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Karen M. Mustian, Ph.D., M.P.H. Assistant Professor Director PEAK CORE Lab Department of Radiation Oncology University of Rochester Cancer Center Funding: NCI U10CA037420 & OCCAM U10 CA037420-20S1 YOCAS ® Yoga Significantly Improves Sleep, Fatigue and Quality of Life in 410 Cancer Survivors : A URCC CCOP Research Base RCT
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Karen M. Mustian, Ph.D., M.P.H. Assistant Professor Director PEAK CORE Lab Department of Radiation Oncology University of Rochester Cancer Center Funding:

Jan 29, 2016

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Page 1: Karen M. Mustian, Ph.D., M.P.H. Assistant Professor Director PEAK CORE Lab Department of Radiation Oncology University of Rochester Cancer Center Funding:

Karen M. Mustian, Ph.D., M.P.H.Assistant Professor

Director PEAK CORE Lab Department of Radiation Oncology

University of Rochester Cancer CenterFunding: NCI U10CA037420

& OCCAM U10 CA037420-20S1

YOCAS® Yoga Significantly Improves Sleep, Fatigue and Quality of Life in 410 Cancer

Survivors : A URCC CCOP Research Base RCT

Page 2: Karen M. Mustian, Ph.D., M.P.H. Assistant Professor Director PEAK CORE Lab Department of Radiation Oncology University of Rochester Cancer Center Funding:

Study AimsPrimary Aim• To examine the efficacy of yoga

for improving sleep qualitysleep quality in cancer survivors

Secondary Aims• To examine the efficacy of yoga

for improving fatiguefatigue and quality of lifequality of life in cancer survivors

Page 3: Karen M. Mustian, Ph.D., M.P.H. Assistant Professor Director PEAK CORE Lab Department of Radiation Oncology University of Rochester Cancer Center Funding:

Central Illinois CCOPColumbia River CCOPHematology-Oncology of CNY CCOPSanta Rosa CCOPSoutheast Cancer Control ConsortiumKansas City CCOPGrand Rapids CCOPGreenville CCOPWichita CCOP

URCC

CCOPs

URCC CCOP Research Base: YOCAS ® Recruitment Sites

Page 4: Karen M. Mustian, Ph.D., M.P.H. Assistant Professor Director PEAK CORE Lab Department of Radiation Oncology University of Rochester Cancer Center Funding:

Eligibility CriteriaStudy participants must:

• Have cancercancer• Have undergone standard treatment for cancer standard treatment for cancer • Have completed all standard treatment completed all standard treatment

between 2 and 24 months priorbetween 2 and 24 months prior• Have sleep disturbance of a level 3 sleep disturbance of a level 3 or greater• Read EnglishEnglish • 21 years 21 years or older• Give written consentconsent

Study participants must not:• Have regularly participated in yoga classes regularly participated in yoga classes

within 3 months prior within 3 months prior • Have sleep apneasleep apnea• Have metastaticmetastatic cancer

Page 5: Karen M. Mustian, Ph.D., M.P.H. Assistant Professor Director PEAK CORE Lab Department of Radiation Oncology University of Rochester Cancer Center Funding:

• Arm 1: Standard Care

• Arm 2: Yoga plus Standard Care

• EligibilitEligibility• Consent• On-study

forms• Assess

sleep (PSQI), fatigue (MFSI), QOL (FACIT)

• Randomize

• Assess sleep, fatigue, QOL

• End study

Study Week 1(Baseline)

Study Weeks 2–5 (Intervention)

Study Week 6 (Post)

Schema

Page 6: Karen M. Mustian, Ph.D., M.P.H. Assistant Professor Director PEAK CORE Lab Department of Radiation Oncology University of Rochester Cancer Center Funding:

YOCAS® Intervention• Yoga

– Gentle Hatha Yoga– Restorative Yoga

• Components– Postures (asanas): seated, standing, transitional and supine – Breathing exercises (pranayama): slow, diaphragmatic– Mindfulness (awareness): meditation, visualization &

affirmation

• Duration– 4 weeks– 2 times a week for 75 minutes

• Standardization– URCC CCOP Yoga Consultant– Yoga Alliance-Certified Instructors– Yoga Instructional DVD– Yoga Instructional Manual

Page 7: Karen M. Mustian, Ph.D., M.P.H. Assistant Professor Director PEAK CORE Lab Department of Radiation Oncology University of Rochester Cancer Center Funding:

YOCAS® Intervention

Page 8: Karen M. Mustian, Ph.D., M.P.H. Assistant Professor Director PEAK CORE Lab Department of Radiation Oncology University of Rochester Cancer Center Funding:

• Diagnosis– Breast: N =307 (75%)– Other: N =103 (25%)

• Baseline Sleep Quality* – Yoga = 9.0– Control = 9.2

• N = 204 Control, 206 Yoga

• Mean age = 54 years

• Female N = 393 (96%)

• Caucasian N = 383 (93%)

Demographics (N=410)

•Both groups met the clinical cutoff criteria for impaired sleep quality (PSQI >5)

Page 9: Karen M. Mustian, Ph.D., M.P.H. Assistant Professor Director PEAK CORE Lab Department of Radiation Oncology University of Rochester Cancer Center Funding:

0%

5%

10%

15%

20%

25%

30%

35%

0 1 2 3 4 5 6 7 8

Perc

ent

Compliance (N = 410)86% > 5 sessions

% Y

oga

Ses

sio

ns A

tten

ded

Yoga Sessions

Page 10: Karen M. Mustian, Ph.D., M.P.H. Assistant Professor Director PEAK CORE Lab Department of Radiation Oncology University of Rochester Cancer Center Funding:

Results (N = 410)

-20 -10 0 10 20 30 40 50

Percent Improvement

Yoga Sleep Medications

Control

Daytime Sleepiness

Control Yoga

Sleep Quality Control Yoga

Fatigue Control Yoga

QOL Control Yoga

P < 0.05

P < 0.05

Page 11: Karen M. Mustian, Ph.D., M.P.H. Assistant Professor Director PEAK CORE Lab Department of Radiation Oncology University of Rochester Cancer Center Funding:

• Sleep quality–Yoga subjects improved sleep

quality by 22% while control subjects improved by 12% (p<0.05)

Sleep Quality (N = 410)

Page 12: Karen M. Mustian, Ph.D., M.P.H. Assistant Professor Director PEAK CORE Lab Department of Radiation Oncology University of Rochester Cancer Center Funding:

• Baseline sleep quality– 84% of the yoga subjects and 83% of the

control subjects had clinically impaired sleep quality at baseline (PSQI > 5)

• Sleep quality recovery – 31% of the yoga subjects recovered (PSQI <

5), while only 16% of the control subjects recovered (p<0.05)

Sleep Quality Recovery(N = 410)

Page 13: Karen M. Mustian, Ph.D., M.P.H. Assistant Professor Director PEAK CORE Lab Department of Radiation Oncology University of Rochester Cancer Center Funding:

• Fatigue– Yoga subjects reduced fatigue by 42%

while control subjects reduced fatigue by 12% (p<0.05)

• Quality of life– Yoga subjects improved quality of life

by 6% while control subjects improved quality of life by 0% (p<0.05)

Fatigue, & QOL (N = 410)

Page 14: Karen M. Mustian, Ph.D., M.P.H. Assistant Professor Director PEAK CORE Lab Department of Radiation Oncology University of Rochester Cancer Center Funding:

• Daytime sleepiness– Yoga subjects reduced daytime sleepiness

by 29% while control subjects reduced daytime sleepiness by 5% (p<0.05)

• Sleep medication use– Yoga subjects reduced sleep medication use

by 21% while control subjects increased sleep medication use by 5% (p<0.05)

Daytime Sleepiness & Medication Use (N = 410)

Page 15: Karen M. Mustian, Ph.D., M.P.H. Assistant Professor Director PEAK CORE Lab Department of Radiation Oncology University of Rochester Cancer Center Funding:

• YOCAS® Yoga was found effective for improving– Sleep quality– Fatigue– Quality of life– Daytime sleepiness– Reducing Sleep Medication Use!

Summary

Page 16: Karen M. Mustian, Ph.D., M.P.H. Assistant Professor Director PEAK CORE Lab Department of Radiation Oncology University of Rochester Cancer Center Funding:

• Gary Morrow, Ph.D., M.S.• Jim Atkins, M.D. • Luke Peppone, Ph.D.• Michelle Janelsins, Ph.D.• Oxana Palesh, Ph.D.,

M.P.H.• Lisa Sprod, Ph.D.• Supriya Mohile, M.D.• Charles Heckler, Ph.D.• Jane Hickok, M.D.

• Marget Braun, R.Y.T.• Leslie Gillies, C.R.C.• Jennifer Yates, M.S.• Jacque Lindke, C.R.C• Ryan Jones• Sebastian Estaque• Ann Wiater• NCI & OCCAM• URCC CCOP Affiliates

Acknowledgments

Page 17: Karen M. Mustian, Ph.D., M.P.H. Assistant Professor Director PEAK CORE Lab Department of Radiation Oncology University of Rochester Cancer Center Funding:

Yocas pictures