Feasibility of Implementing Yoga Intervention for Adolescents at St. Jude Children's Research Hospital
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Rate of Patients Who Complete the Study
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Participant not planning on remaining at St Jude for at least 4 weeks
- •Cognitive impairment that prevents participant from answering questions in standardized assessments
研究组 & 干预措施
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.
干预措施: PedsQL Cancer Module (Other)
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.
干预措施: PedsQL Multidimensional Fatigue Scale (Other)
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.
干预措施: Biodex System 3 Dynamometer (Device)
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.
干预措施: Jamar Hydraulic Hand Dynamometer (Device)
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.
干预措施: Sit and Reach Test (Other)
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.
干预措施: Test of Motor Proficiency (Other)
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.
干预措施: Verbal Numeric Pain Scale (Other)
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.
干预措施: :Yoga Therapy (Other)
结局指标
主要结局
Rate of Patients Who Complete the Study
时间窗: 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.
Rate of Patients Who Are Willing to Participate
时间窗: 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.
次要结局
未报告次要终点