Principal Investigator

Karen M.
Awardee Organization

University Of Rochester
United States

Fiscal Year
Activity Code
Early Stage Investigator Grants (ESI)
Not Applicable
Project End Date

Yoga Versus CBT-I for Insomnia in Cancer Survivors and Biobehavioral Mechanisms

Up to 90% of cancer survivors report insomnia or some form of sleep quality impairment (SQI) post-treatment which co-occurs with dysregulated circadian rhythm, impaired physical function, chronically up-regulated inflammatory responses, and, when severe, increased cancer morbidity and mortality. Despite the ubiquity of insomnia and SQI, they are under-diagnosed and under-treated in cancer survivors. Yoga is a well-tolerated exercise intervention with promising preliminary evidence for its efficacy in improving insomnia and SQI. Our previous multicenter, phase III, randomized, controlled, trial (RCT) in 410 cancer survivors from 12 community oncology practices in the U.S., showed that our standardized Yoga intervention (YOCAS(c)(R): 4 wks, 2x/wk, 75 min/sess) produced moderate to large improvements in insomnia and SQI while also improving circadian activity rhythms. Yoga participants also decreased, while control participants increased, sleep medication use. Adherence to YOCAS(c)(R) was good (80%) with no study-related adverse events, and 100% of participants found YOCAS(c)(R) useful and would recommend it to other survivors. The next logical empirical steps, in line with NCI research priorities to develop effective, evidence-based, supportive care interventions for survivors, are t compare the YOCAS(c)(R) intervention to a gold-standard treatment (i.e., Cognitive Behavioral Therapy for Insomnia [CBT-I]) and a time and attention placebo control. Therefore, we propose to conduct a multicenter, 3-arm, blinded, phase III RCT comparing the effect of Arm 1) our YOCAS(c)(R) program, Arm 2) CBT-I, and Arm 3) a health education control on insomnia in 630 cancer survivors 6-12 months following adjuvant treatment using valid measures and analytical techniques. YOCAS(c)(R) and CBT-I will be delivered in groups using standard effective clinical formats (i.e., YOCAS(c)(R) = 2x/wk in 75-minute sessions over 4 weeks; CBT-I 1x/wk in 90-minute sessions over 8 weeks). Health education will also be delivered in groups and matched for equal time and attention to YOCAS(c)(R). We will require participants to meet DSM-IV insomnia criteria and the clinical cut off score for insomnia of >10 on the Insomnia Severity Index (ISI), assess the 3- and 6-month sustainability of insomnia benefits, and examine possible conceptually based biological mechanisms (circadian activity rhythms, physical function, and inflammation) that may influence insomnia via YOCAS(c)(R). We hypothesize YOCAS(c)(R) will be as effective as CBT-I and more effective than health education for improving insomnia, SQI, circadian activity rhythms, physical function, and inflammation; insomnia improvements will be sustained 3 and 6 months later in the YOCAS(c)(R) and CBT-I groups but not in the health education group; and changes in circadian activity rhythms, physical function, and inflammation will mediate the effects of YOCAS(c)(R) on insomnia. This is the first phase III, blinded RCT to test: 1) the effectiveness of YOCAS(c)(R) compared to CBT-I and a health education control for improving insomnia and SQI, 2) the 3- and 6-month sustainability of insomnia benefits from YOCAS(c)(R), and 3) the role of specific biological mediators in the efficacy of YOCAS . (c)(R)


  • Mustian KM, Cole CL, Lin PJ, Asare M, Fung C, Janelsins MC, Kamen CS, Peppone LJ, Magnuson A. Exercise Recommendations for the Management of Symptoms Clusters Resulting From Cancer and Cancer Treatments. Seminars in oncology nursing. 2016 Nov;32(4):383-393. Epub 2016 Oct 21. PMID: 27776835
  • Mustian KM. Yoga as Treatment for Insomnia Among Cancer Patients and Survivors: A Systematic Review. European medical journal. Oncology. 2013 Nov 1;1:106-115. PMID: 25343044
  • Mustian KM, Sprod LK, Palesh OG, Peppone LJ, Janelsins MC, Mohile SG, Carroll J. Exercise for the management of side effects and quality of life among cancer survivors. Current sports medicine reports. 2009 Nov-Dec;8(6):325-30. PMID: 19904073
  • Lin PJ, Altman BJ, Gilmore NJ, Loh KP, Dunne RF, Bautista J, Fung C, Janelsins MC, Peppone LJ, Melnik MK, Gococo KO, Messino MJ, Mustian KM. Effect of Yoga and Mediational Influence of Fatigue on Walking, Physical Activity, and Quality of Life Among Cancer Survivors. Journal of the National Comprehensive Cancer Network : JNCCN. 2023 Feb;21(2):153-162.e2. PMID: 36791754
  • Mustian KM, Darling TV, Janelsins MC, Jean-Pierre P, Roscoe JA, Morrow GR. Chemotherapy-Induced Nausea and Vomiting. US oncology. 2008;4(1):19-23. PMID: 24761161
  • Mustian KM, Janelsins M, Peppone LJ, Kamen C. Yoga for the Treatment of Insomnia among Cancer Patients: Evidence, Mechanisms of Action, and Clinical Recommendations. Oncology & hematology review. 2014;10(2):164-168. PMID: 25861453
  • Lin PJ, Kleckner IR, Loh KP, Inglis JE, Peppone LJ, Janelsins MC, Kamen CS, Heckler CE, Culakova E, Pigeon WR, Reddy PS, Messino MJ, Gaur R, Mustian KM. Influence of Yoga on Cancer-Related Fatigue and on Mediational Relationships Between Changes in Sleep and Cancer-Related Fatigue: A Nationwide, Multicenter Randomized Controlled Trial of Yoga in Cancer Survivors. Integrative cancer therapies. 2019 Jan-Dec;18:1534735419855134. PMID: 31165647
  • Mustian KM, Alfano CM, Heckler C, Kleckner AS, Kleckner IR, Leach CR, Mohr D, Palesh OG, Peppone LJ, Piper BF, Scarpato J, Smith T, Sprod LK, Miller SM. Comparison of Pharmaceutical, Psychological, and Exercise Treatments for Cancer-Related Fatigue: A Meta-analysis. JAMA oncology. 2017 Jul 1;3(7):961-968. PMID: 28253393
  • Melton DI, Katula JA, Mustian KM. The current state of personal training: an industry perspective of personal trainers in a small Southeast community. Journal of strength and conditioning research. 2008 May;22(3):883-9. PMID: 18438226
  • Melton D, Dail TK, Katula JA, Mustian KM. Women's Perspectives of Personal Trainers: A Qualitative Study. The sport journal. 2011 Jan;14. (1). PMID: 26005398
  • Conley CC, Kamen CS, Heckler CE, Janelsins MC, Morrow GR, Peppone LJ, Scalzo AJ, Gross H, Dakhil S, Mustian KM, Palesh OG. Modafinil Moderates the Relationship Between Cancer-Related Fatigue and Depression in 541 Patients Receiving Chemotherapy. Journal of clinical psychopharmacology. 2016 Feb;36(1):82-5. PMID: 26658264
  • Sprod LK, Fernandez ID, Janelsins MC, Peppone LJ, Atkins JN, Giguere J, Block R, Mustian KM. Effects of yoga on cancer-related fatigue and global side-effect burden in older cancer survivors. Journal of geriatric oncology. 2015 Jan;6(1):8-14. Epub 2014 Oct 30. PMID: 25449185
  • Chandwani KD, Heckler CE, Mohile SG, Mustian KM, Janelsins M, Peppone LJ, Bushunow P, Flynn PJ, Morrow GR. Hot flashes severity, complementary and alternative medicine use, and self-rated health in women with breast cancer. Explore (New York, N.Y.). 2014 Jul-Aug;10(4):241-7. Epub 2014 Apr 18. PMID: 25037667
  • Lin PJ, Peppone LJ, Janelsins MC, Mohile SG, Kamen CS, Kleckner IR, Fung C, Asare M, Cole CL, Culakova E, Mustian KM. Yoga for the Management of Cancer Treatment-Related Toxicities. Current oncology reports. 2018 Feb 1;20(1):5. PMID: 29388071
  • Minasian L, Dimond E, Davis M, Adhikari B, Fagerstrom R, Fabian C, Floyd J, Unger JM, Douglas PS, Mustian KM, Chow EJ, Lipshultz S, Hundley WG, Armenian S, Ky B. The Evolving Design of NIH-Funded Cardio-Oncology Studies to Address Cancer Treatment-Related Cardiovascular Toxicity. JACC. CardioOncology. 2019 Sep;1(1):105-113. Epub 2019 Sep 24. PMID: 32529192
  • Mustian KM, Devine K, Ryan JL, Janelsins MC, Sprod LK, Peppone LJ, Candelario GD, Mohile SG, Morrow GR. Treatment of Nausea and Vomiting During Chemotherapy. US oncology & hematology. 2011;7(2):91-97. PMID: 24466408
  • Samuel SR, Maiya AG, Fernandes DJ, Guddattu V, Saxena PUP, Kurian JR, Lin PJ, Mustian KM. Effectiveness of exercise-based rehabilitation on functional capacity and quality of life in head and neck cancer patients receiving chemo-radiotherapy. Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2019 Oct;27(10):3913-3920. Epub 2019 Mar 27. PMID: 30919154
  • Saligan LN, Olson K, Filler K, Larkin D, Cramp F, Yennurajalingam S, Escalante CP, del Giglio A, Kober KM, Kamath J, Palesh O, Mustian K, Multinational Association of Supportive Care in Cancer Fatigue Study Group-Biomarker Working Group. The biology of cancer-related fatigue: a review of the literature. Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2015 Aug;23(8):2461-78. Epub 2015 May 15. PMID: 25975676

Clinical Trials

Study Name Clinical Trial ID
Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy in Reducing Insomnia in Cancer Survivors NCT02613364