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

A Feasibility Trial Comparing the Effectiveness of Yoga Versus Standard Care for Treating Fatigue in Hispanic Cancer Survivors

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.

Study Overview

• Status: Terminated
• Conditions: Cancer; Fatigue
• Intervention / Treatment: Other: Standard Care; Behavioral: YOCAS©®

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard Care; 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; 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.; Other Names: Usual Care
Experimental: YOCAS©®; 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©®; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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) ]	The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. The total FACT-G score ranges from 0-108 with a higher score indicating better quality of life.	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) ]	The participant is instructed to sit in the middle of a chair, cross their arms over their chest, keep their feet flat on the floor, and repeatedly raise to stand up and sit back down on the chair for 30 seconds. The number of times patients come to a full standing position in 30 seconds is recorded.	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) ]	Participants are instructed to be seated on an upright chair and asked to repeatedly lift a 5 lb weight (for women) or an 8 lb weight (for men) for 30 seconds. The number of lifts in 30 seconds is recorded.	Baseline to post intervention (approximately 5 weeks)

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2023
• Primary Completion (Actual): August 16, 2023
• Study Completion (Actual): August 16, 2023

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: STUDY00001111; UG1CA189961 (U.S. NIH Grant/Contract); T32CA102618 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No