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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 [email protected] Introduction.

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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

[email protected]


Introduction
Introduction Mindfulness-Based Stress Reduction in Women with stages 0 to III Breast Cancer

  • The Haven –Breast Cancer Support Centres

  • Registered Charity in London, Hereford, Leeds

  • Study setting – Fulham, SW London


What does the haven do
What does the Haven do? Mindfulness-Based Stress Reduction in Women with stages 0 to III Breast Cancer

  • ‘No-one should have to face breast cancer alone’

  • Offering freesupport, 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


Hypothesis tested
Hypothesis Tested Mindfulness-Based Stress Reduction in Women with stages 0 to III Breast Cancer

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.


Additional research questions
Additional research questions Mindfulness-Based Stress Reduction in Women with stages 0 to III Breast Cancer

  • 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?


Study numbers
Study numbers Mindfulness-Based Stress Reduction in Women with stages 0 to III Breast Cancer

  • 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


Inclusion criteria
Inclusion criteria Mindfulness-Based Stress Reduction in Women with stages 0 to III Breast Cancer

  • 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


Exclusion criteria
Exclusion Criteria Mindfulness-Based Stress Reduction in Women with stages 0 to III Breast Cancer

  • 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


Recruitment method
Recruitment method Mindfulness-Based Stress Reduction in Women with stages 0 to III Breast Cancer

  • 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


Stages of breast cancer at diagnosis
Stages of breast cancer at diagnosis Mindfulness-Based Stress Reduction in Women with stages 0 to III Breast Cancer

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%)


Measurement tools
Measurement Tools Mindfulness-Based Stress Reduction in Women with stages 0 to III Breast Cancer

  • 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


Mbsr programme
MBSR programme Mindfulness-Based Stress Reduction in Women with stages 0 to III Breast Cancer

  • 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)


Number and sizes of classes
Number and sizes of classes Mindfulness-Based Stress Reduction in Women with stages 0 to III Breast Cancer

  • Class sizes: Up to 22 participants

  • Pilot group

  • 7 cycles of 8 week programmes (13 groups)

  • Clinical supervision by phone


The rose room at the haven in london
The Rose Room Mindfulness-Based Stress Reduction in Women with stages 0 to III Breast Cancerat the Haven in London


Reception at the haven in london
Reception at the Haven in London Mindfulness-Based Stress Reduction in Women with stages 0 to III Breast Cancer


Home practice
Home Practice Mindfulness-Based Stress Reduction in Women with stages 0 to III Breast Cancer

  • 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


Profile of mood states primary outcome measure
Profile of Mood States Mindfulness-Based Stress Reduction in Women with stages 0 to III Breast Cancer(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


Poms statistically significant results from mbsr compared to controls using repeated measures anova
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


Fact quality of life measure
FACT - Quality of Life measure controls using

  • 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)


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


Clinical significance for fact from mbsr at t2 and t3
Clinical Significance for FACT from MBSR at T2 and T3 from MBSR compared to controls using

  • FACT-B

  • FACT-B TOI


WHO-5 Wellbeing Questionnaire from MBSR compared to controls using 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


Clinical significance for who 5
Clinical Significance for WHO-5 from MBSR compared to controls using

T1= weeks -2 to 0, T2= weeks 8 to 10, T3 = weeks 12 to 14


Increased hours mindfulness home practice predicted improved scores
Increased hours mindfulness home practice from MBSR compared to controls using 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).


Qualitative data feedback
Qualitative data feedback from MBSR compared to controls using

  • 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


Qualitative data from intervention group
Qualitative Data from Intervention Group from MBSR compared to controls using

  • In the intervention group, all participants questioned said that they had become more mindful as a result of MBSR.


A summary of themes from the qualitative data
A summary of themes from the qualitative data from MBSR compared to controls using


How mindfulness has helped mood state
How mindfulness has helped mood state from MBSR compared to controls using

  • ‘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’


How mindfulness helped with pain and symptoms
How mindfulness helped with pain and symptoms from MBSR compared to controls using

‘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.’


How mindfulness helped with perception and life
How mindfulness helped with from MBSR compared to controls using 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’


Final comments
Final comments from MBSR compared to controls using

‘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’


Questions
Questions? from MBSR compared to controls using


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