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

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02473523
• Other study ID #: YOGAOT
• Secondary ID: NCI-2015-00975
• Status: Terminated
• Phase: N/A
• First received: June 3, 2015
• Last updated: January 12, 2017
• Start date: June 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.
• 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.
• 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.
• 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.
• :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).

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean Change in PedsQL Cancer Module Score	Mean ± standard error will be provided.	Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
Other	Median Change in PedsQL Cancer Module Score	Median (range) will be provided.	Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
Other	Mean Change in PedsQL Multidimensional Fatigue Scale	Mean ± standard error will be provided.	Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
Other	Median Change in PedsQL Multidimensional Fatigue Scale	Median (range) will be provided.	Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
Other	Mean Change in Quadriceps Strength	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)
Other	Median Change in Quadriceps Strength	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)
Other	Mean Change in Grip Strength	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)
Other	Median Change in Grip Strength	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)
Other	Mean Change in Hamstring Flexibility	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)
Other	Median Change in Hamstring Flexibility	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)
Other	Mean Change in Balance	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)
Other	Median Change in Balance	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)
Other	Mean Change in Verbal Numeric Pain Scale	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)
Other	Median Change in Verbal Numeric Pain Scale	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)
Primary	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.	Day 0
Primary	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.	At end of 4-6 weeks

External Links

•   Clinical Trials Open at St. Jude
•   St. Jude Children's Research Hospital