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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05743491
• Other study ID #: STUDY00001111
• Secondary ID: UG1CA189961T32CA
• Status: Terminated
• Phase: N/A
• Start date: April 12, 2023
• Est. completion date: August 16, 2023

Study information

• Verified date: August 2023
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: August 16, 2023
• Est. primary completion date: August 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Fatigue

Intervention

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.

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.

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)