of hot flushes, frequency of sleep disruption, and various aspects of quality of life as outcome measures. CANS 2012

5. Procedure This study was a randomized clinical pilot study to explore the influence of mindfulness based stress reduction (MBSR) on menopausal symptoms. A two group design (group MBSR or group educational sessions) of 42 women was used. CANS 2012

6. Meditation Group Each session included: presentation & discussion of of mindfulness, meditation, relaxation, and the mind/body connection (20 min) experiential practice of meditation and gentle yoga (40-50 min) discussion of home practice of meditation, overcoming barriers to daily practice, and mindfulness in daily life (20 min). Written materials relevant to the topics and the specific meditation techniques were provided at each session. In addition, meditations were audio taped and given to participants in order to facilitate daily home practice. Participants were instructed to practice their meditation at least once each day for 30 minutes and record this practice on their symptom diary. Each group had 8 sessions. CANS 2012

7. Educational Group Educational sessions included topics related to menopausal symptoms and healthy life activities. Discussion of healthy living practices for midlife women A copy of Christiane Northrup’s the Wisdom of Menopause Each group had 8 sessions. CANS 2012

8. Results – Hot Flashes CANS 2012 Outcome Domain Summary Statistics Test statistic, p- value d between Baseline (Week 1) Mean (SE) Post-Intervention (Week 9) Mean (SE), d within Follow-up (Week 21) Mean (SE), d within Week 9 Week 21 Vasomotor Domain Weekly hot flash frequency - daily symptom diary Attention Control MBSR Weekly hot flash severity - daily symptom diary Attention Control MBSR Hot flash severity - Kupperman Index Attention Control MBSR Vasomotor score based - MENQOL Attention Control MBSR 54.45 (7.18) 58.40 (5.64) 1.82 (0.16) 2.06 (0.15) 2.26 (0.16) 2.40 (0.16) 6.55 (0.36) 6.46 (0.36) 43.20 (7.43), 0.56 38.67 (5.91), 0.54* 1.56 (0.17), 0.56 1.74 (0.16), 0.46 1.90 (0.19), 0.76* 2.05 (0.17), 0.50 5.27 (0.40), 0.70* 5.48 (0.39), 0.38 34.81 (7.98), 0.58 35.70 (6.11), 0.47 1.32 (0.18), 0.61* 1.56 (0.16), 0.70* 1.56 (0.22), 0.74* 1.94 (0.17), 0.59* 4.20 (0.47), 1.12* 4.75 (0.39), 0.83* F group =0.11, p=.7446 F time =1.80, p=.0181 F g×t =0.38, p=.9936 F group =1.57, p=.2169 F time =1.61, p=.0451 F g×t =0.87, p=.6235 F group =1.38, p=.2467 F time =7.66, p=.0011 F g×t =0.37, p=.6919 F group =0.27, p=.6065 F time =20.68, p<.0001 F g×t =0.49, p=.6124 -0.307 -0.004 0.051 0.354 -0.156 0.041 0.268 0.204

11. Results Hot flashes decreased significantly by time but not by group. The decrease was seen in both the 9 week intervention period and across the ful 21 weeks of the study. CANS 2012

12. Results - Sleep CANS 2012 Sleep Domain Weekly sleep disturbances frequency based on daily symptom diary Attention Control MBSR Weekly sleep disturbances severity based on daily symptom diary Attention Control MBSR Sleep disturbances severity based on the Kupperman Index Attention Control MBSR Difficulty sleeping from MENQOL (Item #14) Attention Control MBSR Global sleep quality based on the PSQIAttention Control MBSR 13.65 (2.42) 14.41 (2.29) 1.48 (0.21) 1.67 (0.20) 2.11 (0.21) 2.25 (0.20) 5.65 (0.58) 5.05 (0.57) 7.83 (0.78) 7.59 (0.77) 11.20 (2.51), 0.66* 9.51 (2.37), 0.64* 1.13 (0.22), 0.83* 1.24 (0.21), 0.36 1.65 (0.25), 0.28 1.79 (0.22), 0.66* 4.26 (0.64), 0.48 4.32 (0.62), 0.28 7.34 (0.82), 0.08 6.49 (0.79), 0.49 7.91 (2.64), 0.57 10.66 (2.42), 0.27 0.99 (0.23), 0.87* 1.12 (0.21), 0.51 1.41 (0.28), 0.47 1.33 (0.22), 1.07** 3.11 (0.74), 0.74* 3.54 (0.62), 0.65* 5.89 (0.95), 0,57 5.97 (0.79), 0.57* F group =0.11, p=.7389 F time =1.58, p=.0531 F g×t =0.96, p=.5123 F group =0.63, p=.4311 F time =1.64, p=.0400 F g×t =0.74, p=.7899 F group =0.08, p=.7798 F time =8.46, p=.0006 F g×t =0.20, p=.8177 F group =0.00, p=.9567 F time =8.34, p=.0006 F g×t =0.58, p=.5644 F group =0.15, p=.7042 F time =3.59, p=.0338 F g×t =0.26, p=.7746 -0.242 0.163 -0.081 0.243 -0.252 0.075 0.014 -0.664 0.118 -0.124

15. Results Sleep disruptions decreased over time Multiple components of sleep as measured by the PSQI improved over the 21 weeks of the study. PSQI measured Global Score (p=0.03); Sleep Latency (p=0.05) and Subjective Sleep Quality (p=0.01) all showed a positive time effect. CANS 2012

16. Conclusions In both the meditation and education groups, a positive time effect was seen in sleep disruption and sleep dimensions measured by the PSQI. There was a decrease in the mean number of daily hot flashes across 21 weeks in both groups (MBSR - 56.4 to 35.5) & (Ed -56.9 to 32.1). The number of home practice sessions may be the key to finding a significant result in future studies CANS 2012

17. In both the meditation and education groups, a positive time effect was seen in sleep disruption and sleep dimensions measured by the PSQI. There was a decrease in the mean number of daily hot flashes across 21 weeks in both groups (MBSR - 56.4 to 35.5) & (Ed -56.9 to 32.1). The number of home practice sessions may be the key to finding a significant result in future studies. Society for Menstrual Cycle Research June 2011

18. This T32 Supports interdisciplinary training of pre-doctoral and post doctoral trainees in cancer survivorship. Pre-doctoral candidates include both BSN to PhD and MSN to PhD students. Support for all trainees includes tuition support, a monthly stipend and research support. For more information contact: Dr Catherine Bender at cbe100@pitt.edu