Clinical trial NCT03299465: Yoga for Fatigue in the Survivors of Bone Marrow Transplantation
Official title: Yoga for Persistent Fatigue in the Survivors of Bone Marrow Transplantation: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Cancer
Keywords: bone marrow transplantation
yoga
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2017-10-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Practice log
timeFrame: Weekly during the six-week intervention period
Secondary outcomes:
measure: Side-effects/adverse events log
timeFrame: Weekly during the six-week intervention period
measure: Multidimensional Fatigue Symptom Inventory
timeFrame: At baseline (before treatment) and within 10 days of the last in-class yoga session
measure: PROMIS-SF-Fatigue
timeFrame: At baseline (before treatment) and within 10 days of the last in-class yoga session
measure: Brief Pain Inventory - Short Form
timeFrame: At baseline (before treatment) and within 10 days of the last in-class yoga session
measure: PROMIS-SF-depression
timeFrame: At baseline (before treatment) and within 10 days of the last in-class yoga session
measure: PROMIS-SF-sleep disturbance
timeFrame: At baseline (before treatment) and within 10 days of the last in-class yoga session
measure: Index of Self-Regulation Scale
timeFrame: At baseline (before treatment) and within 10 days of the last in-class yoga session
measure: Self-Efficacy for Managing Chronic Disease Scale
timeFrame: At baseline (before treatment) and within 10 days of the last in-class yoga session
measure: PROMIS-SF- physical function
timeFrame: At baseline (before treatment) and within 10 days of the last in-class yoga session
measure: electronic pedometer
timeFrame: At baseline (before treatment) and within 10 days of the last in-class yoga session
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Cancer Center
state: Michigan
Study officials:
References: