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The proposed project will examine feasibility and preliminary efficacy of a yoga intervention in the pediatric oncology unit at Connecticut Children's Medical Center (CCMC) and includes two parts: (1) a survey of children and parents regarding preferences (e.g., convenient days/times), experiences and expectations regarding yoga (including barriers and positive expectancies) and (2) an eight week clinical trial of a yoga intervention in 10 pairs of children and parents.
The specific aims and hypotheses for this seed grant are to collect and assess data on:
Aim 1 feasibility - perceived barriers/solutions, interest and accrual rates, attendance per session, participant retention, evidence of institutional support and resource commitment Hypothesis 1: A yoga intervention is feasible among pediatric oncology patients and their parents; (2) preliminary efficacy - including effect sizes for calculating power Hypothesis 2a: A yoga intervention improves pediatric oncology patients' fatigue, QOL, and sleep.
Hypothesis 2b: A yoga intervention improves parental QOL and caregiver burden.
We will be using the following questionnaires and scales to help answer the quesitons related to the hypotheses and aims:
PedsQL 4.0 PedsQL 3.0 Cancer Module The Fatigue Scale SleepDiary Actigraphy data. Child Home Yoga Practice Diary Satisfaction survey
Questionnaires noted below are given only to the parents:
SF-12 Zarit Caregiver Burden Index Yoga Satisfaction Survey
Study participants will have 4 yoga sessions and the questionnaires and surveys are done prior to the first yoga session and after the last yoga session.
The yoga sessions are created with both the study participant and a certified yoga instructor. The patients are given the yoga routine to practice at home at their leisure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yoga intervention | Experimental | Patients in the yoga intervention group will have 4 yoga sessions with a certified yoga instructor while they are in the cancer clinic or on the inpatient floor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yoga | Other | There are 4 yoga sessions completed with a certified instructor during cancer treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of yoga intervention, perceived barriers/solutions | The data will be assessed on perceived barriers/solutions. | Change from baseline barriers/solutions at 8 weeks post baseline visit |
| Assess level of interest utlizing data from the Yoga satisfaction survey | Data will be assessed by level of interest utilizing data from the yoga satisfcation survey. Most responses will be on a Likert scale while some specific questions will be other formats (i.e. open ended questions). These questions will help to inform the intervention. | Data collected at baseline and 8 weeks post baseline visit |
| Feasibility of yoga intervention, assessed by study accrual rates | Data will be assessed by accrual rates | Baseline and 8 weeks post baseline visit |
| Feasibility of yoga intervention, assessed by study visit attendance | Data will be assessed by study visit attendance | Baseline and 8 weeks post baseline visit |
| Feasibility of yoga intervention, assessed by study patient retention | Data will be assessed by the number of patients who remain in the study | Baseline and 8 weeks post baseline visit |
| Feasibility of yoga intervention, assessed by institutional support | Data will be reviewed for evidence of institutional support | Baseline and 8 weeks post baseline visit |
| Feasibility of yoga intervention, assessed by institutional commitment of resources. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in sleep of Patient | Sleep will be assessed via diary of sleep and actigraphy | Assessments are collected at baseline and 8 weeks post baseline visit |
| Improvement in quality of life Patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Orsey, MD | Connecticut Childrens Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015013 | Yoga |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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Data will be reviewed for institutional resource commitment |
| Assessments are collected at baseline and 8 weeks post baseline visit |
Quality of life will be assessed by PedsQL 4.0 and PedsQL 3.0 Cancer Module.
| Assessments are collected at baseline and 8 weeks post baseline visit |
| Improvement in fatigue of Patient | Fatigue will be assessed by the Fatigue Scale (FS). The Fatigue Scale for children (FS-C) between 8-12 years and the Fatigue Scale for adolescent (FS-A) between 13-18 years. | Assessments are collected at baseline and 8 weeks post baseline visit |
| Improvement in quality of life of Parent | Parent quality of life will be assessed by the SF-12. | Assessments are collected at baseline and 8 weeks post baseline visit |
| Improvement in caregiver burden of Parent. | Caregiver burden will be assessed by the Zarit Caregiver Burden Index | Assessments are collected at baseline and 8 weeks post baseline visit |
| D026241 |
| Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |