Yoga to Alleviate Fatigue, Anxiety and Pain in Adolescents During Treatment for Lymphoma or Leukemia

January 17, 2017 updated by: St. Jude Children's Research Hospital

Feasibility of Implementing Yoga Intervention for Adolescents at St. Jude Children's Research Hospital

Researchers at St. Jude Children's Research Hospital want to investigate the feasibility of a yoga intervention for adolescents receiving treatment for lymphoma or leukemia. Adolescents who participate in the program may experience improved physical and psychosocial measures. Improvements in these areas may increase participation in meaningful activity and improve quality of life.

Adolescents diagnosed with cancer may experience more fatigue, anxiety and pain during treatment. Yoga is considered a complementary alternative medicine (CAM) that has been implemented into some pediatric oncology rehabilitation programs and has been shown to be beneficial in both inpatient and outpatient settings. It may decrease anxiety and increase quality of life and hamstring flexibility in teens.

PRIMARY OBJECTIVE:

  • To determine the feasibility of yoga intervention for adolescents during lymphoma and leukemia treatment.

OTHER PRE-SPECIFIED OBJECTIVE:

  • To obtain pilot data regarding efficacy of yoga on pain, quality of life, fatigue and physical performance.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Those who consent to participate will participate in 60-minute yoga sessions 2-3 times per week for 4-6 weeks. Only specified yoga poses will be implemented during the classes.

The study will be done in three parts: initial evaluation, yoga therapy, and follow-up evaluations.

INITIAL EVALUATION: Participants will complete the PedsQL Cancer Module questionnaire and the PedsQL Multidimensional Fatigue Scale questionnaire. Physical performance including quadriceps strength, grip strength, hamstring flexibility, and balance, will be assessed.

YOGA THERAPY: The principal investigator (PI) is a certified yoga therapist (CYT) and is a registered yoga teacher with 500 hours of training (RYT 500). Participants will take part in a 60-minute yoga session conducted by the PI 2-3 times a week for 4-6 weeks, during which time they must complete 8-12 yoga sessions. The yoga intervention includes these parts: warm-up, strengthening, increasing hamstring flexibility, balance and relaxation. Yoga poses will be used for each yoga session from a predetermined roster depending on individual adolescent abilities. This will allow for a tailored but standardized yoga intervention. Modifications including chairs, straps and blocks will be allowed to promote appropriate form and use of these props will be recorded. Immediately before and after each yoga session, the therapist will record pain with the verbal numeric pain scale.

FOLLOW-UP EVALUATIONS: After completion of the 4-6 weeks of yoga therapy, participants will complete all assessments and physical performance measures that were done in the initial evaluation.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • St. Jude Children's Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient being treated at St. Jude Children's Research Hospital
  • Diagnosis of lymphoma or leukemia as documented in medical record
  • Physician approval to participate in intervention
  • Ages 13-17 years
  • Ability to come to standing from seated position without assistance
  • Parent or legal guardian consent
  • Adolescent gives assent
  • English speaking

Exclusion Criteria:

  • Participant not planning on remaining at St Jude for at least 4 weeks
  • Cognitive impairment that prevents participant from answering questions in standardized assessments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants

Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.

Interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency.
Other: PedsQL Cancer Module
The PedsQL cancer module acute version is a 27 item assessment that includes eight scales including pain (2 items), nausea (5 items), anxiety related to procedures (3 items), anxiety related to treatment (3 items), worry (3items), cognitive problems (5 items), perceived physical appearance and communication (3 items). This assessment will take approximately 15-30 minutes to complete.
Other Names:
  • Questionnaire
Other: PedsQL Multidimensional Fatigue Scale
The Multidimensional Fatigue Scale is an 18 item questionnaire encompassing 3 subscales including general fatigue (6 items), sleep and rest fatigue (6 items) and cognitive fatigue (6 items). This assessment will take approximately 10-20 minutes to complete.
Other Names:
  • Questionnaire
Device: Biodex System 3 Dynamometer
The "Biodex System 3 Dynamometer" will be used to measure isometric quadriceps muscle contractions. Participants will be stabilized in the chair with abdominal and shoulder straps. The isometric tests for knee extension will be done on both dominant and non-dominant leg. The tests consist of 3 maximal muscle contractions each lasting five seconds separated by 40 second rest intervals. This assessment will take approximately 10 minutes to complete.
Other Names:
  • Quadriceps Strength Measurement
Device: Jamar Hydraulic Hand Dynamometer
A calibrated "Jamar" hydraulic hand dynamometer will be used to measure grip strength. The participant will be seated in a chair with elbow flexion to 90 degrees against torso and the forearm in neutral. The participant will grasp the device and the handle will be adjusted so that digits are able to comfortably grasp the device. The maximum score after 2 trials will be recorded as grip strength for both right and left hand. This assessment will take no more than 5 minutes to complete.
Other Names:
  • Grip Strength Measurement
Other: Sit and Reach Test
Hamstring flexibility will be assessed by the Sit and Reach Test. The sit and reach is a test to measure hip, hamstring and lower back flexibility. To measure flexibility participants will perform the YMCA sit and reach test. Participants will sit down without shoes or socks with the soles of their feet against the vertical platform of the sit-and-reach box located at the 26 cm (a little over 10 inches) mark. Participants keep their legs straight and their hands overlapped, while reaching for a less than maximum distance twice as a warm-up. This test will take no more than 5 minutes to complete.
Other Names:
  • Hamstring Flexibility Measurement
Other: Test of Motor Proficiency
The Bruininks-Oseretsky Test of Motor Proficiency is a 9 item standardized assessment that includes standing with feet on a line with eyes open and closed, standing on a line with one foot with eyes open and closed, standing on a balance beam on one leg with eyes open and closed and standing heel to toe on a balance beam. These tests will be administered no more than two times with a maximum score of 10 seconds. Two additional subtests include walking forward on a line and walking heel to toe on a line for a maximum of 6 steps for both tasks. Total time to complete this test is approximately 10-20 minutes.
Other Names:
  • Bruininks-Oseretsky Test of Motor Proficiency
  • Balance Measurement
Other: Verbal Numeric Pain Scale
The verbal numeric pain scale will be administered before and after each yoga session. The principal investigator (PI) will ask the participant about his/her pain on a scale of 0-10 and the PI will record the number. This will take less than 10 seconds.
Other Names:
  • Pain Measurement
Other: :Yoga Therapy
Those who consent will participate in 60-minute yoga sessions 2-3 times per week for 4-6 weeks. Only specified yoga poses will be implemented during the classes. Additional detail is included in the Description sections of this registration. The principal investigator is a Certified Yoga Therapist (CYT) and is a registered yoga teacher with 500 hours of training (RYT 500).
Other Names:
  • Yoga
  • Yoga Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Patients Who Are Willing to Participate
Time Frame: Day 0
The rate of participants who are willing to participate on this protocol to the total number of participants approached. It is anticipated that 50% approached patients will agree to participate on the study. Twenty five patients will be approached and asked to participate in the study. If more than 6 patients out of 25 approached patients refuse to participate in the study, the study will be closed, and it will be concluded that the trial is not feasible.
Day 0
Rate of Patients Who Complete the Study
Time Frame: At end of 4-6 weeks
The rate of enrolled and consented patients who complete the 60-minute yoga sessions offered over a 4-6 week period to the total number of participants on the study. It is hypothesized that 60% of those participants will complete the intervention. Thus, if more than 5 patients can not complete the intervention, then it will be concluded that the trial is not feasible.
At end of 4-6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in PedsQL Cancer Module Score
Time Frame: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
Mean ± standard error will be provided.
Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
Median Change in PedsQL Cancer Module Score
Time Frame: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
Median (range) will be provided.
Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
Mean Change in PedsQL Multidimensional Fatigue Scale
Time Frame: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
Mean ± standard error will be provided.
Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
Median Change in PedsQL Multidimensional Fatigue Scale
Time Frame: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
Median (range) will be provided.
Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
Mean Change in Quadriceps Strength
Time Frame: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
The "Biodex System 3 Dynamometer" will be utilized to measure isometric quadriceps muscle contractions. Mean ± standard error will be provided.
Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
Median Change in Quadriceps Strength
Time Frame: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
The "Biodex System 3 Dynamometer" will be utilized to measure isometric quadriceps muscle contractions. Median (range) will be provided.
Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
Mean Change in Grip Strength
Time Frame: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
A calibrated "Jamar" hydraulic hand dynamometer will be used to measure grip strength. Mean ± standard error will be provided.
Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
Median Change in Grip Strength
Time Frame: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
A calibrated "Jamar" hydraulic hand dynamometer will be used to measure grip strength. Median (range) will be provided.
Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
Mean Change in Hamstring Flexibility
Time Frame: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
Hamstring flexibility will be assessed by the Sit and Reach Test. Mean ± standard error will be provided.
Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
Median Change in Hamstring Flexibility
Time Frame: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
Hamstring flexibility will be assessed by the Sit and Reach Test. Median (range) will be provided.
Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
Mean Change in Balance
Time Frame: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
Mean ± standard error on the Bruininks-Oseretsky Test of Motor Proficiency will be provided.
Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
Median Change in Balance
Time Frame: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
Median (range) on the Bruininks-Oseretsky Test of Motor Proficiency will be provided.
Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
Mean Change in Verbal Numeric Pain Scale
Time Frame: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
Summary statistics of mean ± standard error will be provided. Longitudinal change for the numeric pain scale across the yoga session will be reported.
Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
Median Change in Verbal Numeric Pain Scale
Time Frame: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
Summary statistics of mean ± standard error will be provided. Longitudinal change for the numeric pain scale across the yoga session will be reported.
Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Jude Children's Research Hospital

Investigators

  • Principal Investigator: Danielle Doria Braman, MSOT, OTR/L, St. Jude Children's Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

June 3, 2015

First Submitted That Met QC Criteria

June 11, 2015

First Posted (Estimate)

June 16, 2015

Study Record Updates

Last Update Posted (Actual)

March 8, 2017

Last Update Submitted That Met QC Criteria

January 17, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YOGAOT
  • NCI-2015-00975 (Registry Identifier: NCI Clinical Trial Registration Program)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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