Pilot Yoga Intervention to Improve Pediatric Cancer Patients' Sleep & Life Quality and Parents' Well-Being
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 23
- Locations
- 2
- Primary Endpoint
- Assess level of interest utlizing data from the Yoga satisfaction survey
Study Overview
Brief Summary
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
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Assess level of interest utlizing data from the Yoga satisfaction survey
Time Frame: Data collected at baseline and 8 weeks post baseline visit
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.
Feasibility of yoga intervention, assessed by institutional support
Time Frame: Baseline and 8 weeks post baseline visit
Data will be reviewed for evidence of institutional support
Feasibility of yoga intervention, assessed by study visit attendance
Time Frame: Baseline and 8 weeks post baseline visit
Data will be assessed by study visit attendance
Feasibility of yoga intervention, assessed by institutional commitment of resources.
Time Frame: Assessments are collected at baseline and 8 weeks post baseline visit
Data will be reviewed for institutional resource commitment
Feasibility of yoga intervention, perceived barriers/solutions
Time Frame: Change from baseline barriers/solutions at 8 weeks post baseline visit
The data will be assessed on perceived barriers/solutions.
Feasibility of yoga intervention, assessed by study accrual rates
Time Frame: Baseline and 8 weeks post baseline visit
Data will be assessed by accrual rates
Feasibility of yoga intervention, assessed by study patient retention
Time Frame: Baseline and 8 weeks post baseline visit
Data will be assessed by the number of patients who remain in the study
Secondary Outcomes
- Improvement in sleep of Patient(Assessments are collected at baseline and 8 weeks post baseline visit)
- Improvement in fatigue of Patient(Assessments are collected at baseline and 8 weeks post baseline visit)
- Improvement in quality of life of Parent(Assessments are collected at baseline and 8 weeks post baseline visit)
- Improvement in caregiver burden of Parent.(Assessments are collected at baseline and 8 weeks post baseline visit)
- Improvement in quality of life Patient(Assessments are collected at baseline and 8 weeks post baseline visit)
Investigators
Andrea Orsey
Assitant Professor Dept of Hematology Oncology
Connecticut Children's Medical Center