Cancer Clinical Trial
Official title:
Yoga for Persistent Fatigue in the Survivors of Bone Marrow Transplantation: A Feasibility Study
Cancer-related fatigue (CRF) after hematopoietic cell transplantation (HCT) is a persistent problem that limits activities and causes distress. Considering the high prevalence of CRF among HCT survivors and the limitations of currently existing treatments, there is a pressing need for establishing safe and effective options for reducing CRF after HCT. Based on evidence supporting the use of yoga for CRF in non-HCT populations, yoga is one option worthy of evaluation for ameliorating CRF in HCT patients. Yoga is easy to implement, may be appealing to HCT patients, and can be self-administered, which would encourage long-term use and potentially lead to a better control of persistent CRF in HCT survivors. The primary aim of the proposed study is to assess the feasibility of a yoga intervention for HCT survivors with CRF. Outcomes from this feasibility study will provide the information needed to design a larger, adequately powered randomized controlled trial to evaluate yoga for CRF in HCT survivors. This study will employ a mixed-methods, single-arm, pretest-posttest design with focus groups. Twenty HCT survivors who report at least moderate fatigue will be recruited from the HCT clinic, Michigan Medicine. Participants will be enrolled in a six-week Restorative yoga program. The program will consist of a weekly, 60-minute yoga group class led by a certified yoga instructor along with twice-weekly home practice using yoga DVD.
OBJECTIVES
Primary Objective: To assess the feasibility of an organized yoga intervention for HCT
survivors with CRF.
Hypothesis: A trial of yoga in the HCT survivor population will be deemed feasible if at
least 75% of study subjects demonstrated protocol adherence rate of at least 80%.
Secondary Objectives:
- Explore participants' perceptions regarding yoga and physical activity
Hypothesis: HCT survivors will be positive about yoga and will express satisfaction with the
yoga program, as will be shown during focus groups that will be held at the end of the yoga
program.
- Evaluate the association between yoga practice and self-efficacy and self-regulation
Hypothesis: Adherence to yoga will be associated with higher self-efficacy and selfregulation
scores.
- Evaluate the changes in CRF scores from baseline to the end of the yoga program.
Hypothesis: CRF scores at the end of the yoga program will be lower than CRF scores at
baseline.
- Evaluate whether changes in CRF are associated with changes in depression, sleep
disturbances, physical activity, and pain.
Hypothesis 5: Improvement in CRF will be associated with increased physical activity and
decreased depression, sleep disturbances, and pain.
- Evaluate the safety of yoga practice in HCT survivors.
Hypothesis: Yoga will be considered as a safe intervention for CRF in HCT survivors as
demonstrated by the absence of adverse events or serious adverse events related to or
associated with yoga practice.
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