Trial Outcomes & Findings for Yoga to Alleviate Fatigue, Anxiety and Pain in Adolescents During Treatment for Lymphoma or Leukemia (NCT NCT02473523)
NCT ID: NCT02473523
Last Updated: 2017-03-08
Results Overview
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.
TERMINATED
NA
2 participants
Day 0
2017-03-08
Participant Flow
Two participants were enrolled between February and April 2016.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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2
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
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.
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Overall Study
Death
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1
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Overall Study
Lost to Follow-up
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1
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Baseline Characteristics
Yoga to Alleviate Fatigue, Anxiety and Pain in Adolescents During Treatment for Lymphoma or Leukemia
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Day 0The 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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At end of 4-6 weeksThe 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)Mean ± standard error will be provided.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)Median (range) will be provided.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)Mean ± standard error will be provided.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)Median (range) will be provided.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)The "Biodex System 3 Dynamometer" will be utilized to measure isometric quadriceps muscle contractions. Mean ± standard error will be provided.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)The "Biodex System 3 Dynamometer" will be utilized to measure isometric quadriceps muscle contractions. Median (range) will be provided.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)A calibrated "Jamar" hydraulic hand dynamometer will be used to measure grip strength. Mean ± standard error will be provided.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)A calibrated "Jamar" hydraulic hand dynamometer will be used to measure grip strength. Median (range) will be provided.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)Hamstring flexibility will be assessed by the Sit and Reach Test. Mean ± standard error will be provided.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)Hamstring flexibility will be assessed by the Sit and Reach Test. Median (range) will be provided.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)Mean ± standard error on the Bruininks-Oseretsky Test of Motor Proficiency will be provided.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)Median (range) on the Bruininks-Oseretsky Test of Motor Proficiency will be provided.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)Summary statistics of mean ± standard error will be provided. Longitudinal change for the numeric pain scale across the yoga session will be reported.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)Summary statistics of mean ± standard error will be provided. Longitudinal change for the numeric pain scale across the yoga session will be reported.
Outcome measures
Outcome data not reported
Adverse Events
Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kirsten Ness, PT, PhD
St. Jude Children's Research Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place