Yoga Versus Standard Care for Reducing Fatigue in Hispanic Cancer Survivors (YOCAS©®)

NCT05743491 | Terminated

• 3 other identifiers: STUDY00001111UG1CA189961T32CA102618
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II 2-arm randomized controlled trial comparing yoga (Yoga for Cancer Survivors, YOCAS©®) to standard care in reducing cancer-related fatigue in Hispanic cancer survivors. Survivors randomized to Arm 1 will receive Standard Care and Arm 2 will receive standard care plus a four-week YOCAS©® intervention where Hispanic survivors attend yoga sessions together. Investigators will acquire preliminary data on cancer-related fatigue, as well as, secondary data on other common side effects.

Conditions

Fatigue; Cancer

Outcome Measures

Primary Outcomes (1)

• Mean Change in Fatigue as Measured by the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) Total Score Comparing YOCAS©® to Standard Care [Time Frame: Baseline up to post intervention (approximately 5 weeks) ]

  The MFSI is a multidimensional 30-item fatigue scale developed specifically for documenting cancer-related fatigue. The total MFSI-SF score ranges from -24 to 96, with a higher score indicating a higher fatigue level.

  Baseline to post intervention (approximately 5 weeks)

Secondary Outcomes (3)

• Mean Change in Quality of Life as measured by the Functional Assessment of Cancer Therapy-General (FACT-G) total score comparing YOCAS©® to Standard Care [Time Frame: Baseline up to post intervention (approximately 5 weeks) ]

  Baseline to post intervention (approximately 5 weeks)

• Mean Change in Physical Functioning as Measured by the 30-second chair stand comparing YOCAS©® to Standard Care [Time Frame: Baseline up to post intervention (approximately 5 weeks) ]

  Baseline to post intervention (approximately 5 weeks)

• Mean Change in Physical Functioning as Measured by the 30-second arm curl test comparing YOCAS©® to Standard Care [Time Frame: Baseline up to post intervention (approximately 5 weeks) ]

  Baseline to post intervention (approximately 5 weeks)

Study Arms (2)

Standard Care

EXPERIMENTAL

Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS©® program gratis after completing all study requirements.

Other: Standard Care

YOCAS©®

EXPERIMENTAL

YOCAS©® is a standardized yoga program designed specifically for use by cancer patients and survivors. The YOCAS©® program is a low to moderate intensity mode of exercise that draws from two basic types of yoga: gentle Hatha and Restorative yoga. The program includes 18 specific physical postures (asanas) and mindfulness exercises focused on breathing (pranayama) and meditation (dhyana). The program is designed to be delivered by certified yoga instructors in community settings, two times a week for 75 minutes over four weeks.

Behavioral: YOCAS©®

Interventions

Standard Care OTHER

Cancer survivors assigned to this condition continue with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS©® program gratis after completing all study requirements.

Also known as: Usual Care

Standard Care

YOCAS©® BEHAVIORAL

YOCAS©® is a standardized yoga program designed specifically for use by cancer patients and survivors. The YOCAS©® program is a low to moderate intensity mode of exercise that draws from two basic types of yoga: gentle Hatha and Restorative yoga. The program includes 18 specific physical postures (asanas) and mindfulness exercises focused on breathing (pranayama) and meditation (dhyana). The program is designed to be delivered by certified yoga instructors in community settings, two times a week for 75 minutes over four weeks.

YOCAS©®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 18 years of age
• Have a confirmed diagnosis of solid tumor or hematologic malignancy
• Have completed all chemotherapy, surgery, and/or radiation therapy within the last 2 years
• Have a score ≥4 on a 0-10 fatigue screening scale
• Be at least 18 years of age
• Self-identify as Latino/a or Hispanic
• Be able to read and understand English or Spanish
• Be able to provide written informed consent
• Have the ability to attend 8 yoga sessions in-person

You may not qualify if:

• Have contraindications to yoga participation per their primary physician or oncologist
• 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 distant metastases

Sponsors & Collaborators

• University of Rochester: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Fatigue; Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 24, 2023
• Study Start: April 12, 2023
• Primary Completion: August 16, 2023
• Study Completion: August 16, 2023
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

US (1)