Comparing Virtual Yoga to Standard Care on Insomnia Among Cancer Survivors

University of Rochester

Status: Active, not recruiting

Conditions: Insomnia

Treatments: Behavioral: YOCAS©® yoga; Other: Standard Care

Study type: Interventional

Funder types: Other

Identifiers

NCT04458194

STUDY00004405

Details and patient eligibility

About

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.

Full 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)

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

Standard Care

Active Comparator group

Description:

Cancer survivors receive their standard care

Treatment:

Other: Standard Care

YOCAS

Experimental group

Description:

Cancer survivors receive 8 virtual yoga sessions (75 minutes/session, 2 times a week for 4 weeks) delivered via an electronic platform (e.g., Zoom)

Treatment:

Behavioral: YOCAS©® yoga