Yoga Intervention to Improve Pediatric Cancer Patients' Sleep & Life Quality and Parents' Well-Being

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Yoga Intervention to Improve Pediatric Cancer Patients' Sleep & Life Quality and Parents' Well-Being

Conditions
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Neoplasms

Intervention / Treatment
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* Other: Yoga


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parents and children (ages 8-18) undergoing treatment (chemotherapy and/or radiation therapy) for cancer. Cancer diagnosis, between the ages of 8-18 year, English speaking, and medically cleared to participate in yoga. Parents will be eligible if they are over 18 years old, English speaking, and physically able to participate in yoga. Exclusion Criteria: Children and parents not meeting inclusion criteria

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga intervention<br>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. | Other: Yoga<br>* There are 4 yoga sessions completed with a certified instructor during cancer treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | Data will be reviewed for institutional resource commitment | Assessments are collected at baseline and 8 weeks post baseline visit | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |