Yoga for Fatigue in the Survivors of Bone Marrow Transplantation
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Other Indications |
| Therapuetic Areas: | Oncology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/12/2018 |
| Start Date: | December 22, 2017 |
| End Date: | July 31, 2018 |
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.
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.
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.
Inclusion Criteria:
- Adult HCT survivors as defined by being at least 100 days post autologous or
allogeneic transplantation for a malignant disease. There is no restriction to
enrollment by donor type, donor cell source, presence or absence of graft versus host
disease.
- Age ≥ 18 years at the time of transplant.
- A history of persistent CRF as defined by a perception of general CRF for at least one
month before enrollment.
- A history of at least moderate CRF as defined by a CRF score of 4 or more on a
10-point Visual Analog Scale.
- Participants who are deemed qualified for yoga movements according to the Yoga
Qualifying Movements Screening Checklist (a checklist developed by researchers at the
University of California, Los Angeles to promote yoga safety through assessing the
eligibility of each patient)
Exclusion Criteria:
- A self-reported current practice of yoga or any other mind-body therapy, including but
not limited to meditation or hypnosis therapy in the past 30 days prior to study
enrollment.
- Subjects currently on supplemental oxygen support.
- Subjects currently receiving hemodialysis.
- Subjects currently admitted to an inpatient unit at Michigan Medicine.
- Subjects with an uncontrolled, active infection. Subjects with viremia
(Cytomegalovirus or other) may be enrolled, provided they are on active therapy and at
the discretion of the treating physician.
- Subjects who have relapsed after their autologous or allogeneic transplant.
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