Yoga for Fatigue in the Survivors of Bone Marrow Transplantation

NCT03299465 | Completed DMC

• 1 other identifier: HUM00130548
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatigue; Cancer

Keywords

bone marrow transplantation; yoga

Outcome Measures

Primary Outcomes (1)

• Practice log

  Yoga practice at home will be documented on a log sheet to be filled out by participants at the end of each practice week. We will check class attendance during the weekly telephone call with the study participants. We will use a log sheet to document in-class yoga practice and location of the yoga performance. At the end of the program, the number of yoga practice hours per participant will be tabulated. This number will be used to evaluate participants' adherence to yoga practice.

  Weekly during the six-week intervention period

Secondary Outcomes (10)

• Side-effects/adverse events log

  Weekly during the six-week intervention period

• Multidimensional Fatigue Symptom Inventory

  At baseline (before treatment) and within 10 days of the last in-class yoga session

• PROMIS-SF-Fatigue

  At baseline (before treatment) and within 10 days of the last in-class yoga session

• Brief Pain Inventory - Short Form

  At baseline (before treatment) and within 10 days of the last in-class yoga session

• PROMIS-SF-depression

  At baseline (before treatment) and within 10 days of the last in-class yoga session

Study Arms (1)

Yoga arm

EXPERIMENTAL

A six-week restorative yoga intervention consisting of a weekly, 60-minute yoga group class led by a certified yoga instructor along with twice-weekly home practice using yoga DVD.

Behavioral: Yoga

Interventions

Yoga BEHAVIORAL

This is a single arm study and all participants will be assigned to a six-week restorative yoga intervention. Restorative yoga sessions will consist of gentle physical poses (asanas), breathing control (pranayama), and relaxation (savasana).

Yoga arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Cancer Center

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Fatigue; Neoplasms

Interventions

Yoga

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 3, 2017
• Study Start: December 22, 2017
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: August 10, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)