1. Results from a randomised controlled trial evaluating Mindfulness-Based Stress Reduction in Women with stages 0 to III Breast Cancer Caroline Hoffman, PhD Clinical and Research Director, The Haven London – Hereford - Leeds caroline.hoffman@thehaven.org.uk

2. Introduction The Haven –Breast Cancer Support Centres Registered Charity in London, Hereford, Leeds Study setting – Fulham, SW London

3. What does the Haven do? ‘No-one should have to face breast cancer alone’ Offering free support, information and complementary therapies before, during and after medical treatment. We have an outreach programme called The Haven at Home (2.5h DVD and 1h CD) for people who cannot reach a Haven

4. Hypothesis Tested There would be a difference in the intervention group compared to controls as a consequence of being exposed to MBSR in mood, disease-related quality-of-life, including endocrine symptoms, and wellbeing for women with stages 0 to 3 breast cancer, measured after 8- and 12-weeks.

5. Additional research questions 1)Is there a dose-related effect from attending more MBSR classes? 2) Is there a dose-related effect from doing MBSR home practice during the 8-week program?

6. Study numbers Power calculation based on POMS figures from Speca et al (2000) To achieve 80% power, aimed to recruit 240 participants, which allowing for dropouts, was to obtain 170 completed data sets. We needed 85 participants per arm Sample - women who had attended the Haven

7. Inclusion criteria Female Diagnosis of stages 0 – III breast cancer Age 18 – 80 years Ability to complete a questionnaire Aware of cancer diagnosis Between 2-24 months following completion of surgery, chemotherapy and/or radiotherapy Had participated in the Haven Programme

8. Exclusion Criteria Diagnosis of Stage 1V breast cancer Non-English speaking Substance misuse Suicidal thoughts Unable to give informed consent due to psychosis or apparent serious intellectual impairment

9. Recruitment method Eligible women were sent a letter of invitation Invited to attend a 1:1 recruitment interview Randomised into two groups 229 women recruited into the study, average of 9 months post hospital treatment 114 in intervention group, average age 49 115 in control group, average age 50 Controls given measurement tools at weeks 0, 8, 12 then offered MBSR programme afterwards MBSR offered between 2005-2006

10. Stages of breast cancer at diagnosis Intervention Group (N=114) Stage 0: 11 (9.6%) Stage 1: 34 (29.8%) Stage 2: 47 (41.2%) Stage 3: 22 (19.3%) Control Group (N=115) Stage 0: 6 (5.2%) Stage 1: 45 (39.1%) Stage 2: 47 (40.9%) Stage 3: 17 (14.8%)

11. Measurement Tools Profile of Mood States (POMS) (65 item) Primary outcome measure FACT-B (Breast) (37 item) plus FACT ES (Endocrine Symptoms) (19 item) (Quality of Life measures) WHO-5 Wellbeing scale (5 item) Completed at Weeks 0, 8 - 10, 12-14

12. MBSR programme 8-week MBSR programmes following UMass. programme Classes 1 and 8: 2 and a quarter hours Classes 2-6: 2 hours per week 6-hour day of mindfulness in week six on a Saturday: 10am to 4pm (both groups together for this)

13. Number and sizes of classes Class sizes: Up to 22 participants Pilot group 7 cycles of 8 week programmes (13 groups) Clinical supervision by phone

14. The Rose Room at the Haven in London

15. Reception at the Haven in London

16. Home Practice Home Practice Manual provided including photos of stretching exercises, meditation sitting positions, information on stress, some stories, exercises 4 x 45 minute CDs made for this research programme: Body Scan, Lying Stretches, Sitting Meditation, Standing Stretches Home practice sheets given out each week Record of formal home mindfulness practice kept and returned

17. Profile of Mood States (primary outcome measure) Total Mood Disturbance Subscales:Tension-Anxiety Depression-Dejection Anger-Hostility Vigour-Activity Fatigue-Inertia Confusion-Bewilderment T1 = weeks -2 to 0, T2 = weeks 8 to 10, T3 = weeks 12 to 14

18. Primary outcome : Means (SD)for POMS Total Mood Disturbance and subscales and estimates of treatment effects (95% CI) Outcome measure Experimen tal (N=103) mean (SD) Control (N=111) mean (SD) Mean difference (95% CI) between groups at T2 and T3 Model 1 – no covariates; T1 included as a repeated measure Model 2 – includes T1 as a covariate Model 3 – includes T1 and Depression- Dejection subscale as covariates Total score T1 Total Mood Disturbance43.65 (34.73)49.23 (39.37)ReferenceNA T2 Total Mood Disturbance30.02 (31.60)48.08 (39.89)-12.48 (-22.32,-2.65)-15.30 (-23.75, -6.86)-15.23 (-23.77, -6.68) T3 Total Mood Disturbance29.83 (34.19)45.47 (35.67)-10.7 (-19.67, -0.47)-12.91 (-21.02, -4.81)-13.51 (-21.69, -5.33) Interaction time*groupP=0.04P=0.558P=0.676 Group effect-P<0.001 Subscales T1 Tension-Anxiety13.16 (7.20)13.42 (7.24)ReferenceNA T2 Tension-Anxiety10.32 (7.0)13.36 (7.20)-2.78 (-4.85,-0.71)-2.93 (-4.67, -1.20)-2.77 (-4.53, -1.02) T3 Tension-Anxiety10.33 (7.02)12.73 (6.59)-2.14 (-4.18, -0.11)-2.30 (-3.96, -0.63)-2.27 (-3.96, -0.59) Interaction time*groupP=0.026 aP=0.493P=0.594 Group effect-P<0.001 aP=0.001 a T1 Depression-Dejection †† 12.79 (10.76)15.70 (12.79)ReferenceNA T2 Depression-Dejection10.0 (9.95)14.96 (13.23)-2.06 (-5.09, 0.97)-3.39 (-6.06, -0.71)NA T3 Depression-Dejection10.34 (10.32)14.10 (11.60)-0.85 (-3.85, 2.15)-2.32 (-4.86, 0.22)NA Interaction time*groupP=0.350 aP=0.365NA Group effect-P=0.017 aNA T1 Anger-Hostility10.75 (8.08)11.60 (8.62)ReferenceNA T2 Anger-Hostility8.78 (7.57)11.11 (8.88)-1.48 (-3.85, 0.89)-1.96 (-3.96, 0.05)-1.99 (-4.01, 0.03) T3 Anger-Hostility7.87 (6.72)11.04 (8.95)-2.31 (-4.33, -0.29)-2.69 (-4.44, -0.95)-2.82 (-4.58, -1.06) Interaction time*groupP=0.079 aP=0.458P=0.410 Group effect-P=0.005aP=0.004 a T1 Vigor-Activity-14.31 (6.53)-14.06 (6.19)ReferenceNA T2 Vigor-Activity-15.91 (6.0)-13.57 (6.61)-2.08 (-3.76, -0.41)-2.21 (-3.67, -0.75)-2.21(-3.69, -0.73) T3 Vigor-Activity-16.23 (6.63)-13.47 (6.22)-2.51 (-4.21, -0.80)-2.63 (-4.12, -1.15)-2.67 (-4.17, -1.16) Interaction time*groupP=0.01aP=0.606P=0.584 Group effect-P<0.001a T1 Fatigue-Inertia11.17 (6.64)11.75 (7.20)ReferenceNA T2 Fatigue-Inertia8.71 (6.10)11.62 (7.16)-2.33 (-4.31, -0.35)-2.68 (-4.31, -1.04)-2.63 (-4.28, -0.98) T3 Fatigue-Inertia9.27 (6.90)11.39 (6.73)-1.53 (-3.43, 0.37)-1.84 (-3.45, -0.22)-1.96 (-3.58, -0.33) Interaction time*groupP=0.068aP=0.324P=0.427 Group effect-P=0.002a T1 Confusion-Bewilderment10.11 (5.58)10.65 (5.57)ReferenceNA T2 Confusion-Bewilderment8.13 (4.71)10.33 (5.30)-1.65 (-2.96, -0.34)-1.91 (-3.01, -0.81)-1.93 (-3.04, -0.82) T3 Confusion-Bewilderment8.24 (5.32)9.63 (4.31)-0.84 (-2.15, 0.47)-1.09 (-2.20, 0.01)-1.20 (-2.31, -0.09) Interaction time*groupP=0.042aP=0.141P=0.189 Group effectP=0.002a

19. POMS Statistically Significant Results from MBSR compared to controls using Repeated Measures ANOVA Without adjusting for baseline scores Total mood disturbance, anxiety, vigour at T2 and T3 Confusion at T2 only After adjusting for baseline scores, there is more significance: Total Mood Disturbance, anxiety, vigour, fatigue, confusion at both T2 and T3 Depression at T2 only Anger at T3 only

20. FACT - Quality of Life measure FACT-B (breast) and FACT ES (endocrine symptoms) Physical wellbeing(PWB) Social and family wellbeing (SWB) Emotional wellbeing (EWB) Functional wellbeing (FWB) Breast-specific subscale (B) Endocrine-specific subscale (ES)

21. FACT-B and FACT-ES Results Statistically Significant Results from MBSR compared to controls using Repeated Measures ANOVA Without adjusting for baseline scores FACT-B, FACT-B TOI, FACT-ES, FACT-ES TOI, PWB and FWB at both T2 and T3 SWB at T2 only EWB at T3 only After adjusting for baseline scores FACT-B, FACT-B TOI, FACT-ES, FACT-ES TOI, PWB, EWB and FWB at T2 and T3 SWB at T2 only In addition EWB T3 scores were significantly greater than at T2

22. Clinical Significance for FACT from MBSR at T2 and T3 FACT-B FACT-B TOI

23. WHO-5 Wellbeing Questionnaire Statistically Significant Results from MBSR compared to controls using Repeated Measures ANOVA Without adjusting for baseline scores WHO-5 at both T2 and T3 After adjusting for baseline scores WHO-5 at both T2 and T3

24. Clinical Significance for WHO-5 WHO-5 mean (SD) % score Intervention (N=102)Control (N=110)Level of clinical significance in % (changes of ≥10% are significant) T1 WHO-552.2%50.1%1.1% T2 WHO-559.6%50.4%9.2% T3 WHO-560.3%50.6%9.7% T1= weeks -2 to 0, T2= weeks 8 to 10, T3 = weeks 12 to 14

25. Increased hours mindfulness home practice predicted improved scores At T2 for POMS anger (p=0.005) and WHO-5 (p=0.014) At T3 POMS subscales: vigor (p=0.029), confusion (p=0.001) FACT scales FACT-ES (p=0.006), FACT-ES TOI (p=0.003) WHO-5 item wellbeing scale (p=0.001).

27. Qualitative data feedback Do you believe you have experienced a greater degree of mindfulness as a result of participating in the stress reduction programme? Yes No Can you give some examples in your life where this has occurred? Please write down the most positive effect that this eight-week programme and mindfulness practice has had in your life Please write down what you found the most challenging about the programme and the mindfulness practice

28. Qualitative Data from Intervention Group In the intervention group, all participants questioned said that they had become more mindful as a result of MBSR.

29. A summary of themes from the qualitative data Main themes(N = 92) (%) Being calmer, centred, at peace, connected and more confident 30 (32.6%) The value and challenges of mindfulness practice 28 (30.4%) Being more aware27 (29.3%) Coping with stress, anxiety and panic27 (29.3%) Accepting things as they are, being less judgemental of myself and others 18 (19.6%) Improved communication and personal relationships 16 (17.4%) Making time and creating space for myself15 (16.3%)

30. How mindfulness has helped mood state ‘ it has given me a number of tools to deal with stress and tension and also helped me trust my inner voice more. As a result I am much more “with me” and feel a bit more confident’

31. How mindfulness helped with pain and symptoms ‘I at first wondered if the program was for me. After the first session, I was in tears, but Caroline convinced me to continue with the body scan and I did. It has helped greatly with my pain (peripheral neuropathy for 18 mo). The other practices have helped with my daily stress and remaining calm.’

32. How mindfulness helped with perception and life ‘The most positive effect has been the ability to stand back and view situations / thoughts / events in their true context and being more generally aware, my life has a greater quality, is more enhanced’

33. Final comments ‘Great to be supported through a difficult time and this has truly been a gift that I will always have and I think not only support me, but my family and friends because I will be in a better place’

34. Questions?