Anava Wren, Ph.D. Stanford University Medical Center

Transcription

1 Investigating the Efficacy of a Lovingkindness Meditation Intervention for Patients Undergoing Breast Cancer Surgery: A Randomized Controlled Pilot Study Anava Wren, Ph.D. Stanford University Medical Center Rebecca Shelby, Ph.D., Zenzi Huysman, M.A., Katie Perlman, Mary Scott Soo, M.D., Francis Keefe, Ph.D. Duke University Medical Center

2 Background Surgery is a critical component of breast cancer treatment Common treatment-related symptoms: Need for a brief, peri-surgical psychosocial intervention for breast cancer patients Emotional distress (e.g., anxiety, depression) Physical symptoms (e.g., pain, nausea, fatigue, sleep disturbance) Limited research investigating psychosocial interventions during surgical time frame Positive psychosocial resources have predicted positive adjustment during peri-surgical time frame

3 Lovingkindness Meditation: A New Direction for Psychosocial Peri-Surgical Protocols Lovingkindness meditation (LKM) is an ancient Buddhist practice Developing positive emotions (e.g., love, compassion) towards oneself and others & releasing negative emotions Silent repetition of phrases May I be safe; May I be happy; May I be healthy; May I live with ease Brief psychosocial intervention that has the potential lead to psychological and physical well-being in the peri-surgical time frame Decrease in emotional distress, physical symptoms Increase in positive adjustment

4 Primary Aims: Study AIMS & Hypotheses: Assess the efficacy of a lovingkindness meditation (LKM) protocol on mood and anxiety during biopsy and the peri-surgical period of breast cancer compared to an active control (music) and standard of care Decrease anxiety Improve mood Assess the efficacy of a lovingkindness meditation (LKM) protocol on negative physical symptoms during biopsy and the peri-surgical period of breast cancer compared to an active control (music) and standard of care Improve physical outcomes (i.e., pain, fatigue, sleep disturbance, blood pressure, heart rate) Exploratory Aim: Assess whether there is evidence for the Broaden-and-Build hypotheses (i.e., building personal resources) Higher levels of psychological, cognitive, and social resources

5 Participant Characteristics (N=56) Age 56 ± Education M ± SD N (%) High School 3 (6.2%) Some College 11 (22.9%) College 16 (33.3%) Some Graduate School 5 (10.4%) Graduate Degree 13 (27.1%) Race Caucasian 39 (73.6% ) African American 12 (22.6%) Asian American 2 (3.8%) Married/Partner 32 (62.7%) Comorbid Condition (e.g., pain, CAD) 38 (68.7%) History of Anxiety/Depression 9 (17.9%) Diagnosed with cancer before biopsy 11 (19.6%) Surgery Lumpectomies 36 (64.3%) Mastectomies 20 (35.7%)

6 Study Design

7 Study Measures Variables Measure α Respons e Scale Anxiety State Anxiety Scale of STAI (20-item).94 1 to 4 Mood Cohen s Affect Scale (12-item) PA (.92) NA (.85) 1 to 4 Body Pain Brief Pain Inventory Scale (4-item).88 0 to 10 Breast Pain Adapted BPI (2-item).89 0 to 10 Fatigue FACIT Fatigue (13-item).91 0 to 4 Sleep Disturbance PROMIS SD (6-item).90 1 to 5 Self-Compassion Self-Compassion Scale (12-item).88 1 to 5 Coping Brief-Cope (28-item) AC (.88) MC (.78) Emotion Regulation Emotion Regulation Questionnaire (10-item) R (.89) S (.73) 1 to 4 1 to 7 Mindfulness Five Facet Mindfulness Questionnaire (23-item) to 5 Social Support PROMIS Emotional Support & PROMIS Social Isolation ES (.98) SI (.96) 1 to 5 Blood Pressure & Pulse Automatic inflation blood pressure monitor (upper extremity)

8 Results: Primary Outcomes Anxiety Significant treatment x time interaction (B=2.69, SE=1.33, t=2.02, p=0.05)

9 Results: Primary Outcomes Body Pain Significant treatment x time interaction (B=0.45, SE=0.21, t=2.10, p=0.04)

10 Results: Primary Outcomes Heart Rate Significant treatment x time interactions: (B=4.24, SE=1.70, t=2.50, p=0.02) & (B=3.31, SE=1.61, t=2.05, p=0.05)

11 Results: Exploratory Outcomes Self-Compassion Significant treatment x time interaction (B=-0.22, SE=0.07, t=-3.00, p=0.004)

12 Summary of Key Findings Patients randomly assigned to the lovingkindness meditation condition showed: Improvements in anxiety over time compared to the standard care (SC) condition There was a significant reduction in anxiety over time among those who practiced LKM Improvements in self-compassion and mindfulness over time compared to the music condition Maintenance of baseline levels of body pain over time relative to the SC condition Maintenance of baseline levels of emotional suppression and social isolation over time relative to the music condition There was a significant reduction in emotional suppression over time among those who practiced LKM Maintenance of baseline levels of heart rate over time relative to the music and SC conditions There was a significant reduction in heart rate over time among those who practiced LKM

13 Qualitative Feedback on Lovingkindness Meditation Helped patients relax, slow down, center, balance, find a safe space Helped patients think more positively, practice acceptance, reduce worry thoughts/anxiety, think clearly, and feel more positive and connected to others Helped patients distract from pain and feel less pain (related to treatment) Helped patients cope during medical appointments (e.g., prior to sentinel lymph node biopsy/surgery, surgical evaluations, chemotherapy) & with cancerrelated news (e.g., receipt of a result)

14 Overall, this study offered preliminary evidence that a brief lovingkindness meditation protocol can improve emotional distress and negative physical symptoms during the peri-surgical period of breast cancer, as well as increase positive psychosocial resources.

15 Future Implications Research Clinical Practice

16 Acknowledgments Francis Keefe, Ph.D. Rebecca Shelby, Ph.D. Mary Scott Soo, M.D., Jennifer Jarosz, M.D., Zenzi Huysmans, B.S., Mary Brantley, LMFT, & the Breast Imaging Team Timothy Strauman, Ph.D. Clive Robins, Ph.D. Jeffrey Brantley, M.D. All of the patients who dedicated their time to this study

17 Questions

18 Study Flow

19 Table 2

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21 Table 3

22 Study Flow

23 Results: Exploratory Outcomes Emotional Suppression Significant treatment x time interaction (B=-0.23, SE=0.12, t=-1.85, p=0.07)

24 Results: Exploratory Outcomes Mindful Awareness Significant treatment x time interaction (B=-2.57, SE=1.00, t=- 2.56, p=0.01) Mindful Non-Judgment Significant treatment x time interaction (B=-2.58, SE=1.25, t=-2.07, p=0.04)

25 Results: Exploratory Outcomes Social Isolation Significant treatment x time interaction (B=1.89, SE=0.88, t=2.15, p=0.04)

26 Table 2

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29 Table 4

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32 Table 5

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38 Table 6

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44 Table 7

45 Study Measures Mood Anxiety Body Pain Breast Pain Vasovagal Symptoms Fatigue Sleep Disturbance Self-Compassion Coping Emotion Regulation Mindfulness Social Support Physiological Reactivity Surgery Variables Adherence

46 Mediation Model Anxiety Self-Compassion Group (Med vs. SC) 1.96 (1.37) Anxiety Indirect Effect: z=1.81, p=0.07 (Trend for mediation)

47 Mediation Model Emotional Suppression Self-Compassion Group (Med vs. Music) -0.02(0.13) Emotional Suppression Indirect Effect: z=3.79, p<0.001 (Suggests mediation)

48 Mediation Model Mindful Awareness Self-Compassion Group (Med vs. Music) -0.91(1.11) Mindful Awareness Indirect Effect: z=-2.72, p=0.01 (Suggests mediation)

49 Mediation Model Mindful Non-Judgment Self-Compassion Group (Med vs. Music) -0.29(1.37) Mindful Non- Judgment Indirect Effect: z=-3.06, p=0.002 (Suggests mediation)

50 Mediation Model Social Isolation Self-Compassion Group (Med vs. Music) 0.80 (0.95) Social Isolation Indirect Effect: z= 2.19, p=0.02 (Suggests mediation)

51 Day of Biopsy Outcomes STAI State Anxiety Pre Biopsy Post Biopsy Standard Care Music Meditation

52 Day of Biopsy Outcomes Fatigue Standard Care Music Meditation 2 0 Pre Biopsy Post Biopsy

53 Day of Biopsy Outcomes Biopsy Pain Standard Care Meditation Music

54 The Breast Biopsy Experience: Relationship between Anxiety, Anticipatory Pain and Psychological Variables

55 Study Variable Measure Description of Measure Time Points Reliability and Validity References Appendix Page # s Mood Cohen s Positive and Negative Mood Scale Measures positive and negative mood Baseline, Post-Biopsy, Post- Result, Post-Surgery Cohen et al., 2006 p. 1 Anxiety Body Pain State Anxiety Scale of the State-Trait Anxiety Inventory Brief Pain Inventory- Intensity Scale; Pain Unpleasantness; Pain Duration Ongoing Breast Pain; Continuing Breast Pain Measures state level of anxiety Measures pain intensity and unpleasantness, and duration of bodily pain Baseline, Post-Biopsy, Post- Result, Post-Surgery Baseline, Post-Biopsy, Post- Result, Post-Surgery Breast Pain Measures ongoing and Baseline, Post-Result, Postcontinuing breast pain Surgery Nausea Nausea Scale Measures nausea Baseline, Post-Biopsy, Post- Result, Post-Surgery Fatigue FACIT Fatigue Measures fatigue Baseline, Post-Biopsy, Post- Result, Post-Surgery Sleep Disturbance Physiological Reactivity Self-Compassion PROMIS Sleep Disturbance Blood Pressure and Heart Rate Self-Compassion Scale Short-Form Brief measure of sleep disturbance Physiologic measures of blood pressure and pulse Brief measure of selfcompassion Pre-Biopsy, Post-Result, Post-Surgery Baseline, Post-Biopsy, Pre- Surgery, Post-Surgery; Surgical Follow-Up Visit Baseline, Post-Biopsy, Post- Result, Post-Surgery Coping Brief COPE Measure of coping Post-Biopsy, Post-Result, Post-Surgery Emotion Emotion Regulation Measure of emotion regulation Baseline, Post-Biopsy, Post- Regulation Questionnaire Result, Post-Surgery Mindfulness Five Facet Mindfulness Measure of mindfulness Post-Biopsy, Post-Result, Questionnaire Post-Surgery Social Support PROMIS Social Isolation, Two measures of social support Post-Biopsy, Post-Result, PROMIS Emotional Support Post-Surgery Health Care Utilization Electronic Patient Records Measure of pain medication use during surgery, length of surgery, and cost of care Pre- to Post-Surgery (During Hospital Visit) Speilberger, 1983 p. 2 Cleeland & Ryan, 1994; Jensen, Karoly, & Braver, 1986; Price, et al., 1983 p. 3-4 N/A Designed for study p. 5 Montgomery et al., 2007 p. 6 Reese, Shelby, & Abernethy, 2011 p. 7 Buysse et al., 2010 p. 8 N/A Neff et al., 2005; Neff, 2003 N/A p. 9 Dougall et al., 2009 p. 10 Gross & John, 2003 p. 11 Baer et al., 2008 p. 12 (Cella et al., 2007; Reeve et al., 2007 Adherence Adherence Measure Measures Adherence Post-Result, Post-Surgery N/A Designed for study p. 15 N/A p N/A

56 Effects of Positive Emotions in the Context of Breast Cancer Surgery Undoing Effect Decreased emotional distress, physiological reactivity (e.g., blood pressure, heart rate) Decreased negative physical symptoms (i.e., pain, nausea, fatigue, sleep disturbance) Broadening Effect Utilization of a broader coping repertoire Building Effect Increased selfcompassion Increased coping repertoire Increased emotion regulation Increased mindfulness Increased social support Decreased physical symptoms

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58 Key Points from Review: Section 1 Empirical literature has demonstrated that: Emotional distress in peri-surgical period has predicted post-surgery (e.g., emotional distress, pain, nausea, fatigue, discomfort, immune changes, analgesic use) Positive psychosocial resources in the peri-surgical period (e.g., optimism, hope, positive coping variables) have predicted (i.e., improvement in emotional distress, well-being, immune markers)

59 Key Points from Review: Section 2 Psychosocial peri-surgical interventions Strengths: Preliminary efficacy and feasibility data Limitations: Lack of theoretical focus Lack of emphasis on positive psychosocial resources Post-surgical interventions: CBT & MBSR Strengths: Focus on cultivation/assessment of positive psychosocial resources Efficacy data Limitations: Length of intervention

60 Key Points from Review: Section 3 Fredrickson s Broaden-and-Build theory indicates may provide a valuable conceptual framework for psychosocial perisurgical interventions for breast cancer patients Lovingkindness meditation (LKM)-based peri-surgical protocol could lead to the cultivation of positive emotions Research has demonstrated initial efficacy of LKM interventions in healthy and clinical populations Research has shown initial efficacy of a brief LKM intervention