Clinical trial NCT04458194: Comparing Virtual Yoga to Standard Care on Insomnia Among Cancer Survivors
Official title: A Feasibility Trial Comparing the Effectiveness of Virtual YOCAS©® Yoga to Standard Care for Treating Insomnia in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Insomnia
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Bassett Medical Center
First posted: 2020-07-07
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This feasibility phase II randomized controlled trial examines the preliminary efficacy of our standardized four-week YOCAS©® (Yoga for Cancer Survivors) intervention that is delivered virtually on insomnia and sleep quality in cancer survivors.

Insomnia can be described as excessive daytime napping, difficulty falling asleep, difficulty staying asleep, or waking up earlier than desired. The vast majority of patients with cancer experience some form of sleep impairment post-treatment. Yoga is safe, feasible, and effective for improving insomnia and sleep quality in cancer survivors. However, most of the yoga intervention was delivered in person. With the challenges and the social distancing regulation regarding the COVID-19 pandemic, adapting to virtual behavioral intervention is critically important and needed. Whether the yoga intervention delivered virtually to survivors provides a similar benefit of improving insomnia and sleep quality is unknown.

Detailed description: PRIMARY OBJECTIVE:

To compare the effects of virtual YOCAS©® intervention to standard care on changes in insomnia measured via the Insomnia Severity Index among cancer survivors

SECONDARY OBJECTIVE:

To compare the effects of virtual YOCAS©® intervention to standard care on changes in sleep quality measured via the Pittsburgh Sleep Quality Index among cancer survivors

OUTLINE: Cancer survivors are randomized to 1 of 2 arms.

ARM I: Standard Care: Cancer survivors receive their standard care

ARM II: YOCAS©® intervention: Cancer survivors participate in 8 virtual YOCAS sessions (75 minutes/session, 2 times a week for 4 weeks) delivered via the electronic platform (e.g., Zoom)

Eligibility criteria: Inclusion Criteria:

Cancer Survivors must:

* 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 months to 10 years
* score ≥4 on a 0-10 sleep screening scale
* be at least 18 years of age
* be able to read and understand English
* be able to provide informed consent
* have access to the internet and a smartphone, tablet, and/or computer
* have the ability to attend 8 virtual yoga sessions

Exclusion Criteria:

Cancer Survivor must not:

* have contraindications to yoga participation
* have practiced yoga 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

Primary outcomes:
measure: Mean change in insomnia as measured by the Insomnia Severity Index (ISI) total score comparing cancer survivors in YOCAS vs. Standard Care
timeFrame: baseline to week 5
Secondary outcomes:
measure: Mean Change in sleep quality as measured by the Pittsburgh Sleep Quality Inventory (PSQI) total Score comparing cancer survivors in YOCAS vs. Standard Care
timeFrame: baseline to week 5
Other outcomes:
Locations:
city: Cooperstown
country: United States
facility: Bassett Research Institute
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Karen Mustian, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: