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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00975 | Registry Identifier | NCI Clinical Trial Registration Program |
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The principal investigator left the institution.
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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:
OTHER PRE-SPECIFIED OBJECTIVE:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PedsQL Cancer Module | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Median Change in PedsQL Cancer Module Score |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danielle Doria Braman, MSOT, OTR/L | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
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| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
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Two participants were enrolled between February and April 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants | Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study. Participants were to undergo the following 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| PedsQL Multidimensional Fatigue Scale | Other | 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. |
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| Biodex System 3 Dynamometer | Device | 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. |
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| Jamar Hydraulic Hand Dynamometer | Device | 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. |
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| Sit and Reach Test | Other | 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. |
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| Test of Motor Proficiency | Other | 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. |
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| Verbal Numeric Pain Scale | Other | 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. |
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| :Yoga Therapy | Other | 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). |
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Median (range) will be provided.
| Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants | Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study. Participants were to undergo the following 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | |||||||||||||||||||||
| Gender |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Day 0 |
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| 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. | Posted | At end of 4-6 weeks |
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| Other Pre-specified | Mean Change in PedsQL Cancer Module Score | Mean ± standard error will be provided. | Posted | Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later) |
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| Other Pre-specified | Median Change in PedsQL Cancer Module Score | Median (range) will be provided. | Posted | Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later) |
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| Other Pre-specified | Mean Change in PedsQL Multidimensional Fatigue Scale | Mean ± standard error will be provided. | Posted | Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later) |
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| Other Pre-specified | Median Change in PedsQL Multidimensional Fatigue Scale | Median (range) will be provided. | Posted | Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later) |
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| Other Pre-specified | 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. | Posted | Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later) |
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| ||||||||||||||||||||
| Other Pre-specified | Median Change in Quadriceps Strength | The "Biodex System 3 Dynamometer" will be utilized to measure isometric quadriceps muscle contractions. Median (range) will be provided. | Posted | Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later) |
|
| ||||||||||||||||||||
| Other Pre-specified | Mean Change in Grip Strength | A calibrated "Jamar" hydraulic hand dynamometer will be used to measure grip strength. Mean ± standard error will be provided. | Posted | Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later) |
|
| ||||||||||||||||||||
| Other Pre-specified | Median Change in Grip Strength | A calibrated "Jamar" hydraulic hand dynamometer will be used to measure grip strength. Median (range) will be provided. | Posted | Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later) |
|
| ||||||||||||||||||||
| Other Pre-specified | Mean Change in Hamstring Flexibility | Hamstring flexibility will be assessed by the Sit and Reach Test. Mean ± standard error will be provided. | Posted | Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later) |
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| Other Pre-specified | Median Change in Hamstring Flexibility | Hamstring flexibility will be assessed by the Sit and Reach Test. Median (range) will be provided. | Posted | Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later) |
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| Other Pre-specified | Mean Change in Balance | Mean ± standard error on the Bruininks-Oseretsky Test of Motor Proficiency will be provided. | Posted | Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later) |
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| Other Pre-specified | Median Change in Balance | Median (range) on the Bruininks-Oseretsky Test of Motor Proficiency will be provided. | Posted | Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later) |
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| Other Pre-specified | 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. | Posted | Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later) |
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| Other Pre-specified | 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. | Posted | Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later) |
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Adverse events were to be recorded from the on-study date until the participant was taken off study, a maximum of 6 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants | Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study. Participants were to undergo the following 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. | 0 | 1 | 0 | 1 |
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The study was terminated because the principal investigator left the institution. One participant completed only 8 of 16 sessions and was not evaluable for study objectives.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kirsten Ness, PT, PhD | St. Jude Children's Research Hospital | 901-595-5157 | kiri.ness@stjude.org |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D006689 | Hodgkin Disease |
| D008228 | Lymphoma, Non-Hodgkin |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D012856 | 4-Acetamido-4'-isothiocyanatostilbene-2,2'-disulfonic Acid |
| D015013 | Yoga |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D017879 | Isothiocyanates |
| D017953 | Isocyanates |
| D013457 | Sulfur Compounds |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
| D026241 | Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |
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