Clinical trial NCT02473523: Yoga to Alleviate Fatigue, Anxiety and Pain in Adolescents During Treatment for Lymphoma or Leukemia
Official title: Feasibility of Implementing Yoga Intervention for Adolescents at St. Jude Children's Research Hospital
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Leukemia
Hodgkin Lymphoma
Lymphoma, Non-Hodgkin's
Keywords: Fatigue
Pain Alleviation
Emotional Wellbeing
Physical Wellbeing
Yoga
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2015-06-16
Enrollment: 2
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Patients Who Are Willing to Participate
timeFrame: Day 0
measure: Rate of Patients Who Complete the Study
timeFrame: At end of 4-6 weeks
Secondary outcomes:
Other outcomes:
measure: Mean Change in PedsQL Cancer Module Score
timeFrame: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
measure: Median Change in PedsQL Cancer Module Score
timeFrame: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
measure: Mean Change in PedsQL Multidimensional Fatigue Scale
timeFrame: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
measure: Median Change in PedsQL Multidimensional Fatigue Scale
timeFrame: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
measure: Mean Change in Quadriceps Strength
timeFrame: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
measure: Median Change in Quadriceps Strength
timeFrame: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
measure: Mean Change in Grip Strength
timeFrame: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
measure: Median Change in Grip Strength
timeFrame: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
measure: Mean Change in Hamstring Flexibility
timeFrame: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
measure: Median Change in Hamstring Flexibility
timeFrame: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
measure: Mean Change in Balance
timeFrame: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
measure: Median Change in Balance
timeFrame: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
measure: Mean Change in Verbal Numeric Pain Scale
timeFrame: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
measure: Median Change in Verbal Numeric Pain Scale
timeFrame: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Danielle Doria Braman, MSOT, OTR/L
role: PRINCIPAL_INVESTIGATOR
References: