Cancer
Conditions
Brief summary
The purpose of this study is to learn whether a yoga therapy program can improve quality of life and reduce symptoms in people undergoing stem cell transplantation compared with an enhanced standard care physical activity program.
Detailed description
Primary Objective: • Examine the efficacy of YT relative to SC on HSCT-specific QOL. Outcomes will be collected at baseline pre-transplant (pre-YT) and then day 0, 14, 30, 60, and 100 as well as 1-year post-transplant. Secondary Objectives and Endpoints: * Examine group differences in other patient-reported outcomes including general QOL and fatigue. * Explore group differences in psychosocial and functional outcomes and as possible mediators including stress, mental health (depression and anxiety), sleep disturbances, growth, self-efficacy, mindfulness, and objective functional measures as well as moderators of YT including demographic factors (sex, age, etc.), baseline psychosocial factors, and medical variables (e.g., autologous versus allogeneic transplant). * Explore YT's implementation through qualitative interviews.
Interventions
OTHERYoga Therapy (YT)
Yoga Therapy (YT) is an evidence-based mind-body practice recommended for cancer to relieve nausea, fatigue, pain, sleep disruption, psychosocial distress, musculoskeletal symptoms, and cognitive dysfunction, all common symptoms experienced during HSCT.
Sponsors
M.D. Anderson Cancer Center
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female cancer patients 2. Age 18 or older 3. Understand and read English 4. Scheduled to undergo their first autologous or allogeneic HSCT (even number of each) at MDA with a minimum of 2-week inpatient hospital stay 5. Be willing to follow protocol requirements 6. Sign a written informed consent
Exclusion criteria
1. Have extreme mobility issues that preclude participating in the Yoga program 2. Have major thought disorders such as schizophrenia or uncontrolled bipolar disorder 3. Have hematopoietic cell transplantation HCT comorbidity score of 3 or higher (excluding cancer)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Adverse Events (AEs) | Through study completion; an average of 1 year | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |
Countries
United States
Contacts
CONTACTLorenzo Cohen, PHD
PRINCIPAL_INVESTIGATORLorenzo Cohen, PHD
UT MD Anderson Cancer Center
Outcome results
None listed