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

Not Applicable

Completed

• Conditions: Neoplasms
• Interventions: Other: Yoga

• Registration Number: NCT02899117
• Lead Sponsor: Connecticut Children's Medical Center

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

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 Timeline

• Study Start: 2014-08
• Study First Submitted: 2016-08-23
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-14
• Primary Completion: 2016-10
• Study Completion: 2017-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-15
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Yoga intervention	Yoga	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.

Primary Outcome Measures

Name	Time	Method
Assess level of interest utlizing data from the Yoga satisfaction survey	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 study visit attendance	Baseline and 8 weeks post baseline visit	Data will be assessed by study visit attendance
Feasibility of yoga intervention, assessed by institutional support	Baseline and 8 weeks post baseline visit	Data will be reviewed for evidence of institutional support
Feasibility of yoga intervention, assessed by institutional commitment of resources.	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	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	Baseline and 8 weeks post baseline visit	Data will be assessed by accrual rates
Feasibility of yoga intervention, assessed by study patient retention	Baseline and 8 weeks post baseline visit	Data will be assessed by the number of patients who remain in the study

Secondary Outcome Measures

Name	Time	Method
Improvement in sleep of Patient	Assessments are collected at baseline and 8 weeks post baseline visit	Sleep will be assessed via diary of sleep and actigraphy
Improvement in fatigue of Patient	Assessments are collected at baseline and 8 weeks post baseline visit	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.
Improvement in quality of life of Parent	Assessments are collected at baseline and 8 weeks post baseline visit	Parent quality of life will be assessed by the SF-12.
Improvement in caregiver burden of Parent.	Assessments are collected at baseline and 8 weeks post baseline visit	Caregiver burden will be assessed by the Zarit Caregiver Burden Index
Improvement in quality of life Patient	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.

Trial Locations

Locations (1)

Connecticut Children's Medical Center; 🇺🇸 Hartford, Connecticut, United States