- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02899117
Yoga Intervention to Improve Pediatric Cancer Patients' Sleep & Life Quality and Parents' Well-Being
Pilot Yoga Intervention to Improve Pediatric Cancer Patients' Sleep & Life Quality and Parents' Well-Being
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Connecticut
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Hartford, Connecticut, United States, 06106
- Connecticut Children's Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Yoga intervention
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.
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There are 4 yoga sessions completed with a certified instructor during cancer treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of yoga intervention, perceived barriers/solutions
Time Frame: Change from baseline barriers/solutions at 8 weeks post baseline visit
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The data will be assessed on perceived barriers/solutions.
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Change from baseline barriers/solutions at 8 weeks post baseline visit
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Assess level of interest utlizing data from the Yoga satisfaction survey
Time Frame: Data collected at baseline and 8 weeks post baseline visit
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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
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Feasibility of yoga intervention, assessed by study accrual rates
Time Frame: Baseline and 8 weeks post baseline visit
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Data will be assessed by accrual rates
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Baseline and 8 weeks post baseline visit
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Feasibility of yoga intervention, assessed by study visit attendance
Time Frame: Baseline and 8 weeks post baseline visit
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Data will be assessed by study visit attendance
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Baseline and 8 weeks post baseline visit
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Feasibility of yoga intervention, assessed by study patient retention
Time Frame: Baseline and 8 weeks post baseline visit
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Data will be assessed by the number of patients who remain in the study
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Baseline and 8 weeks post baseline visit
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Feasibility of yoga intervention, assessed by institutional support
Time Frame: Baseline and 8 weeks post baseline visit
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Data will be reviewed for evidence of institutional support
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Baseline and 8 weeks post baseline visit
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Feasibility of yoga intervention, assessed by institutional commitment of resources.
Time Frame: Assessments are collected at baseline and 8 weeks post baseline visit
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Data will be reviewed for institutional resource commitment
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Assessments are collected at baseline and 8 weeks post baseline visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in sleep of Patient
Time Frame: Assessments are collected at baseline and 8 weeks post baseline visit
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Sleep will be assessed via diary of sleep and actigraphy
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Assessments are collected at baseline and 8 weeks post baseline visit
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Improvement in quality of life Patient
Time Frame: Assessments are collected at baseline and 8 weeks post baseline visit
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Quality of life will be assessed by PedsQL 4.0 and PedsQL 3.0 Cancer Module.
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Assessments are collected at baseline and 8 weeks post baseline visit
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Improvement in fatigue of Patient
Time Frame: Assessments are collected at baseline and 8 weeks post baseline visit
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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.
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Assessments are collected at baseline and 8 weeks post baseline visit
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Improvement in quality of life of Parent
Time Frame: Assessments are collected at baseline and 8 weeks post baseline visit
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Parent quality of life will be assessed by the SF-12.
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Assessments are collected at baseline and 8 weeks post baseline visit
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Improvement in caregiver burden of Parent.
Time Frame: Assessments are collected at baseline and 8 weeks post baseline visit
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Caregiver burden will be assessed by the Zarit Caregiver Burden Index
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Assessments are collected at baseline and 8 weeks post baseline visit
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Collaborators and Investigators
Investigators
- Principal Investigator: Andrea Orsey, MD, Connecticut Childrens Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Pilot Yoga 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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