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

University of Rochester

Status: Terminated

Conditions: Cancer; Fatigue

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05743491

UG1CA189961 (U.S. NIH Grant/Contract)

T32CA102618 (U.S. NIH Grant/Contract)

STUDY00001111

Details and patient eligibility

About

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.

Full description

Primary Aim:

To collect preliminary data comparing the effects of a YOCAS©® intervention to standard care on changes in cancer-related fatigue among Hispanic cancer survivors immediately post-intervention.

Secondary Aims:

A) To collect preliminary data comparing the effects of a YOCAS©® intervention to standard care on changes in quality of life and physical functioning.

OUTLINE: Patients are randomized to 1 of 2 arms.

Arm 1 = Participants undergo standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition are offered the 4-week YOCAS©® program gratis after completing all study requirements.

Arm 2 = Participants 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Standard Care

Experimental group

Description:

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.

Treatment:

Other: Standard Care

YOCAS©®

Experimental group

Description:

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.

Treatment:

Behavioral: YOCAS©®