Clinical trial NCT05743491: Yoga Versus Standard Care for Reducing Fatigue in Hispanic Cancer Survivors (YOCAS©®)
Official title: A Feasibility Trial Comparing the Effectiveness of Yoga Versus Standard Care for Treating Fatigue in Hispanic Cancer Survivors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fatigue
Cancer
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-02-24
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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) ]
timeFrame: Baseline to post intervention (approximately 5 weeks)
Secondary outcomes:
measure: 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) ]
timeFrame: Baseline to post intervention (approximately 5 weeks)
measure: 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) ]
timeFrame: Baseline to post intervention (approximately 5 weeks)
measure: 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) ]
timeFrame: Baseline to post intervention (approximately 5 weeks)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References: