Yoga for Fatigue in the Survivors of Bone Marrow Transplantation

Back to results

Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Yoga

About this trial

This is an interventional other trial for Fatigue focused on measuring bone marrow transplantation, yoga

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Yoga arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Side-effects/adverse events log

All subjects will be asked to complete a Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) weekly. The PRO-CTCAE questionnaire in this study includes a total of six items (numbness and tingling, dizziness, blurry vision, muscle pain, joint pain, others).

Multidimensional Fatigue Symptom Inventory

The Multidimensional Fatigue Symptom Inventory-Short Form (MFSISF) will be used to measure fatigue in the past seven days. The MFSISF includes a total of 30 items that produce five subscales: general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor. All items have a possible score of 0 to 4, 0 representing "not at all" and 4 being "extremely".

PROMIS-SF-Fatigue

The PROMIS-SF-Fatigue will be used to measure fatigue in the past seven days. The PROMIS-SF-fatigue is a unidimensional scale that measures general fatigue. It contains eight items with a possible score of 1 to 5 for each item.

Brief Pain Inventory - Short Form

The Brief Pain Inventory - Short Form (BPISF) will be used to measure pain in the past 24 hours. The BPISF is a 9-item questionnaire used to evaluate the severity of a participants' pain and the impact of pain on the patient's daily functioning.

PROMIS-SF-depression

The PROMIS-SF-depression will be used to measure depression in the past seven days. The PROMIS-SF-depression contains eight items with a possible score of 1 to 5 for each item (1: never, 5: always).

PROMIS-SF-sleep disturbance

The PROMIS-SF-sleep disturbance will be used to measure sleep disturbance in the past seven days. The PROMIS-SF-sleep disturbance contains eight items with a possible score of 1 to 5 for each item.

Index of Self-Regulation Scale

The Index of Self-Regulation Scale (ISR) is designed to measure individuals' level of self-regulation for health behaviors. The ISR contains nine items that produces three subscales: reconditioning, stimulus control, and behavioral monitoring.

Self-Efficacy for Managing Chronic Disease Scale

Self-efficacy will be measured using the Self-Efficacy for Managing Chronic Disease Scale (SEMCD). The SEMCD contains six items. Each item has a possible score of 1 to 10 (1: not at all confident, 10: totally confident).

PROMIS-SF- physical function

The PROMIS-SF- physical function contains 12 items with a possible score of 1 to 5 for each item (1: unable to do, 5: without any difficulty). All items are reversely coded. The total score can range from 12 to 60 with higher scores indicating better physical function.

electronic pedometer

The electronic pedometer is an objective measure of physical activity. It is a simple, unobtrusive device that can be placed on the belt or waistband to count the number of steps taken.

Full Information

NCT ID

NCT03299465

First Posted

September 27, 2017

Last Updated

August 8, 2018

Sponsor

University of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT03299465

Brief Title

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

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

December 22, 2017 (Actual)

Primary Completion Date

July 31, 2018 (Actual)

Study Completion Date

July 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fatigue, Cancer

Keywords

bone marrow transplantation, yoga

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Yoga arm

Arm Type

Experimental

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Yoga

Intervention Description

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).

Primary Outcome Measure Information:

Title

Practice log

Description

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.

Time Frame

Weekly during the six-week intervention period

Secondary Outcome Measure Information:

Title

Side-effects/adverse events log

Description

All subjects will be asked to complete a Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) weekly. The PRO-CTCAE questionnaire in this study includes a total of six items (numbness and tingling, dizziness, blurry vision, muscle pain, joint pain, others).

Time Frame

Weekly during the six-week intervention period

Title

Multidimensional Fatigue Symptom Inventory

Description

The Multidimensional Fatigue Symptom Inventory-Short Form (MFSISF) will be used to measure fatigue in the past seven days. The MFSISF includes a total of 30 items that produce five subscales: general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor. All items have a possible score of 0 to 4, 0 representing "not at all" and 4 being "extremely".

Time Frame