Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy in Reducing Insomnia in Cancer Survivors

PRIMARY OBJECTIVES:

I. To determine if Yoga for Cancer Survivors (YOCAS) is effective for improving
patient-reported insomnia (Insomnia Severity Index) compared to Cognitive Behavioral Therapy
for Insomnia (CBT-I) and a health education control immediately post intervention.

SECONDARY OBJECTIVES:

I. To examine if YOCAS is effective for improving objective symptoms of insomnia (sleep
latency, sleep efficiency, wake after sleep onset, sleep duration, and daytime napping via
actigraphy) and global sleep quality impairment (Pittsburgh Sleep Quality Index) compared to
CBT-I and a health education control.

II. To examine if YOCAS and CBT-I are effective for maintaining improvements in insomnia
(Insomnia Severity Index) 3 and 6 months post intervention compared to a health education
control.

TERTIARY OBJECTIVES:

I. To explore whether YOCAS is effective for improving circadian activity rhythms (24 and 12
hour amplitudes and acrophases measured via actigraphy), physical function (i.e.,
cardiopulmonary [6-minute (min.) walk] and muscular function [dynamometry]), and inflammation
(interleukin [IL]-6, IL-8, IL-10, IL-1beta, interferon [IFN]-gamma, & tumor necrosis factor
receptor [TNFR]1 via standardized enzyme-linked immunosorbent assay [ELISA]s) compared to
CBT-I and a health education control.

II. To explore whether changes in circadian activity rhythms, physical function and
inflammation mediate the effect of YOCAS on insomnia.

III. To explore the time-varying nature of physical activity behavior after cancer treatment
and develop a new methodological approach to jointly model longitudinally measured exposures
and outcomes subject to measurement error and modification by personal characteristics in a
physical activity intervention study.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients undergo the YOCAS intervention comprising 18 specific physical postures and
mindfulness exercises focused on breathing and meditation and meet with the yoga instructor
over 75 minutes 2 times a week for 4 weeks.

ARM II: Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep
restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a
health professional over 90 minutes once a week for 8 weeks.

ARM III: Patients attend survivorship health education sessions over 75 minutes 2 times a
week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship
educational recommendations delivered by a community health educator. Patients also receive a
booklet entitled, "Cancer Survivorship Next Steps for Patients and Their Families."

After completion of study, patients are followed up at 3 and 6 months.

Inclusion Criteria:

- Have a confirmed diagnosis of cancer

- Have received surgery, chemotherapy, and/or radiation therapy

- Have completed all surgery, chemotherapy and/or radiation therapy within the last 2-60
months

- Meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-V criteria for
insomnia and score >= 10 on the Insomnia Severity Index

- Be able to read and understand English

- Be able to provide written informed consent

Exclusion Criteria:

- Have contraindications to functional testing or yoga participation according to the
treating physician

- Have practiced yoga >= 1 day a week within the 3 months prior to enrolling in the
study

- Be planning to start yoga on their own during the time they are enrolled in the study

- Have a confirmed diagnosis of sleep apnea or restless leg syndrome

- Be receiving any form of treatment for cancer with the exception of hormonal or
biologic therapy

- Have distant metastases