Mindfulness Based Cancer Recovery: Program summary and new results

Transcription

1 Tom Baker Cancer Centre Mindfulness Based Cancer Recovery: Program summary and new results Linda E. Carlson, Ph.D., R.Psych. Enbridge Research Chair in Alberta Heritage Foundation for Medical Research Health Scholar Professor, Department of Oncology University of Calgary, Faculty of Medicine Clinical Psychologist Department of Psychosocial Resources, Tom Baker Cancer Centre Research Clinical Care Education Psychosocial Oncology Helping You Live Well With Cancer

2 Outline Background Program Description Early Research Ongoing Research MINDSET results Future work

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4 What is mindfulness? Simple definition: Purposely paying attention to present moment experience with an open and accepting attitude Components of Intention, Attention and Attitude (Shapiro, Carlson, 2009) PNA present centered, nonjudgemental awareness (Labelle, 2012) Contrast this with typical past or future focussed thinking

5 Mindfulness I went to the woods because I wished to live deliberately, To front only the essential facts of life. And see if I could not learn What it had to teach, And not, when I came to die, Discover that I had not lived - Thoreau -

6 Mindful Attitudes Non judging Patience Acceptance Letting go Non striving Trust Beginners Mind

7 The Guest-House This being human is a guesthouse Every morning a new arrival. A joy, a depression, a meanness, Some momentary awareness comes As an unexpected visitor. Welcome and entertain them all! Even if they re a crowd of sorrows, Who violently sweep your house Empty of its furniture. Still, treat each guest honourably. They may be clearing you out For some new delight. The dark thought, the shame, the malice, Meet them at the door laughing, And invite them in. Be grateful for whoever comes, Because each has been sent As a guide from beyond. -Rumi -

8 Book: The Art and Science of Mindfulness Shapiro and Carlson 2009 Clinician training manual Includes chapters on theories of mindfulness, the mindful therapist, mindfulness influenced therapy and mindfulnessbased therapies

9 Mindfulness Based Stress Reduction (MBSR) Developed by Jon Kabat Zinn and colleagues at UMass Medical Centre in week secular training in mindfulness meditation combined with gentle Hatha yoga (2.5 hr classes, 45 min homework, 6hr Saturday retreat) First applied to chronic pain and anxiety patients Hundreds of scientific studies of its effects across many psychiatric and medical disorders Modifications include MBCT (depression), MBRP (addictions), MBSR for binge eating, etc

10 Tom Baker Cancer Centre Program Clinical program developed in 1996 by Michael Speca, Maureen Angen and Eileen Goodey Based on personal yoga/meditation practices Refined based on the UMass Model ~ 1998 Open to cancer patients and family members 2,000 participants Ongoing clinical program with research studies embedded

11 Mindfulness Based Cancer Recovery TBCC Research program began in 1998 Investigated a range of outcomes: Psychological distress, positive outcomes, symptoms, biomarkers As program was modified adopted the name Mindfulness Based Cancer Recovery MBCR

12 Book: Mindfulness Based Cancer Recovery Carlson & Speca Published Feb 2011 Patient centered Covers full MBCR curriculum with detailed exercises

13 Program Design 8 week intervention 1.5 hour weekly meetings with 2 instructors Discussion followed by mindful yoga and meditation (body scan, sitting, walking) Follow booklet which outlines the program/ includes a bibliography Daily meditation practice encouraged and monitored formal and informal (CD provided) Homework log of time spent in meditation 6 hour silent retreat between weeks 6 and 7

14 Weekly Themes 1. Introduction to Mindfulness 2. Mindfulness Attitudes 3. Mindbody Wisdom and Healing (stress responding vs. reacting) 4. Balance (breathing) 5. Mindful Coping 6. Cultivating Beneficial States of Heart and Mind (Imagery) 7. Deepening and Expanding 8. Moving into the World

15 Research Results

16 Overall summary Higher levels of overall mindfulness Improved quality of life Increases in spirituality Increases in post traumatic growth Better sleep Better cortisol rhythms Less inflammation Improved mood, vigor -Over 30 publications; see lindacarlson.ca Less rumination and depression Less worry, experiential avoidance Decreased stress Decreases in blood pressure

17 MASTER Study: Mindfulness based stress reduction and Acute Stress Test Experimental Reactivity in women with cancer Labelle, Campbell, Carlson, 2010 Nonrandomized waitlist trial of women diagnosed with cancer participating in MBSR Blood pressure monitored weekly throughout MBSR Tested pre post MBSR or waitperiod with laboratory stress protocol (TSST) not presented

18 Assessed for eligibility (N=291) Study Flowchart Eligible (N=125) Consented to participate (N=76) Testing Session 1 (Treatment group n=45; Control group n=31) Home BP (Weeks 1 and 8) MBSR (8 weeks) Waiting (8 weeks) Home BP (Weeks 1 and 8) 22.2% dropped out of program/study 9.7% dropped out of study Testing Session 2 n=37 Testing Session 2 n=28 Analyzed n=39 Excluded n=6 Analyzed n=31

19 Total Mood Disturbance POMS pre POMS post MBSR Waitlist

20 Depressive Symptoms 8 6 CES-D pre CES-D post MBSR Waitlist

21 Total Symptoms of Stress SOSI pre SOSI post MBSR Waitlist

22 Rumination RRQ pre RRQ post MBSR Waitlist

23 Resting Home Blood Pressure Campbell, Labelle, Bacon, Faris, Carlson, JOBM, 2011

24 Ongoing Studies

25 I CAN SLEEP: A non inferiority RCT of Mindfulness Based Stress Reduction (MBSR) and Cognitive Behavioral Therapy (CBT) for the treatment of Insomnia in CANcer survivors Garland, Campbell, Antel, Samuels, Carlson, in progress Randomly assigned to MBSR or CBT I. Treatments matched for time Assessment by actigraphy, sleep diary and questionnaire pre and post intervention and at 3 month follow up. MBSR will be deemed not inferior to CBT I if it produces at least 50% of the minimally important clinically significant change in insomnia severity Patients blind to study conditions **

26 Outcome Measures Primary Sleep Diary Actigraphy Pittsburgh Sleep Quality Index Dysfunctional Beliefs and Attitudes about Sleep Scale Insomnia Severity Index Secondary Calgary Symptoms of Stress Inventory Profile of Mood States Short Form Five Facet Mindfulness Questionnaire

27 Target Number of Patients Required for Screening (n=420) I-CAN SLEEP Flowchart Number of Patients Potentially Eligible (50% of those patients screened, n=210) Number of Patients that Consent to Participate (80% of those patients eligible, n=167) Number of patients that complete baseline assessment (95% of patients who consent, n=158) Randomization CBT-I program participation (n=79) MBSR program participation (n=79) Number of patients that complete post-program assessment (90% of patients who completed baseline, n=71) Number of patients that complete post-program assessment (90% of patients who completed baseline, n=71) Number of patients that complete 3 month follow up assessment (80% of those who complete post program assessment, n=63) Number of patients that complete 3 month follow up assessment (80% of those who complete Division post program of assessment, Psychosocial n=63) Oncology

28 15% Attrition 50% Attrition

29 Insomnia Severity Non-Inferiority Margin = 4 Diff Upper CI p Baseline Post program Follow Up F = 8.11, p <

30 Stress and Mood Disturbance F = 35.45, p <.001 F = 18.36, p <

31 ecalm: e Therapy for Cancer Applying Mindfulness Online MBSR Program for Underserved Cancer Patients in Alberta: A Randomized Waitlist Controlled Trial Zernicke, Campbell, Speca, McCabe, Flowers, Carlson, in progress Randomized waitlist controlled trial (N = 64) to evaluate an online synchronous MBSR program ethics approval Oct 2010 provided through emindful.com Primary outcome: Feasibility whether individuals with cancer are willing to participate and complete the online MBSR program Secondary outcomes: Questionnaires mood disturbance. symptoms of stress, mindfulness, spirituality and posttraumatic growth Powered to determine total mood disturbance and effect sizes for larger RCT

32 The ecalm Study Flowchart Recruitment Registry mail outs and other sources Eligibility Ax and Screening Distress thermometer/eligibility criteria Online MBSR Ax #2: Post- Intervention Online Consent Ax #1: Baseline Randomization Waitlist Ax #2: Post-Wait/Pre- Intervention Waitlist MBSR Ax #3: Waitlist Post- Intervention 8 weeks Measures Medical history & demographics Mood: POMS Stress: CSOSI Benefit finding: PTGI Spirituality: FACIT sp Mindfulness: FFMQ Meditation & homework logs Created measure for participant satisfaction Currently 47 enrolled and 10 signed up for next cohort Only two drop outs!

33 MINDSET Preliminary Results

34 MINDSET: Multi site randomized controlled trial comparing Mindfulness based Stress Reduction to Supportive Expressive Therapy on psychological and biological variables Carlson, Speca, Doll, Stephen, Faris, Magliocco, Beatty, in progress 300 distressed women post breast cancer treatment Randomized 2:2:1 to MBSR, SET or 1 day seminar Saliva, blood & questionnaires collected pre and post intervention and at 6 and 12 month follow up Measuring salivary cortisol, telomere length, telomerase and cytokines

35 Study Design

36 Research Questions 1) What are the comparative changes pre to post intervention among the three groups on the primary psychological outcome variables? 2) What are the comparative changes pre to post intervention on the biological outcome variable (cortisol profiles)? 3) What personality factors are related to improvements on primary outcomes for participants in each of the two interventions? 4) What are the relationships between the psychological and biological variables within each group? 5) What are the long term effects (6 months, 1 year) of the interventions on psychological and biological parameters compared to each other?

37 Baseline Measures Distress screening: Distress thermometer (DT) Demographics Disease Characteristics Health Behaviors Contamination (other therapies) Background (Moderators) Emotional Repression: Weinberger Adjustment Inventory (WAI) Emotional Suppression Courtauld Emotional Control Scale (CECS) Personality: NEO FFI

38 Psychological Outcome Measures Mood Profile of Mood States (POMS) Stress Calgary Symptoms of Stress Inventory (C SOSI) Quality of Life Functional Assessment of Cancer Treatment breast (FACT B) Spirituality Functional Assessment of Chronic Illness Therapy Spirituality (FACIT Sp) Social Support Medical outcomes survey social support scale (MOS SSS) Benefit finding Post traumatic growth inventory (PTGI)

39 Biological Outcome Measures Salivary cortisol Measured 4 times/day for three days Blood samples Frozen for later analyses Telomere length, telomerase and cytokines

40 33% Attrition

41 Preliminary Results Demographics N=249/272 Conditions SET (N=93) MBSR (N=106) Control (N=50) Age M (SD) (9.66) (9.52) (10.60) Months since diagnosis M (SD) (38.10) (25.08) (15.06) Marital status N (%) Single 15 (16.1%) 18 (17.0%) 6 (12.0%) Cohabiting/ Married 63 (67.7%) 64 (60.4%) 33 (66.0%) Divorced/ Widowed /Separated 15 (16.2%) 24 (22.8%) 11 (22.0%) Employment status N (%) Full-time 30 (32.3%) 43 (40.6%) 19 (38.0%) Part-time 23 (24.7%) 25 (23.6%) 8 (16.0%) Unemployed 10 (10.8%) 14 (13.2%) 7 (14.0%) Retired/ Disability 30 (32.2%) 24 (22.6%) 16 (32.0%) Highest education N (%) Primary/ Secondary/ High school/ GED 10 (10.8%) 13 (12.3%) 13 (24.0%) Some university/ College/ Technical 45 (48.4%) 49 (46.2%) 22 (44.0%) school University degree 29 (31.2%) 33 (31.1%) 13 (26.0%) Post-gradate/ Masters/ Doctoral degree 9 (9.6%) 11 (10.2%) 3 (6.3%) Stage of cancer N (%) Total N=227 Stage 0 1 (1.1%) 3 (3.3%) 2 (4.2%) Stage I 40 (46.0) 39 (42.4%) 21 (43.8%) Stage II 31 (35.6%) 40 (43.5%) 16 (33.3%) Stage III 13 (14.9%) 9 (9.8%) 9 (18.8%) Stage VI 2 (2.3%) 1 (1.1%) 0 (0%) 2 yrs 60% 3/4

42 Preliminary Data Analysis Objectives 1 and 2: group comparisons of psychological and some biological outcomes Baseline checks (one way ANOVA; χ 2 ): no group differences Linear Mixed Models ITT sample: Missing data estimated Per protocol completers analysis Planned contrasts: MBSR vs. Control; SET vs. Control; MBSR vs. SET

43 Primary outcomes: Intent to treat POMS Mood disturbance Mean score Baseline Post Intervention MBSR SET SMS Main effect of Time. Interaction: MBSR> SET and control, p<.05

44 Intent to treat C SOSI Stress symptoms 75 Mean score Baseline Post intervention MBSR SET SMS Main effect of time. Significant Interaction: MBSR>SET and control, p<.05

45 Per Protocol FACT B Quality of Life Mean score MBSR SET SMS 80 Baseline Post intervention Main effect of time. Interaction: MBSR>Control, p<.05

46 Diurnal cortisol rhythms: Normal vs. dysregulated Salivary cortisol ug/dl major depression normal PTSD chronic pain fibromyalgia 0 Slide courtesy of Dr. David Spiegel and Dr. Sandra Sephton

47 Cortisol and survival: Metastatic Breast Cancer From Sephton, Sapolsky, Kramer & Spiegel, JNCI. 92(12),

48 Cortisol: Change in average slope Cortisol slopes (log values) Mean MBSR SET SMS Baseline Post intervention Interaction: MBSR, SET > decrease in slope than control, p<.05

49 Cortisol group difference at each timepoint Bedtime cortisol (log) Cortisol concentrations Pre Post MBSR SET SMS

50 MINDSET Summary MBSR group showed more improvements in mood and stress from Pre to Post relative to both Control and SET groups MBSR group showed a significant improvement in quality of life from pre to post relative to the Control group Both MBSR and SET groups reported significantly improved diurnal cortisol rhythms and bedtime cortisol from Pre to Post relative to Control

51 MINDSET Further Directions Objectives 3 5: Assess larger group comparisons between MBSR and SET with inclusion of re randomized participants (ITT and completers) Assess moderator effects Assess long term effects Relationships among variables Biological outcomes (TL and telomerase, cytokines, gene array?)

52 Overall Conclusions MBCR as a program has developed over the years We ve shown its efficacy across a wide range of outcomes and patients Next steps? MBCR in relation to healing from surgery wounds Modifications for special situations/populations More online versions Other biomarkers Survival outcomes?

53 Acknowledgements Funders: Canadian Breast Cancer Research Alliance National Cancer Institute of Canada Canadian Cancer Society Alberta Heritage Foundation for Medical Research Canadian Institutes of Health Research Alberta Cancer Foundation Research Administration: Patti Wiebe Collaborators: Michael Speca* Kamala Patel Tavis Campbell Joanne Stephen Richard Doll Jackson Wu Peter Faris Tara Beattie Research Assistants: Dale Dirkse Linette Lawlor Barbara Pickering Jessica Kenney Josh Lounsberry Beth DeBruyn Andrea Berenbaum Fabiana Jakulj Students: Rie Tamagawa* Sheila Garland Laura Labelle Sarah Cook Laura Lansdell Katie Birnie Marion Hutchins Kristin Zernicke Mike Mackenzie MBSR Teachers: Shirley McMillan Eileen Goodey Maureen Angen Sarah Sample SET Therapists: Lisa Lamont Elaine Drysdale

54 Contact Information Calgary Mindfulness Based Stress Reduction Interest Group: Details on local group and links, purchase CDs Website: pdf files of publications Username: publications Password: Carlson Phone: E mail: l.carlson@ucalgary.ca