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

NCT02473523 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2017-03-08

Study results available
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Summary

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.

Conditions

Interventions

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

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.

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.

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

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

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

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

: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).

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02473523 on ClinicalTrials.gov