Nursing, Integrative Oncology and Research: Rites of Passage

Transcription

1 Nursing, Integrative Oncology and Research: Rites of Passage Debra Barton RN, PhD, FAAN Mary Lou Willard French Professor of Nursing University of Michigan School of Nursing Ann Arbor, MI

2 Outline Why integrative therapy The evidence for hypnosis Ginseng a powerful plant

3 It s Complicated Dodd M, Janson S, Facione N, Faucett J, Froelicher ES, Humphreys J, Lee K, Miaskowski C, Puntillo K, Rankin S & Taylor D (2001) Journal of Advanced Nursing 33(5), Advancing the science of symptom management

4 Adapted from Ricardo Cruciani 2005 Beth Israel Medical Center, NY, NY Autonomic failure anemia Metabolic abnormalities stress cachexia depression Hypoxia anxiety Endocrine abnormalities Co-morbid drug Side effects Drug-induced Side effects Fatigue chemotherapy Radiation therapy Social support deconditioning infection Cardiac function cytokines activity Preexisting conditions diet pain dehydration Past life experiences

5 Integrative Medicine Healing oriented Addresses all aspects of the person Relationship based Acknowledgement: Univ AZ website

6 Adapted from Ricardo Cruciani 2005 Beth Israel Medical Center, NY, NY Autonomic failure anemia Metabolic abnormalities stress cachexia depression Hypoxia anxiety Endocrine abnormalities Co-morbid drug Side effects Drug-induced Side effects Fatigue chemotherapy Radiation therapy Social support deconditioning infection Cardiac function cytokines activity Preexisting conditions diet pain dehydration Past life experiences

7 Why Rites of Passage? Ceremonies involving teachings that mark transitional periods in life Teachings from over 30+ years of research and practice Listen, observe, contemplate, ask questions Constant evolution of thought and action

8 The hot flash story

9 What s in a Hot Flash Estrogen withdrawal Loss of thermoregulatory neutral zone Core body temperature increase (Freedman, Am J Hum Biol, 2001) Imbalance in norepinephrine/serotonin Preponderance of sympathetic activity and withdrawal of vagal activity (parasympathetic) (Thurston, Menopause, 2012) Meaning, stress precipitates (Barton D, Ganz P. Symptoms: Menopause, infertility and sexual health. Adv Exp Med Biol. 2015;862:115-41)

10 Psychosocial Components Important, But Not Enough 3 studies of CBT for hot flashes group, self-help, paced breathing, physical activity (Mann, Lancet Oncology, 2012; Ayers, Menopause, 2012; Duijts, JCO, 2012) Bother, interference, burden of hot flashes significantly decreased Frequency and severity did not

11 What is hypnosis? A state of consciousness involving focused attention and reduced peripheral awareness characterized by a capacity for response to suggestion. (Elkins, Amer J of Clin Hypnosis, 57, 2015) Hypnotherapy works best on issues not under conscious control and can address biology, cognitions and emotion

12 Change In Weekly Composite Hot Flash Scores Elkins et al., Menopause, Vol. 20, No. 3, 2013

13 Hypnosis/Venlafaxine for Hot Flashes Random Baseline week then 75 mg venlafaxine + self-hypnosis training/practice x 7 weeks Baseline week then 75 mg venlafaxine + focused attn training/practice x 7 weeks Baseline week then placebo pill + focused attn training/practice x 7 weeks Baseline week then placebo pill + self-hypnosis training/practice x 7 weeks Off study Supported by NCI and NCCAM R21 CA

14 Intervention Week 1: No intervention, baseline measure Weeks 2-5: Face to face visits, hypnosis or focused attention Weeks 6-8: At home practice, self-hypnosis or focused attention Hypnosis involved a trance like state and suggestions for cooling. Participants had a choice of snowy mountains or a cooling lake Focused attention consisted of white noise and instruction to focus attention on whatever the participant thinks will help hot flashes

15 100 Hot Flash Score Percent of Baseline Hypnosis/venlafaxine Venlafaxine/Focused attention Hypnosis/Placebo** Placebo/Focused attention N=71 **p=.04 compared to placebo/focused attention (Barton, Menopause 24 (7) , 2017)

16 Turning to Fatigue

17 Building on the work of B. Cimprich (CA Nursing, 1993, 2003) Developing hypnosis induction for fatigue Principles for restoring attention: Catch interest (fascination) Change from daily humdrum Not boring Enjoyable/pleasurable Involves NATURE

18 Hypnosis for Fatigue Feasibility N=6 Fatigue scores over 5 weeks

19 Sexual health definition and components State of physical, emotional, mental and social well-being in relation to sexuality Pertains to an individual as well as to a relationship

20 One possible predictor: body image stress Cross sectional study of women with gynecologic cancer (N=186) Body change stress and psychological symptoms were associated with sexual morbidity Fatigue and body image stress were significantly correlated (Levin Int J Gynecol Cancer, 20: , 2010)

21 Feasibility study data Variable Baseline 5 weeks change P value Mean ( S.D.) Mean (S.D.) Mean (S.D.) Impact of treatment scale (Range 0-65, lower is better) 37.6 (14.5) 24 (10.1) (12.1).02 Female Sexual Function Index: Overall score (2-36, higher is better) 10.2 (5.4) 20.8 (8.8) 10.7 (6.4).003 Women (N=11) recruited to the study had a mean age of 46, with a range of Women were a mean of 44 months from diagnosis and had been concerned about their self- image for about 28 months.

22 Phase II Schema 97 women with a decrease in self/body image since their cancer diagnosis and who wish to improve it; randomize 2:1 to hypnosis vs relaxation Hypnotic relaxation intervention in person every 2 weeks x 3; phone calls during week in between visits Progressive relaxation control in person every 2 weeks x 3; phone calls during week in between visits Primary outcome: Impact of treatment scale change from baseline to week 6

23 Hypnosis Session I: Assessment to determine the woman s key concerns and goals related to sexual health and response to induction. Ego strengthening and self-esteem focus of hypnosis. Session II: Individualization: focus on self-image during hypnosis. Session III: Empowerment: embrace herself in an accepting and loving way and to take charge of her sexuality during hypnosis. Choose new behavior. Therapist visits are every 2 weeks x 3 times total.

24 Relaxation control Session I - III: Assessment of sources of stress Education on progressive muscle relaxation and CD Evaluate barriers to practice Do progressive muscle relaxation led by research therapist

25 Eligibility - Inclusion Adult women with a history of cancer, any stage, with breast or gynecologic cancer. Women who report a change in their body/selfimage since diagnosis and wish to improve it. Two screening questions will be used: Has your body image or self-image changed in an unwanted way since your cancer diagnosis? Would you like to be able to do something to improve your body image or self-image?

26 Exclusion Criteria Diagnosis of a major depressive episode, an acute anxiety disorder, psychosis, PTSD, or schizophrenia Past history of sexual abuse. Currently on 2 or more antidepressant or antianxiety therapies for mood disturbance of any kind. Past use is allowed, just not current use.

27 Measures Impact of Treatment Scale body image stress Sexual self schema scale PROMIS global sexual satisfaction and interest Salivary collections for diurnal cortisol Data points: baseline and week 7 Accrual complete, analysis underway

28 New R01 My promise to cancer community Testing efficacy of a form of selfadministered hypnosis Hot flash endpoint will move to other symptoms if beneficial

29 Multicomponent care for sexual health Vaginal symptoms: Vaginal dehydroepiandosterone (DHEA) (Barton Supp Care in Cancer, in press) Body/self image: Cognitive behavioral approach using hypnosis (analysis in progress) Energy: Dopaminergic agent (study currently accruing), pursue hypnosis Partner issues: online interactive tool (to be developed)

30 Ginseng Genus: Panax, Araliaceae family, perennial plant Used in Traditional Chinese Medicine Requires 4+ years of growing Active constituents: ginsenosides Over 100 identified with biologic activity

31 Fatigue and Ginseng Fatigue etiology Immune system: inflammation pro-inflammatory cytokines Hypothalamic pituitary adrenal system: flattened cortisol slope blunted cortisol response acute stress decreased glucocorticoid response Decreased activity Ginsenoside activity Inhibits MAPkinase - MCF-7 cells Decreased HPA activation and proinflammatory cytokines in mice with LPS induced depression Increased aerobic endurance while exercising at 70% Vo2 max (Bower, JCO, 2013; Bower, JCO, 2011; Bower, Br Beh Imm, 2007; Bower, Psychoneurodendo,2005; Bower, Psychosomatic Med, 2005) (King & Murphy, Exp Ther Onc, 2007; Kang, Neuroinflamm, 2011; Wang, Planta Medica, 1998)

32 Schema Randomization Panax quinquefolius 2,000 mg by mouth BID for 8 weeks Matching Placebo by mouth BID for 8 weeks Ginseng was provided in capsules Both doses taken before noon Standardized to 3% ginsenoside content Funded by U10CA37404 and BCRF Barton et al, JNCI, 2013

33 Inclusion Eligibility Adults with fatigue 4 for 1 month, curative intent Other causes of fatigue ruled out (thyroid, anemia (hgb >11), pain, insomnia) Exclusion Chronic systemic steroids, opioids, infections Stop or start anti-cancer therapy Dietary supplements for fatigue

34 Primary Endpoint Multidimensional Fatigue Symptom Inventory Short Form (Stein, 2004) General Subscale: pooped, worn out, fatigued, sluggish, run down, tired 0 not at all to 4 extremely

35 MFSI-SF general subscale MFSI Mean Change from Baseline at 4 and 8 weeks Ginseng Placebo 10 p=.07 p= wks 8 wks

36 Other Fatigue Endpoints Change from baseline, 0-100, higher is better P=.08 P=.008 Ginseng Placebo 10 0 Fatigue/Inertia 4 wks Fatigue/Inertia 8 wks

37 Change in lab data by fatigue improvement ginseng group Biomarker 10 % improvement (N=37) No 10% Improvement (N=38) Adiponectin Mean (SD) 904 (3137) -274 (1844) 0.12 C-reactive protein Mean (SD) 0.0 (0.2) 0.1 (0.3) IL6 Mean (SD) 0.3 (1.8) 0.1 (1.2) IL1RA Mean (SD) 206 (1247) -319 (1003) sil6r Mean (SD) 625 (3691) -824 (4625) stnfr2 Mean (SD) 133 (885) 58 (871) TNF Mean (SD) 0.0 (0.7) 0.0 (0.4) p value

38 WI Ginseng Used Pure ground root, no extracts, no additives Interest in complementary activity of ginsenosides and possible additive effect to activity

39 2011 MFMER