Cancer Care – Tom Baker Cancer Centre
Mindfulness‐Based Cancer Recovery: Program summary and new results
Linda E. Carlson, Ph.D., R.Psych.
Enbridge Research Chair in Psychosocial Oncology
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
Clinical Care
Research
Education
Division of Psychosocial
Oncology
Helping You Live Well With Cancer
Outline
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Background
Program Description
Early Research
Ongoing Research
MINDSET results
Future work
Cancer Care Division of
Psychosocial Oncology
Helping You Live Well with Cancer
Cancer Care Division of
Psychosocial Oncology
Helping You Live Well with Cancer
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
Cancer Care Division of
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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 -
Cancer Care Division of
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Mindful Attitudes • Non‐judging
• Patience
• Acceptance
Cancer Care •
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Letting go
Non‐striving
Trust
Beginners Mind
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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 -
Cancer Care Division of
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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 mindfulness‐
based therapies
Cancer Care Division of
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Mindfulness‐Based Stress Reduction (MBSR)
• Developed by Jon Kabat‐Zinn and colleagues at UMass Medical Centre in 1979
• 8‐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…
Cancer Care Division of
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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
Cancer Care Division of
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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
Cancer Care Division of
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Book: Mindfulness‐Based Cancer Recovery
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Carlson & Speca
Published Feb 2011
Patient‐centered
Covers full MBCR curriculum with detailed exercises
Cancer Care Division of
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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
Cancer Care Division of
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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
Cancer Care Division of
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Helping You Live Well with Cancer
Research Results
Cancer Care Division of
Psychosocial Oncology
Helping You Live Well with Cancer
Overall summary…
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Higher levels of overall mindfulness Improved quality of life
Increases in spirituality
Increases in post‐traumatic growth
Better sleep
Better cortisol rhythms
• Less rumination and depression
Less inflammation
• Less worry, experiential Improved mood, vigor
avoidance
• Decreased stress
-Over 30 publications;
• Decreases in blood pressure
see lindacarlson.ca
Cancer Care Division of
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Helping You Live Well with Cancer
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 wait‐
period with laboratory stress protocol (TSST) – not presented
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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)
22.2% dropped
out of
program/study
Cancer Care Waiting
(8 weeks)
Home BP
(Weeks 1 and 8)
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
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Total Mood Disturbance
35
30
25
20
POMS pre
POMS post
15
10
5
0
MBSR
Cancer Care Waitlist
Division of
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Depressive Symptoms
14
12
10
8
CES-D pre
CES-D post
6
4
2
0
MBSR
Cancer Care Waitlist
Division of
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Total Symptoms of Stress
120
100
80
SOSI pre
SOSI post
60
40
20
0
MBSR
Cancer Care Waitlist
Division of
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Rumination
45
40
35
30
25
RRQ pre
RRQ post
20
15
10
5
0
MBSR
Cancer Care Waitlist
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Resting Home Blood Pressure
Campbell, Labelle, Bacon, Faris, Carlson, JOBM, 2011
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Ongoing Studies
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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 **
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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 Cancer Care Division of
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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 of
post program
assessment,
n=63)
Psychosocial Oncology
Helping You Live Well with Cancer
Cancer Care 15%
Attrition
50%
Attrition
Insomnia Severity
Non-Inferiority Margin = 4
Diff
Upper CI
p
Baseline
‐1.91
3.579
0.061
Post‐program
2.61
4.286
0.011
Follow‐Up
1.10
2.870
0.307
F = 8.11, p < .001
29
Cancer Care Division of
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Helping You Live Well with Cancer
Stress and Mood Disturbance
F = 35.45, p < .001
30
Cancer Care F = 18.36, p < .001
Division of
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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
Cancer Care Division of
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The eCALM Study Flowchart
Measures
‐ Medical history & demographics
‐ Mood: POMS
‐ Stress: CSOSI
‐ Benefit finding: PTGI
‐ Spirituality: FACIT‐sp
‐ Mindfulness: FFMQ
‐ Meditation & homework logs
‐ Created measure for participant satisfaction
Recruitment
Registry mail outs and other sources
Eligibility Ax and Screening
Distress thermometer/eligibility criteria
Online Consent
Ax #1: Baseline
Randomization
Online
MBSR
Waitlist
8 weeks
Ax #2: PostIntervention
Ax #2: Post-Wait/PreIntervention
Currently 47 enrolled and 10 signed up for next cohort
Waitlist MBSR
Ax #3: Waitlist PostIntervention
Cancer Care Only two drop‐outs!
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MINDSET Preliminary Results
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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
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Study Design
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?
Cancer Care Division of
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Baseline Measures
• Distress screening: – Distress thermometer (DT)
• Demographics
• Disease Characteristics
• Health Behaviors
• Contamination (other therapies)
Cancer Care • Background (Moderators)
– Emotional Repression:
• Weinberger Adjustment Inventory (WAI)
– Emotional Suppression
• Courtauld Emotional Control Scale (CECS)
– Personality: • NEO FFI
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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)
Cancer Care • 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)
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Biological Outcome Measures
• Salivary cortisol
– Measured 4 times/day for three days
• Blood samples
– Frozen for later analyses
– Telomere length, telomerase and cytokines
Cancer Care Division of
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33%
Attrition
Preliminary Results ‐ Demographics
N=249/272
Age M (SD)
Months since diagnosis M (SD)
Marital status N (%)
Single
Cohabiting/ Married
Divorced/ Widowed /Separated
Employment status N (%)
Full-time
Part-time
Unemployed
Retired/ Disability
Highest education N (%)
Primary/ Secondary/ High school/ GED
Some university/ College/ Technical
school
University degree
Post-gradate/ Masters/ Doctoral degree
Stage of cancer N (%) Total N=227
Stage 0
Stage I
Stage II
Stage III
Stage VI
SET (N=93)
53.78 (9.66)
28.32 (38.10)
Conditions
MBSR (N=106)
54.27 (9.52)
26.56 (25.08)
Control (N=50)
55.75 (10.60)
22.96 (15.06)
15 (16.1%)
63 (67.7%)
15 (16.2%)
18 (17.0%)
64 (60.4%)
24 (22.8%)
6 (12.0%)
33 (66.0%)
11 (22.0%)
30 (32.3%)
23 (24.7%)
10 (10.8%)
30 (32.2%)
43 (40.6%)
25 (23.6%)
14 (13.2%)
24 (22.6%)
19 (38.0%)
8 (16.0%)
7 (14.0%)
16 (32.0%)
10 (10.8%)
45 (48.4%)
13 (12.3%)
49 (46.2%)
13 (24.0%)
22 (44.0%)
29 (31.2%)
9 (9.6%)
33 (31.1%)
11 (10.2%)
13 (26.0%)
3 (6.3%)
1 (1.1%)
40 (46.0)
31 (35.6%)
13 (14.9%)
2 (2.3%)
3 (3.3%)
39 (42.4%)
40 (43.5%)
9 (9.8%)
1 (1.1%)
2 (4.2%)
21 (43.8%)
16 (33.3%)
9 (18.8%)
0 (0%)
2 yrs
60%
3/4
Preliminary Data Analysis
• Objectives 1 and 2: group comparisons of psychological and some biological outcomes
• Baseline checks (one‐way ANOVA; χ2): 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
Cancer Care Division of
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Primary outcomes: Intent‐to‐treat
POMS Mood disturbance
Mean score
45
40
35
30
MBSR 25
20
SET
SMS
15
10
5
0
Baseline
Post‐Intervention
Main effect of Time. Interaction: MBSR> SET and control, p<.05
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Intent‐to‐treat
C‐SOSI Stress symptoms
75
65
Mean score
55
MBSR 45
SET
35
SMS
25
15
5
‐5
Baseline
Post‐intervention
Main effect of time. Significant Interaction: MBSR>SET and control, p<.05
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Per‐Protocol
FACT‐B Quality of Life
110
Mean score
105
100
MBSR SET
95
SMS
90
85
80
Baseline
Post‐intervention
Main effect of time. Interaction: MBSR>Control, p<.05
Cancer Care Division of
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Diurnal cortisol rhythms: Normal vs. dysregulated
Salivary cortisol ug/dl
1.4
1.2
major depression
1.0
normal
.8
.6
PTSD
chronic pain
fibromyalgia
.4
.2
0
Slide courtesy of Dr. David Spiegel and Dr. Sandra Sephton
Cancer Care Division of
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Cortisol and survival: Metastatic Breast Cancer
From Sephton, Sapolsky, Kramer & Spiegel, 2000. JNCI. 92(12), 994-1000.
Cancer Care Division of
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Helping You Live Well with Cancer
Cortisol: Change in average slope
Cortisol slopes (log values)
0
‐0.01
Mean ‐0.02
MBSR ‐0.03
SET
‐0.04
SMS
‐0.05
‐0.06
‐0.07
Baseline
Post‐intervention
Interaction: MBSR, SET > decrease in slope than control, p<.05
Cancer Care Division of
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Cortisol group difference at each timepoint
Cortisol concentrations
Bedtime cortisol (log)
0.45
0.4
0.35
0.3
0.25
MBSR
SET
0.2
0.15
0.1
0.05
0
SMS
Pre
Cancer Care Post
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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
Cancer Care Division of
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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?)
Cancer Care Division of
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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?
Cancer Care Division of
Psychosocial Oncology
Helping You Live Well with Cancer
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
Cancer Care 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
Division of
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Helping You Live Well with Cancer
Contact Information
• Calgary Mindfulness‐Based Stress Reduction Interest Group: www.mindfulnesscalgary.ca
– Details on local group and links, purchase CDs
• Website: www.lindacarlson.ca
– pdf files of publications
Username: publications
Password: Carlson
• Phone: 403‐355‐3209
• E‐mail: l.carlson@ucalgary.ca
Cancer Care Division of
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Helping You Live Well with Cancer