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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 13 to 17 years
• All sexes
• No healthy volunteers
• Child

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

Leukemia, Hodgkin Lymphoma, Lymphoma, Non-Hodgkin's

Being tested

PedsQL Cancer Module, PedsQL Multidimensional Fatigue Scale, Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test

Keywords

Fatigue, Pain Alleviation, Emotional Wellbeing, Physical Wellbeing, Yoga

Medical subject headings

Leukemia, Hodgkin Disease, Lymphoma, Non-Hodgkin, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• PedsQL Cancer ModuleOther

  Also called Questionnaire

  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.

• PedsQL Multidimensional Fatigue ScaleOther

  Also called Questionnaire

  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.

• Biodex System 3 DynamometerDevice

  Also called Quadriceps Strength Measurement

  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.

• Jamar Hydraulic Hand DynamometerDevice

  Also called Grip Strength Measurement

  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.

• Sit and Reach TestOther

  Also called Hamstring Flexibility Measurement

  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.

• Test of Motor ProficiencyOther

  Also called Bruininks-Oseretsky Test of Motor Proficiency, Balance Measurement

  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.

• Verbal Numeric Pain ScaleOther

  Also called Pain Measurement

  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.

• :Yoga TherapyOther

  Also called Yoga Intervention, Yoga

  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).

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Rate of Patients Who Are Willing to Participate

   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.

   Measured: Day 0

2. Rate of Patients Who Complete the Study

   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.

   Measured: At end of 4-6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted16 Jun 2015 (estimated)
2. Study startJun 2015
3. Primary completionDec 2016
4. Study completionDec 2016

Why it stopped: The principal investigator left the institution.

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for LeukemiaStudies of the same condition, open and under way.
• More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.